<clinical_study>
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    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03811574</url>
  </required_header>
  <id_info>
    <org_study_id>NN9536-4382</org_study_id>
    <secondary_id>U1111-1201-1629</secondary_id>
    <nct_id>NCT03811574</nct_id>
  </id_info>
  <brief_title>STEP 6: Research Study Investigating How Well Semaglutide Works in People Living With Overweight or Obesity</brief_title>
  <acronym>STEP 6</acronym>
  <official_title>Effect and Safety of Semaglutide Once-weekly in East Asian Subjects With Overweight or Obesity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novo Nordisk A/S</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novo Nordisk A/S</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will look at the change in participants' body weight from the start to the end of&#xD;
      the study. This is to compare the effect on body weight in people taking semaglutide (a new&#xD;
      medicine) and people taking &quot;dummy&quot; medicine. In addition to taking the medicine,&#xD;
      participants will have talks with study staff about healthy food choices, how to be more&#xD;
      physically active and what participants can do to lose weight. Participants will either get&#xD;
      semaglutide or &quot;dummy&quot; medicine - which treatment participants get is decided by chance.&#xD;
      Participants are three times as likely to get semaglutide as &quot;dummy&quot; medicine. Participants&#xD;
      will need to take 1 injection once a week. The study medicine is injected with a thin needle&#xD;
      in a skinfold in the stomach, thigh or upper arm. The study will last for about one and a&#xD;
      half years. Participants will have 14 clinic visits and 11 phone calls with the study doctor.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 21, 2019</start_date>
  <completion_date type="Actual">November 20, 2020</completion_date>
  <primary_completion_date type="Actual">November 20, 2020</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Sponsor staff involved in the clinical trial is masked according to company standard procedures</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Body Weight (%)</measure>
    <time_frame>Baseline (week 0), week 68</time_frame>
    <description>Change from baseline (week 0) in body weight for 'in-trial' observation period at week 68 is presented. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact (week 75).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 5%</measure>
    <time_frame>At week 68</time_frame>
    <description>Number of participants who achieved greater than or equal to (≥) 5% weight loss at week 68 for in-trial observation period is presented. In the reported data, 'Yes' infers the number of participants who have achieved ≥ 5% weight loss, whereas 'No' infers the number of participants who have not achieved ≥ 5% weight loss. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact (week 75).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 10%</measure>
    <time_frame>At week 68</time_frame>
    <description>Number of participants who achieved greater than or equal to (≥) 10% weight loss at week 68 is presented. In the reported data, 'Yes' infers the number of participants who have achieved ≥ 10% weight loss, whereas 'No' infers the number of participants who have not achieved ≥ 10% weight loss. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 15%</measure>
    <time_frame>At week 68</time_frame>
    <description>Number of participants who achieved greater than or equal to (≥) 15% weight loss at week 68 is presented. In the reported data, 'Yes' infers the number of participants who have achieved ≥ 15% weight loss, whereas 'No' infers the number of participants who have not achieved ≥ 15% weight loss. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomization to last trial-related subject-site contact.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 20%</measure>
    <time_frame>At week 68</time_frame>
    <description>Number of participants who achieved greater than or equal to (≥) 20% weight loss at week 68 is presented. In the reported data, 'Yes' infers the number of participants who have achieved ≥ 20% weight loss, whereas 'No' infers the number of participants who have not achieved ≥ 20% weight loss. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Waist Circumference Measured Midway Between the Lower Rib Margin and the Iliac Crest</measure>
    <time_frame>Baseline (week 0) to week 68</time_frame>
    <description>Change in waist circumference measured midway between the lower rib margin and the iliac crest from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Waist Circumference Measured According to the JASSO (Japan Society for the Study of Obesity) Guideline</measure>
    <time_frame>Baseline (week 0) to week 68</time_frame>
    <description>Change in Waist circumference measured according to the JASSO guideline from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Body Weight (Kg)</measure>
    <time_frame>Baseline (week 0) to week 68</time_frame>
    <description>Change in body weight from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Body Mass Index (BMI)</measure>
    <time_frame>Baseline (week 0) to week 68</time_frame>
    <description>Change in BMI from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Visceral Fat Area (VFA) (%)</measure>
    <time_frame>Baseline (week 0) to week 68</time_frame>
    <description>Change in VFA from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Visceral Fat Area (VFA) Centimeter Square (cm^2)</measure>
    <time_frame>Baseline (week 0) to week 68</time_frame>
    <description>Change in VFA from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in HbA1c (%)</measure>
    <time_frame>Baseline (week 0) to week 68</time_frame>
    <description>Change in glycosylated haemoglobin (HbA1c) from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in HbA1c (mmol/Mol)</measure>
    <time_frame>Baseline (week 0) to week 68</time_frame>
    <description>Change in glycosylated haemoglobin (HbA1c) from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fasting Plasma Glucose</measure>
    <time_frame>Baseline (week 0) to week 68</time_frame>
    <description>Change in fasting plasma glucose from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomization to last trial-related subject-site contact.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fasting Serum Insulin-ratio to Baseline</measure>
    <time_frame>Baseline (week 0) to week 68</time_frame>
    <description>Change in fasting serum insulin measured as milli-international units per milliliter (mIU/mL) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Systolic Blood Pressure</measure>
    <time_frame>Baseline (week 0) to week 68</time_frame>
    <description>Change in systolic blood pressure from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Diastolic Blood Pressure</measure>
    <time_frame>Baseline (week 0) to week 68</time_frame>
    <description>Change in diastolic blood pressure from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Total Cholesterol-ratio to Baseline</measure>
    <time_frame>Baseline (week 0) to week 68</time_frame>
    <description>Change in total cholesterol measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in High-density Lipoproteins (HDL)-Ratio to Baseline</measure>
    <time_frame>Baseline (week 0) to week 68</time_frame>
    <description>Change in HDL measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Low-density Lipoproteins (LDL)-Ratio to Baseline</measure>
    <time_frame>Baseline (week 0) to week 68</time_frame>
    <description>Change in LDL measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomization to last trial-related subject-site contact.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Very Low-density Lipoproteins (VLDL)-Ratio to Baseline</measure>
    <time_frame>Baseline (week 0) to week 68</time_frame>
    <description>Change in VLDL measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomization to last trial-related subject-site contact.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Free Fatty Acids-ratio to Baseline</measure>
    <time_frame>Baseline (week 0) to week 68</time_frame>
    <description>Change in free fatty acids measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Triglycerides-ratio to Baseline</measure>
    <time_frame>Baseline (week 0) to week 68</time_frame>
    <description>Change in triglycerides measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in High Sensitivity C-reactive Protein (hsCRP)-Ratio to Baseline</measure>
    <time_frame>Baseline (week 0) to week 68</time_frame>
    <description>Change in hsCRP measured in milligram per ilitre (mg/L) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Plasminogen Activator Inhibitor-1 Activity-ratio to Baseline</measure>
    <time_frame>Baseline (week 0) to week 68</time_frame>
    <description>Change in plasminogen activator inhibitor-1 (PAI-1) activity measured in arbritary units per milliliter (AU/ml) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Short Form 36 v2.0 Acute (SF-36) Score</measure>
    <time_frame>Baseline (week 0) to week 68</time_frame>
    <description>SF-36 is a 36-item patient-reported survey of patient health that measures participant's overall health-related quality of life (HRQoL). SF-36v2™ questionnaire measured eight domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). This endpoint shows results for all the domains. The 0-100 scale scores from SF-36 were converted to norm-based scores to enable a direct interpretation in relation to distribution of scores in the 2009 U.S. general population. In metric of norm-based scores, 50 and 10 corresponds to mean and standard deviation respectively. Change from week 0 in domain scores and component summary scores were evaluated at week 68. A positive change score indicates an improvement since baseline. These endpoints were evaluated based on data from in-trial observation period which is uninterrupted time interval from randomisation to last contact with trial site.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Impact of Weight on Quality of Life-lite for Clinical Trials (IWQOL-Lite for CT) Score</measure>
    <time_frame>Baseline (week 0) to week 68</time_frame>
    <description>The Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite-CT) is designed to assess the impact of changes in weight on patients' quality of life within the context of clinical trials. IWQOL-Lite-CT is a 20-item questionnaire-based instrument used to assess the impact of body weight changes on participant's overall health-related quality of life (HRQoL). All IWQOL-Lite-CT composite scores range from 0 to 100, with higher scores reflecting better levels of functioning. This endpoint shows results for 'physical function score' physical and psychosocial domains, and for total'. The endpoint was evaluated based on the data from in-trial observation period which is the uninterrupted time interval from randomisation to last contact with trial site.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Achieve (Yes/no): Responder Definition Value for SF-36 Physical Functioning Score</measure>
    <time_frame>At week 68</time_frame>
    <description>The number of participants experiencing a meaningful within participant improvement in SF-36 Physical function after 68 weeks was determined based on 3.7 threshold. The threshold of 3.7 is specific for overweight or obese population included in the study and calculated using patient global rating anchor questionnaires to reflect participants' own perspective based on Food and Drug Administration (FDA) recommendations. In the reported data, &quot;Yes&quot; infers the number of participants who have achieved an improvement in score greater than or equal to the threshold and &quot;No&quot; infers number of participants who have not achieved an improvement in score greater than or equal to the threshold. The endpoint was evaluated based on in-trial observation period which is the uninterrupted time interval from randomisation to last contact with trial site.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Achieve (Yes/no): Responder Definition Value for IWQoL-Lite for CT Physical Function (5-items) Score</measure>
    <time_frame>At week 68</time_frame>
    <description>The number of participants experiencing a meaningful within participant improvement in IWQOL-Lite-CT physical function after 68 weeks was determined based on thresholds of 14.6. The threshold of 14.6 is specific for the population with overweight or obesity included in the study and calculated using patient global rating anchor questionnaires to reflect participants' own perspective based on FDA recommendations. In the reported data, &quot;Yes&quot; infers the number of participants who have achieved an improvement in score greater than or equal to the threshold and &quot;No&quot; infers the number of participants who have not achieved an improvement in score greater than or equal to the threshold. The endpoint was evaluated based on in-trial observation period which is the uninterrupted time interval from randomisation to last contact with trial site.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Achieved (Yes/no): HbA1c &lt;7.0% (53 mmol/Mol)</measure>
    <time_frame>At week 68</time_frame>
    <description>Number of participants who achieved HbA1c &lt;7% (53 mmol/mol) at week 68 is presented. In the reported data, &quot;Yes&quot; infers the number of participants who have achieved HbA1c values less than the 7% and &quot;No&quot; infers the number of participants who have not achieved HbA1c values less than the 7%. The endpoint was evaluated based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Achieved (Yes/no): HbA1c ≤6.5% (48 mmol/Mol)</measure>
    <time_frame>At week 68</time_frame>
    <description>Number of participants who achieved HbA1c ≤6.5% (48 mmol/mol) at week 68 is presented. In the reported data, &quot;Yes&quot; infers the number of participants who have achieved HbA1c values less than or equal to 6.5% and &quot;No&quot; infers the number of participants who have not achieved HbA1c values less than or equal to 6.5%. The endpoint was evaluated based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Treatment-emergent AEs</measure>
    <time_frame>Week 0 to week 75</time_frame>
    <description>An adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. All AEs mentioned here are treatment emergent adverse events (TEAE) defined as an event with onset during the on-treatment observation period. On-treatment observation period: the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Serious Adverse Events</measure>
    <time_frame>Week 0 to week 75</time_frame>
    <description>A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. SAE results occurred from week 0 to week 75 is presented based on the on-treatment observation, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes</measure>
    <time_frame>Week 0 to week 75</time_frame>
    <description>Hypoglycaemic episodes with onset during on-treatment observation period were considered treatment-emergent. Number of treatment emergent severe or BG confirmed symptomatic hypoglycaemia episodes with onset during on-treatment observation period were presented. Severe hypoglycaemia: episode requiring assistance of another person to administer carbohydrate, glucagon or take other corrective actions. plasma glucose (PG) concentrations may not be available during an event, but neurological recovery following return of PG to normal is considered sufficient evidence that event was induced by low PG concentration. BG confirmed symptomatic hypoglycaemia: episode that is BG confirmed by PG value &lt;3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. On-treatment observation period is interval from date of first trial product administration (week 0) to date of last trial product administration (week 68) plus 7-week follow-up period and excluding any off-treatment time intervals.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Pulse</measure>
    <time_frame>Baseline (week 0) to week 68</time_frame>
    <description>Change in pulse from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Amylase: Ratio to Baseline</measure>
    <time_frame>Baseline (week 0) to week 68</time_frame>
    <description>Change in amylase measured in units/liter (U/L) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Lipase: Ratio to Baseline</measure>
    <time_frame>Baseline (week 0) to week 68</time_frame>
    <description>Change in lipase measured in units/litre (U/L) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Calcitonin: Ratio to Baseline</measure>
    <time_frame>Baseline (week 0) to week 68</time_frame>
    <description>Change in calcitonin measured in nanogram/litre (ng/L) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in QTCF Interval</measure>
    <time_frame>Baseline (week 0) to week 68</time_frame>
    <description>Change in QTCF Interval from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">401</enrollment>
  <condition>Overweight</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Semaglutide 2.4 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive semaglutide injections once-weekly for 68 weeks. Participants will be initiated at a once-weekly dose of 0.25 mg and follow a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), until the target dose (2.4 mg) is reached after 16 weeks. Participants will continue semaglutide 2.4 mg until week 68.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo (semaglutide 2.4 mg)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will receive placebo (semaglutide) injections once-weekly for 68 weeks. Participants will be initiated at a once-weekly dose of 0.25 mg and follow a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), until the target dose (2.4 mg) is reached after 16 weeks. Participants will continue placebo (semaglutide 2.4 mg) until week 68.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Semaglutide 1.7 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive semaglutide injections once-weekly for 68 weeks. Participants will be initiated at a once-weekly dose of 0.25 mg and follow a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), until the target dose (1.7 mg) is reached after 12 weeks. Participants will continue semaglutide 1.7 mg until week 68.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo (semaglutide 1.7 mg)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will receive placebo (semaglutide) injections once-weekly for 68 weeks. Participants will be initiated at a once-weekly dose of 0.25 mg and follow a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), until the target dose (1.7 mg) is reached after 12 weeks. Participants will continue placebo (semaglutide 1.7) until week 68.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Semaglutide</intervention_name>
    <description>Semaglutide injections will be administered once-weekly by a pre-filled pen-injector at the same day of the week (to the extent possible). Injections may be administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals.</description>
    <arm_group_label>Semaglutide 1.7 mg</arm_group_label>
    <arm_group_label>Semaglutide 2.4 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo (semaglutide)</intervention_name>
    <description>Placebo (semaglutide) injections will be administered once-weekly by a pre-filled pen-injector at the same day of the week (to the extent possible). Injections may be administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals.</description>
    <arm_group_label>Placebo (semaglutide 1.7 mg)</arm_group_label>
    <arm_group_label>Placebo (semaglutide 2.4 mg)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female, age more than or equal to 18 years at the time of signing informed&#xD;
             consent&#xD;
&#xD;
          -  BMI more than or equal to 27.0 kg/m^2 with more than or equal to 2 weight related&#xD;
             comorbidities (treated or untreated) or BMI more than or equal to 35.0 kg/m^2 with&#xD;
             more than or equal to 1 weight related comorbidity (treated or untreated) according to&#xD;
             the JASSO guideline. At least one comorbidity should be hypertension or dyslipidaemia&#xD;
             (Japan only: or T2D)&#xD;
&#xD;
          -  History of at least one self-reported unsuccessful dietary effort to lose body weight&#xD;
&#xD;
          -  For subjects with T2D at screening (Japan only): a) Diagnosed with T2D more than or&#xD;
             equal to 180 days prior to the day of screening. b) HbA1c 7.0-10.0% (53-86 mmol/mol)&#xD;
             (both inclusive)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A self-reported change in body weight more than 5 kg (11 lbs) within 90 days before&#xD;
             screening irrespective of medical records&#xD;
&#xD;
          -  For subjects without T2D at screening: HbA1c more than or equal to 48 mmol/mol (6.5%)&#xD;
             as measured by the central laboratory at screening&#xD;
&#xD;
          -  For subjects with T2D at screening (Japan only): a) Renal impairment measured as&#xD;
             estimated glomerular filtration rate (eGFR) value of less than 30 mL/min/1.73 m^2&#xD;
             (less than 60 mL/min/1.73 m^2 in subjects treated with sodium-glucose co-transporter 2&#xD;
             inhibitor (SGLT2i)) according to chronic kidney disease epidemiology (CKD-EPI)&#xD;
             creatinine equation as defined by kidney disease improving global outcome (KDIGO) 2012&#xD;
             by the central laboratory at screening. b) Uncontrolled and potentially unstable&#xD;
             diabetic retinopathy or maculopathy. Verified by a pharmacologically pupil-dilated&#xD;
             fundus examination performed by an ophthalmologist or another suitably qualified&#xD;
             health care provider within the past 90 days prior to screening or in the period&#xD;
             between screening and randomisation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Reporting Anchor and Disclosure (1452)</last_name>
    <role>Study Director</role>
    <affiliation>Novo Nordisk A/S</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Adachi-ku, Tokyo</city>
        <zip>123-0845</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Bunkyo-ku, Tokyo</city>
        <zip>113-8655</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chitose, Hokkaido</city>
        <zip>066-0032</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chuo-ku, Tokyo</city>
        <zip>103-0002</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chuo-ku,Tokyo</city>
        <zip>103-0025</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Gunma</city>
        <zip>373-0036</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Ibaraki</city>
        <zip>311-0113</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kanagawa</city>
        <zip>232-0064</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kashiwara-shi, Osaka</city>
        <zip>582-0005</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kobe, Hyogo</city>
        <zip>650-0017</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kumamoto</city>
        <zip>862-0976</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Miyazaki</city>
        <zip>880-0034</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Sapporo-shi, Hokkaido</city>
        <zip>004-0004</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Shimotsuke-shi, Tochigi</city>
        <zip>329-0433</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Suita-shi, Osaka</city>
        <zip>565-0853</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>103-0027</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>103-0028</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>104-0031</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>125-0054</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>160-0008</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Toyama-shi, Toyama</city>
        <zip>930-0194</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Yamato-shi, Kanagawa</city>
        <zip>242-0004</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Gyeonggi-do</city>
        <zip>13620</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Seoul</city>
        <zip>06273</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Seoul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Seoul</city>
        <zip>06591</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Yangsan</city>
        <zip>626-770</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
    <country>Korea, Republic of</country>
  </location_countries>
  <results_reference>
    <citation>Davies M, Faerch L, Jeppesen OK, Pakseresht A, Pedersen SD, Perreault L, Rosenstock J, Shimomura I, Viljoen A, Wadden TA, Lingvay I; STEP 2 Study Group. Semaglutide 2.4 mg once a week in adults with overweight or obesity, and type 2 diabetes (STEP 2): a randomised, double-blind, double-dummy, placebo-controlled, phase 3 trial. Lancet. 2021 Mar 13;397(10278):971-984. doi: 10.1016/S0140-6736(21)00213-0. Epub 2021 Mar 2.</citation>
    <PMID>33667417</PMID>
  </results_reference>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <results_first_submitted>November 17, 2021</results_first_submitted>
  <results_first_submitted_qc>February 23, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">March 22, 2022</results_first_posted>
  <last_update_submitted>February 23, 2022</last_update_submitted>
  <last_update_submitted_qc>February 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>According to the Novo Nordisk disclosure commitment on novonordisk-trials.com</ipd_description>
    <ipd_url>https://www.novonordisk-trials.com</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 8, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/74/NCT03811574/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 19, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/74/NCT03811574/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The trial was conducted at 28 sites in 2 countries as follows (all sites screened and randomized):Japan (22 sites) and South korea (6 sites).</recruitment_details>
      <pre_assignment_details>The trial has a 68-week treatment period (12 weeks of dose escalation and 56 weeks of maintenance dose for 1.7 milligram (mg) once weekly arm and 16 weeks of dose escalation and 52 weeks of maintenance dose for 2.4 mg once weekly arm). Participants were randomised in 4:1:2:1 ratio to receive either semaglutide subcutaneously (s.c.) 2.4 mg once-weekly, semaglutide placebo once-weekly, semaglutide s.c. 1.7 mg once-weekly or semaglutide placebo once-weekly.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Semaglutide 1.7 mg</title>
          <description>Participants were to receive once-weekly s.c. injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 milliliter (mL) cartridge containing semaglutide 1.0 milligram per milliliter (mg/mL) or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), aiming at reaching the maintenance dose of 1.7 mg once-weekly after 12 weeks. Treatment was continued on the maintenance dose of 1.7 mg once-weekly for an additional 56 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
        </group>
        <group group_id="P2">
          <title>Semaglutide 2.4 mg</title>
          <description>Participants were to receive once-weekly s.c. injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg once-weekly after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
        </group>
        <group group_id="P3">
          <title>Placebo</title>
          <description>Participants were to receive once-weekly s.c. injection of placebo matched to semaglutide for 68 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="101"/>
                <participants group_id="P2" count="199"/>
                <participants group_id="P3" count="101"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Full Analysis Set (FAS)</title>
              <participants_list>
                <participants group_id="P1" count="101"/>
                <participants group_id="P2" count="199"/>
                <participants group_id="P3" count="101"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Analysis Set (SAS)</title>
              <participants_list>
                <participants group_id="P1" count="100"/>
                <participants group_id="P2" count="199"/>
                <participants group_id="P3" count="101"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="100"/>
                <participants group_id="P2" count="199"/>
                <participants group_id="P3" count="101"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="99"/>
                <participants group_id="P2" count="195"/>
                <participants group_id="P3" count="101"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Full analysis set (FAS) included all randomised participants.</population>
      <group_list>
        <group group_id="B1">
          <title>Semaglutide 1.7 mg</title>
          <description>Participants were to receive once-weekly s.c. injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), aiming at reaching the maintenance dose of 1.7 mg once-weekly after 12 weeks. Treatment was continued on the maintenance dose of 1.7 mg once-weekly for an additional 56 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
        </group>
        <group group_id="B2">
          <title>Semaglutide 2.4 mg</title>
          <description>Participants were to receive once-weekly s.c. injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg once-weekly after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
        </group>
        <group group_id="B3">
          <title>Placebo</title>
          <description>Participants were to receive once-weekly s.c. injection of placebo matched to semaglutide for 68 weeks.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="101"/>
            <count group_id="B2" value="199"/>
            <count group_id="B3" value="101"/>
            <count group_id="B4" value="401"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51" spread="10"/>
                    <measurement group_id="B2" value="52" spread="12"/>
                    <measurement group_id="B3" value="50" spread="9"/>
                    <measurement group_id="B4" value="51" spread="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="85"/>
                    <measurement group_id="B3" value="26"/>
                    <measurement group_id="B4" value="148"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                    <measurement group_id="B2" value="114"/>
                    <measurement group_id="B3" value="75"/>
                    <measurement group_id="B4" value="253"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="101"/>
                    <measurement group_id="B2" value="199"/>
                    <measurement group_id="B3" value="101"/>
                    <measurement group_id="B4" value="401"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="101"/>
                    <measurement group_id="B2" value="199"/>
                    <measurement group_id="B3" value="101"/>
                    <measurement group_id="B4" value="401"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Body Weight (%)</title>
        <description>Change from baseline (week 0) in body weight for 'in-trial' observation period at week 68 is presented. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact (week 75).</description>
        <time_frame>Baseline (week 0), week 68</time_frame>
        <population>FAS which comprised all randomised participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 1.7 mg</title>
            <description>Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), aiming at reaching the maintenance dose of 1.7 mg once-weekly after 12 weeks. Treatment was continued on the maintenance dose of 1.7 mg once-weekly for an additional 56 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 2.4 mg</title>
            <description>Participants were to receive once-weekly s.c. injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg once-weekly after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants were to receive once-weekly s.c. injection of placebo matched to semaglutide for 68 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Body Weight (%)</title>
          <description>Change from baseline (week 0) in body weight for 'in-trial' observation period at week 68 is presented. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact (week 75).</description>
          <population>FAS which comprised all randomised participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.</population>
          <units>Percentage change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="193"/>
                <count group_id="O3" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.9" spread="7.8"/>
                    <measurement group_id="O2" value="-13.4" spread="8.6"/>
                    <measurement group_id="O3" value="-1.9" spread="5.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Treatment policy estimand</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>ANCOVA</method>
            <param_type>Treatment difference</param_type>
            <param_value>-7.52</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.62</ci_lower_limit>
            <ci_upper_limit>-5.43</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Treatment policy estimand</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>ANCOVA</method>
            <param_type>Treatment difference</param_type>
            <param_value>-11.06</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12.88</ci_lower_limit>
            <ci_upper_limit>-9.24</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 5%</title>
        <description>Number of participants who achieved greater than or equal to (≥) 5% weight loss at week 68 for in-trial observation period is presented. In the reported data, 'Yes' infers the number of participants who have achieved ≥ 5% weight loss, whereas 'No' infers the number of participants who have not achieved ≥ 5% weight loss. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact (week 75).</description>
        <time_frame>At week 68</time_frame>
        <population>FAS which comprised all randomised participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 1.7 mg</title>
            <description>Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), aiming at reaching the maintenance dose of 1.7 mg once-weekly after 12 weeks. Treatment was continued on the maintenance dose of 1.7 mg once-weekly for an additional 56 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 2.4 mg</title>
            <description>Participants were to receive once-weekly s.c. injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg once-weekly after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants were to receive once-weekly s.c. injection of placebo matched to semaglutide for 68 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 5%</title>
          <description>Number of participants who achieved greater than or equal to (≥) 5% weight loss at week 68 for in-trial observation period is presented. In the reported data, 'Yes' infers the number of participants who have achieved ≥ 5% weight loss, whereas 'No' infers the number of participants who have not achieved ≥ 5% weight loss. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact (week 75).</description>
          <population>FAS which comprised all randomised participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="193"/>
                <count group_id="O3" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="71"/>
                    <measurement group_id="O2" value="160"/>
                    <measurement group_id="O3" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="33"/>
                    <measurement group_id="O3" value="79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Treatment policy estimand</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>11.08</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>5.53</ci_lower_limit>
            <ci_upper_limit>22.22</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Treatment policy estimand</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>21.72</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>11.27</ci_lower_limit>
            <ci_upper_limit>41.86</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 10%</title>
        <description>Number of participants who achieved greater than or equal to (≥) 10% weight loss at week 68 is presented. In the reported data, 'Yes' infers the number of participants who have achieved ≥ 10% weight loss, whereas 'No' infers the number of participants who have not achieved ≥ 10% weight loss. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
        <time_frame>At week 68</time_frame>
        <population>FAS which comprised all randomized participants. Overall number of participants analyzed = participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 1.7 mg</title>
            <description>Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), aiming at reaching the maintenance dose of 1.7 mg once-weekly after 12 weeks. Treatment was continued on the maintenance dose of 1.7 mg once-weekly for an additional 56 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 2.4 mg</title>
            <description>Participants were to receive once-weekly s.c. injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg once-weekly after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants were to receive once-weekly s.c. injection of placebo matched to semaglutide for 68 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 10%</title>
          <description>Number of participants who achieved greater than or equal to (≥) 10% weight loss at week 68 is presented. In the reported data, 'Yes' infers the number of participants who have achieved ≥ 10% weight loss, whereas 'No' infers the number of participants who have not achieved ≥ 10% weight loss. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
          <population>FAS which comprised all randomized participants. Overall number of participants analyzed = participants with available data.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="193"/>
                <count group_id="O3" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                    <measurement group_id="O2" value="117"/>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57"/>
                    <measurement group_id="O2" value="76"/>
                    <measurement group_id="O3" value="95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 15%</title>
        <description>Number of participants who achieved greater than or equal to (≥) 15% weight loss at week 68 is presented. In the reported data, 'Yes' infers the number of participants who have achieved ≥ 15% weight loss, whereas 'No' infers the number of participants who have not achieved ≥ 15% weight loss. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomization to last trial-related subject-site contact.</description>
        <time_frame>At week 68</time_frame>
        <population>FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 1.7 mg</title>
            <description>Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), aiming at reaching the maintenance dose of 1.7 mg once-weekly after 12 weeks. Treatment was continued on the maintenance dose of 1.7 mg once-weekly for an additional 56 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 2.4 mg</title>
            <description>Participants were to receive once-weekly s.c. injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg once-weekly after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants were to receive once-weekly s.c. injection of placebo matched to semaglutide for 68 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 15%</title>
          <description>Number of participants who achieved greater than or equal to (≥) 15% weight loss at week 68 is presented. In the reported data, 'Yes' infers the number of participants who have achieved ≥ 15% weight loss, whereas 'No' infers the number of participants who have not achieved ≥ 15% weight loss. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomization to last trial-related subject-site contact.</description>
          <population>FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="193"/>
                <count group_id="O3" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="79"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74"/>
                    <measurement group_id="O2" value="114"/>
                    <measurement group_id="O3" value="97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 20%</title>
        <description>Number of participants who achieved greater than or equal to (≥) 20% weight loss at week 68 is presented. In the reported data, 'Yes' infers the number of participants who have achieved ≥ 20% weight loss, whereas 'No' infers the number of participants who have not achieved ≥ 20% weight loss. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
        <time_frame>At week 68</time_frame>
        <population>FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 1.7 mg</title>
            <description>Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), aiming at reaching the maintenance dose of 1.7 mg once-weekly after 12 weeks. Treatment was continued on the maintenance dose of 1.7 mg once-weekly for an additional 56 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 2.4 mg</title>
            <description>Participants were to receive once-weekly s.c. injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg once-weekly after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants were to receive once-weekly s.c. injection of placebo matched to semaglutide for 68 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 20%</title>
          <description>Number of participants who achieved greater than or equal to (≥) 20% weight loss at week 68 is presented. In the reported data, 'Yes' infers the number of participants who have achieved ≥ 20% weight loss, whereas 'No' infers the number of participants who have not achieved ≥ 20% weight loss. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
          <population>FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="193"/>
                <count group_id="O3" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="38"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87"/>
                    <measurement group_id="O2" value="155"/>
                    <measurement group_id="O3" value="98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Waist Circumference Measured Midway Between the Lower Rib Margin and the Iliac Crest</title>
        <description>Change in waist circumference measured midway between the lower rib margin and the iliac crest from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
        <time_frame>Baseline (week 0) to week 68</time_frame>
        <population>FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 1.7 mg</title>
            <description>Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), aiming at reaching the maintenance dose of 1.7 mg once-weekly after 12 weeks. Treatment was continued on the maintenance dose of 1.7 mg once-weekly for an additional 56 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 2.4 mg</title>
            <description>Participants were to receive once-weekly s.c. injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg once-weekly after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants were to receive once-weekly s.c. injection of placebo matched to semaglutide for 68 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Waist Circumference Measured Midway Between the Lower Rib Margin and the Iliac Crest</title>
          <description>Change in waist circumference measured midway between the lower rib margin and the iliac crest from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
          <population>FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.</population>
          <units>Centimeter (cm)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="193"/>
                <count group_id="O3" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.8" spread="6.9"/>
                    <measurement group_id="O2" value="-11.2" spread="7.5"/>
                    <measurement group_id="O3" value="-1.8" spread="5.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Waist Circumference Measured According to the JASSO (Japan Society for the Study of Obesity) Guideline</title>
        <description>Change in Waist circumference measured according to the JASSO guideline from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
        <time_frame>Baseline (week 0) to week 68</time_frame>
        <population>FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 1.7 mg</title>
            <description>Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), aiming at reaching the maintenance dose of 1.7 mg once-weekly after 12 weeks. Treatment was continued on the maintenance dose of 1.7 mg once-weekly for an additional 56 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 2.4 mg</title>
            <description>Participants were to receive once-weekly s.c. injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg once-weekly after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants were to receive once-weekly s.c. injection of placebo matched to semaglutide for 68 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Waist Circumference Measured According to the JASSO (Japan Society for the Study of Obesity) Guideline</title>
          <description>Change in Waist circumference measured according to the JASSO guideline from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
          <population>FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.</population>
          <units>Centimeter (cm)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="193"/>
                <count group_id="O3" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.6" spread="5.7"/>
                    <measurement group_id="O2" value="-10.2" spread="6.8"/>
                    <measurement group_id="O3" value="-1.9" spread="5.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Body Weight (Kg)</title>
        <description>Change in body weight from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
        <time_frame>Baseline (week 0) to week 68</time_frame>
        <population>FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 1.7 mg</title>
            <description>Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), aiming at reaching the maintenance dose of 1.7 mg once-weekly after 12 weeks. Treatment was continued on the maintenance dose of 1.7 mg once-weekly for an additional 56 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 2.4 mg</title>
            <description>Participants were to receive once-weekly s.c. injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg once-weekly after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants were to receive once-weekly s.c. injection of placebo matched to semaglutide for 68 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Body Weight (Kg)</title>
          <description>Change in body weight from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
          <population>FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.</population>
          <units>Kilogram (kg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="193"/>
                <count group_id="O3" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.3" spread="6.1"/>
                    <measurement group_id="O2" value="-11.3" spread="7.3"/>
                    <measurement group_id="O3" value="-1.7" spread="5.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Body Mass Index (BMI)</title>
        <description>Change in BMI from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
        <time_frame>Baseline (week 0) to week 68</time_frame>
        <population>FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 1.7 mg</title>
            <description>Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), aiming at reaching the maintenance dose of 1.7 mg once-weekly after 12 weeks. Treatment was continued on the maintenance dose of 1.7 mg once-weekly for an additional 56 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 2.4 mg</title>
            <description>Participants were to receive once-weekly s.c. injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg once-weekly after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants were to receive once-weekly s.c. injection of placebo matched to semaglutide for 68 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Body Mass Index (BMI)</title>
          <description>Change in BMI from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
          <population>FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.</population>
          <units>Kilogram per square meter (kg/m^2)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="193"/>
                <count group_id="O3" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.1" spread="2.4"/>
                    <measurement group_id="O2" value="-4.3" spread="2.8"/>
                    <measurement group_id="O3" value="-0.6" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Visceral Fat Area (VFA) (%)</title>
        <description>Change in VFA from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
        <time_frame>Baseline (week 0) to week 68</time_frame>
        <population>CT scan subpopulation included all randomised participants who had a CT scan assessment. 'Overall Number of Participants Analyzed' = participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 1.7 mg</title>
            <description>Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), aiming at reaching the maintenance dose of 1.7 mg once-weekly after 12 weeks. Treatment was continued on the maintenance dose of 1.7 mg once-weekly for an additional 56 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 2.4 mg</title>
            <description>Participants were to receive once-weekly s.c. injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg once-weekly after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants were to receive once-weekly s.c. injection of placebo matched to semaglutide for 68 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Visceral Fat Area (VFA) (%)</title>
          <description>Change in VFA from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
          <population>CT scan subpopulation included all randomised participants who had a CT scan assessment. 'Overall Number of Participants Analyzed' = participants with available data.</population>
          <units>Percentage change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="86"/>
                <count group_id="O3" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-22.3" spread="31.3"/>
                    <measurement group_id="O2" value="-41.0" spread="23.3"/>
                    <measurement group_id="O3" value="-7.1" spread="19.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Visceral Fat Area (VFA) Centimeter Square (cm^2)</title>
        <description>Change in VFA from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
        <time_frame>Baseline (week 0) to week 68</time_frame>
        <population>CT scan subpopulation included all randomised participants who had a CT scan assessment. 'Overall Number of Participants Analyzed' = participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 1.7 mg</title>
            <description>Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), aiming at reaching the maintenance dose of 1.7 mg once-weekly after 12 weeks. Treatment was continued on the maintenance dose of 1.7 mg once-weekly for an additional 56 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 2.4 mg</title>
            <description>Participants were to receive once-weekly s.c. injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg once-weekly after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants were to receive once-weekly s.c. injection of placebo matched to semaglutide for 68 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Visceral Fat Area (VFA) Centimeter Square (cm^2)</title>
          <description>Change in VFA from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
          <population>CT scan subpopulation included all randomised participants who had a CT scan assessment. 'Overall Number of Participants Analyzed' = participants with available data.</population>
          <units>centimeter square (cm^2)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="86"/>
                <count group_id="O3" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-41.7" spread="47.0"/>
                    <measurement group_id="O2" value="-67.4" spread="43.0"/>
                    <measurement group_id="O3" value="-13.8" spread="38.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in HbA1c (%)</title>
        <description>Change in glycosylated haemoglobin (HbA1c) from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
        <time_frame>Baseline (week 0) to week 68</time_frame>
        <population>FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 1.7 mg</title>
            <description>Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), aiming at reaching the maintenance dose of 1.7 mg once-weekly after 12 weeks. Treatment was continued on the maintenance dose of 1.7 mg once-weekly for an additional 56 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 2.4 mg</title>
            <description>Participants were to receive once-weekly s.c. injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg once-weekly after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants were to receive once-weekly s.c. injection of placebo matched to semaglutide for 68 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in HbA1c (%)</title>
          <description>Change in glycosylated haemoglobin (HbA1c) from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
          <population>FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.</population>
          <units>Percentage of HbA1c</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="193"/>
                <count group_id="O3" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9" spread="0.8"/>
                    <measurement group_id="O2" value="-1.0" spread="1.0"/>
                    <measurement group_id="O3" value="0.0" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in HbA1c (mmol/Mol)</title>
        <description>Change in glycosylated haemoglobin (HbA1c) from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
        <time_frame>Baseline (week 0) to week 68</time_frame>
        <population>FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 1.7 mg</title>
            <description>Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), aiming at reaching the maintenance dose of 1.7 mg once-weekly after 12 weeks. Treatment was continued on the maintenance dose of 1.7 mg once-weekly for an additional 56 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 2.4 mg</title>
            <description>Participants were to receive once-weekly s.c. injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg once-weekly after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants were to receive once-weekly s.c. injection of placebo matched to semaglutide for 68 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in HbA1c (mmol/Mol)</title>
          <description>Change in glycosylated haemoglobin (HbA1c) from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
          <population>FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.</population>
          <units>millimoles per mole (mmol/mol)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="193"/>
                <count group_id="O3" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.9" spread="8.9"/>
                    <measurement group_id="O2" value="-10.6" spread="10.4"/>
                    <measurement group_id="O3" value="-0.1" spread="8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Fasting Plasma Glucose</title>
        <description>Change in fasting plasma glucose from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomization to last trial-related subject-site contact.</description>
        <time_frame>Baseline (week 0) to week 68</time_frame>
        <population>FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 1.7 mg</title>
            <description>Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), aiming at reaching the maintenance dose of 1.7 mg once-weekly after 12 weeks. Treatment was continued on the maintenance dose of 1.7 mg once-weekly for an additional 56 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 2.4 mg</title>
            <description>Participants were to receive once-weekly s.c. injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg once-weekly after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants were to receive once-weekly s.c. injection of placebo matched to semaglutide for 68 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Fasting Plasma Glucose</title>
          <description>Change in fasting plasma glucose from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomization to last trial-related subject-site contact.</description>
          <population>FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.</population>
          <units>Milligrams per deciliter (mg/dL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="97"/>
                <count group_id="O2" value="192"/>
                <count group_id="O3" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-18.3" spread="21.9"/>
                    <measurement group_id="O2" value="-19.3" spread="22.6"/>
                    <measurement group_id="O3" value="1.7" spread="26.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Fasting Serum Insulin-ratio to Baseline</title>
        <description>Change in fasting serum insulin measured as milli-international units per milliliter (mIU/mL) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
        <time_frame>Baseline (week 0) to week 68</time_frame>
        <population>FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 1.7 mg</title>
            <description>Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), aiming at reaching the maintenance dose of 1.7 mg once-weekly after 12 weeks. Treatment was continued on the maintenance dose of 1.7 mg once-weekly for an additional 56 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 2.4 mg</title>
            <description>Participants were to receive once-weekly s.c. injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg once-weekly after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants were to receive once-weekly s.c. injection of placebo matched to semaglutide for 68 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Fasting Serum Insulin-ratio to Baseline</title>
          <description>Change in fasting serum insulin measured as milli-international units per milliliter (mIU/mL) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
          <population>FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.</population>
          <units>Ratio of fasting serum insulin</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="97"/>
                <count group_id="O2" value="190"/>
                <count group_id="O3" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.85" spread="65"/>
                    <measurement group_id="O2" value="0.71" spread="57.7"/>
                    <measurement group_id="O3" value="0.89" spread="49.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Systolic Blood Pressure</title>
        <description>Change in systolic blood pressure from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
        <time_frame>Baseline (week 0) to week 68</time_frame>
        <population>FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 1.7 mg</title>
            <description>Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), aiming at reaching the maintenance dose of 1.7 mg once-weekly after 12 weeks. Treatment was continued on the maintenance dose of 1.7 mg once-weekly for an additional 56 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 2.4 mg</title>
            <description>Participants were to receive once-weekly s.c. injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg once-weekly after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants were to receive once-weekly s.c. injection of placebo matched to semaglutide for 68 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Systolic Blood Pressure</title>
          <description>Change in systolic blood pressure from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
          <population>FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.</population>
          <units>millimeters of mercury (mmHg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="193"/>
                <count group_id="O3" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12" spread="13"/>
                    <measurement group_id="O2" value="-11" spread="15"/>
                    <measurement group_id="O3" value="-5" spread="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Diastolic Blood Pressure</title>
        <description>Change in diastolic blood pressure from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
        <time_frame>Baseline (week 0) to week 68</time_frame>
        <population>FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 1.7 mg</title>
            <description>Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), aiming at reaching the maintenance dose of 1.7 mg once-weekly after 12 weeks. Treatment was continued on the maintenance dose of 1.7 mg once-weekly for an additional 56 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 2.4 mg</title>
            <description>Participants were to receive once-weekly s.c. injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg once-weekly after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants were to receive once-weekly s.c. injection of placebo matched to semaglutide for 68 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Diastolic Blood Pressure</title>
          <description>Change in diastolic blood pressure from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
          <population>FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="193"/>
                <count group_id="O3" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5" spread="10"/>
                    <measurement group_id="O2" value="-5" spread="10"/>
                    <measurement group_id="O3" value="-3" spread="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Total Cholesterol-ratio to Baseline</title>
        <description>Change in total cholesterol measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
        <time_frame>Baseline (week 0) to week 68</time_frame>
        <population>FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 1.7 mg</title>
            <description>Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), aiming at reaching the maintenance dose of 1.7 mg once-weekly after 12 weeks. Treatment was continued on the maintenance dose of 1.7 mg once-weekly for an additional 56 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 2.4 mg</title>
            <description>Participants were to receive once-weekly s.c. injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg once-weekly after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants were to receive once-weekly s.c. injection of placebo matched to semaglutide for 68 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Total Cholesterol-ratio to Baseline</title>
          <description>Change in total cholesterol measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
          <population>FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.</population>
          <units>Ratio of total cholesterol</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="193"/>
                <count group_id="O3" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.93" spread="16.5"/>
                    <measurement group_id="O2" value="0.91" spread="13.3"/>
                    <measurement group_id="O3" value="1.00" spread="12.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in High-density Lipoproteins (HDL)-Ratio to Baseline</title>
        <description>Change in HDL measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
        <time_frame>Baseline (week 0) to week 68</time_frame>
        <population>FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 1.7 mg</title>
            <description>Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), aiming at reaching the maintenance dose of 1.7 mg once-weekly after 12 weeks. Treatment was continued on the maintenance dose of 1.7 mg once-weekly for an additional 56 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 2.4 mg</title>
            <description>Participants were to receive once-weekly s.c. injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg once-weekly after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants were to receive once-weekly s.c. injection of placebo matched to semaglutide for 68 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in High-density Lipoproteins (HDL)-Ratio to Baseline</title>
          <description>Change in HDL measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
          <population>FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.</population>
          <units>Ratio of high-density lipoproteins</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="193"/>
                <count group_id="O3" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.06" spread="17.3"/>
                    <measurement group_id="O2" value="1.08" spread="13.7"/>
                    <measurement group_id="O3" value="1.06" spread="12.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Low-density Lipoproteins (LDL)-Ratio to Baseline</title>
        <description>Change in LDL measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomization to last trial-related subject-site contact.</description>
        <time_frame>Baseline (week 0) to week 68</time_frame>
        <population>FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 1.7 mg</title>
            <description>Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), aiming at reaching the maintenance dose of 1.7 mg once-weekly after 12 weeks. Treatment was continued on the maintenance dose of 1.7 mg once-weekly for an additional 56 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 2.4 mg</title>
            <description>Participants were to receive once-weekly s.c. injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg once-weekly after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants were to receive once-weekly s.c. injection of placebo matched to semaglutide for 68 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Low-density Lipoproteins (LDL)-Ratio to Baseline</title>
          <description>Change in LDL measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomization to last trial-related subject-site contact.</description>
          <population>FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.</population>
          <units>Ratio of low-density lipoproteins</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="193"/>
                <count group_id="O3" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.90" spread="25.2"/>
                    <measurement group_id="O2" value="0.86" spread="23.5"/>
                    <measurement group_id="O3" value="0.95" spread="21.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Very Low-density Lipoproteins (VLDL)-Ratio to Baseline</title>
        <description>Change in VLDL measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomization to last trial-related subject-site contact.</description>
        <time_frame>Baseline (week 0) to week 68</time_frame>
        <population>FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 1.7 mg</title>
            <description>Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), aiming at reaching the maintenance dose of 1.7 mg once-weekly after 12 weeks. Treatment was continued on the maintenance dose of 1.7 mg once-weekly for an additional 56 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 2.4 mg</title>
            <description>Participants were to receive once-weekly s.c. injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg once-weekly after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants were to receive once-weekly s.c. injection of placebo matched to semaglutide for 68 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Very Low-density Lipoproteins (VLDL)-Ratio to Baseline</title>
          <description>Change in VLDL measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomization to last trial-related subject-site contact.</description>
          <population>FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.</population>
          <units>Ratio of very low-density lipoproteins</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="193"/>
                <count group_id="O3" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.79" spread="43.2"/>
                    <measurement group_id="O2" value="0.79" spread="43.2"/>
                    <measurement group_id="O3" value="1.05" spread="41.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Free Fatty Acids-ratio to Baseline</title>
        <description>Change in free fatty acids measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
        <time_frame>Baseline (week 0) to week 68</time_frame>
        <population>FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 1.7 mg</title>
            <description>Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), aiming at reaching the maintenance dose of 1.7 mg once-weekly after 12 weeks. Treatment was continued on the maintenance dose of 1.7 mg once-weekly for an additional 56 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 2.4 mg</title>
            <description>Participants were to receive once-weekly s.c. injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg once-weekly after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants were to receive once-weekly s.c. injection of placebo matched to semaglutide for 68 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Free Fatty Acids-ratio to Baseline</title>
          <description>Change in free fatty acids measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
          <population>FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.</population>
          <units>Ratio of free fatty acids</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="97"/>
                <count group_id="O2" value="190"/>
                <count group_id="O3" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.04" spread="57.7"/>
                    <measurement group_id="O2" value="0.96" spread="59.1"/>
                    <measurement group_id="O3" value="1.28" spread="52.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Triglycerides-ratio to Baseline</title>
        <description>Change in triglycerides measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
        <time_frame>Baseline (week 0) to week 68</time_frame>
        <population>FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 1.7 mg</title>
            <description>Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), aiming at reaching the maintenance dose of 1.7 mg once-weekly after 12 weeks. Treatment was continued on the maintenance dose of 1.7 mg once-weekly for an additional 56 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 2.4 mg</title>
            <description>Participants were to receive once-weekly s.c. injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg once-weekly after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants were to receive once-weekly s.c. injection of placebo matched to semaglutide for 68 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Triglycerides-ratio to Baseline</title>
          <description>Change in triglycerides measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
          <population>FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.</population>
          <units>Ratio of triglycerides</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="193"/>
                <count group_id="O3" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.78" spread="49.8"/>
                    <measurement group_id="O2" value="0.79" spread="43.8"/>
                    <measurement group_id="O3" value="1.05" spread="41.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in High Sensitivity C-reactive Protein (hsCRP)-Ratio to Baseline</title>
        <description>Change in hsCRP measured in milligram per ilitre (mg/L) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
        <time_frame>Baseline (week 0) to week 68</time_frame>
        <population>FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 1.7 mg</title>
            <description>Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), aiming at reaching the maintenance dose of 1.7 mg once-weekly after 12 weeks. Treatment was continued on the maintenance dose of 1.7 mg once-weekly for an additional 56 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 2.4 mg</title>
            <description>Participants were to receive once-weekly s.c. injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg once-weekly after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants were to receive once-weekly s.c. injection of placebo matched to semaglutide for 68 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in High Sensitivity C-reactive Protein (hsCRP)-Ratio to Baseline</title>
          <description>Change in hsCRP measured in milligram per ilitre (mg/L) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
          <population>FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.</population>
          <units>Ratio of hsCRP</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="193"/>
                <count group_id="O3" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.64" spread="218.3"/>
                    <measurement group_id="O2" value="0.39" spread="119.3"/>
                    <measurement group_id="O3" value="0.92" spread="123"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Plasminogen Activator Inhibitor-1 Activity-ratio to Baseline</title>
        <description>Change in plasminogen activator inhibitor-1 (PAI-1) activity measured in arbritary units per milliliter (AU/ml) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
        <time_frame>Baseline (week 0) to week 68</time_frame>
        <population>FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 1.7 mg</title>
            <description>Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), aiming at reaching the maintenance dose of 1.7 mg once-weekly after 12 weeks. Treatment was continued on the maintenance dose of 1.7 mg once-weekly for an additional 56 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 2.4 mg</title>
            <description>Participants were to receive once-weekly s.c. injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg once-weekly after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants were to receive once-weekly s.c. injection of placebo matched to semaglutide for 68 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Plasminogen Activator Inhibitor-1 Activity-ratio to Baseline</title>
          <description>Change in plasminogen activator inhibitor-1 (PAI-1) activity measured in arbritary units per milliliter (AU/ml) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
          <population>FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.</population>
          <units>Ratio of PAI-1 activity</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="97"/>
                <count group_id="O2" value="190"/>
                <count group_id="O3" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.83" spread="75.8"/>
                    <measurement group_id="O2" value="0.68" spread="62"/>
                    <measurement group_id="O3" value="1" spread="51.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Short Form 36 v2.0 Acute (SF-36) Score</title>
        <description>SF-36 is a 36-item patient-reported survey of patient health that measures participant's overall health-related quality of life (HRQoL). SF-36v2™ questionnaire measured eight domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). This endpoint shows results for all the domains. The 0-100 scale scores from SF-36 were converted to norm-based scores to enable a direct interpretation in relation to distribution of scores in the 2009 U.S. general population. In metric of norm-based scores, 50 and 10 corresponds to mean and standard deviation respectively. Change from week 0 in domain scores and component summary scores were evaluated at week 68. A positive change score indicates an improvement since baseline. These endpoints were evaluated based on data from in-trial observation period which is uninterrupted time interval from randomisation to last contact with trial site.</description>
        <time_frame>Baseline (week 0) to week 68</time_frame>
        <population>FAS included all randomised participants. Overall Number of Participants Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 1.7 mg</title>
            <description>Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), aiming at reaching the maintenance dose of 1.7 mg once-weekly after 12 weeks. Treatment was continued on the maintenance dose of 1.7 mg once-weekly for an additional 56 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 2.4 mg</title>
            <description>Participants were to receive once-weekly s.c. injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg once-weekly after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants were to receive once-weekly s.c. injection of placebo matched to semaglutide for 68 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Short Form 36 v2.0 Acute (SF-36) Score</title>
          <description>SF-36 is a 36-item patient-reported survey of patient health that measures participant's overall health-related quality of life (HRQoL). SF-36v2™ questionnaire measured eight domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). This endpoint shows results for all the domains. The 0-100 scale scores from SF-36 were converted to norm-based scores to enable a direct interpretation in relation to distribution of scores in the 2009 U.S. general population. In metric of norm-based scores, 50 and 10 corresponds to mean and standard deviation respectively. Change from week 0 in domain scores and component summary scores were evaluated at week 68. A positive change score indicates an improvement since baseline. These endpoints were evaluated based on data from in-trial observation period which is uninterrupted time interval from randomisation to last contact with trial site.</description>
          <population>FAS included all randomised participants. Overall Number of Participants Analyzed = number of participants with available data.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="192"/>
                <count group_id="O3" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change in SF-36:Physical functioning score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="5.7"/>
                    <measurement group_id="O2" value="1.0" spread="3.7"/>
                    <measurement group_id="O3" value="-0.5" spread="3.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change in SF-36: Role-Physical score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.6" spread="5.2"/>
                    <measurement group_id="O2" value="-0.2" spread="4.7"/>
                    <measurement group_id="O3" value="0.3" spread="5.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change in SF-36: Bodily Pain score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.8" spread="9.2"/>
                    <measurement group_id="O2" value="-1.1" spread="7.5"/>
                    <measurement group_id="O3" value="-0.2" spread="8.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change in SF-36: General Health score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.4" spread="5.4"/>
                    <measurement group_id="O2" value="0.4" spread="5.8"/>
                    <measurement group_id="O3" value="-0.6" spread="5.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change in SF-36: Vitality score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.4" spread="7.8"/>
                    <measurement group_id="O2" value="-1.5" spread="6.8"/>
                    <measurement group_id="O3" value="-0.9" spread="7.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change in SF-36: Social Functioning score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" spread="3.8"/>
                    <measurement group_id="O2" value="-0.9" spread="6.2"/>
                    <measurement group_id="O3" value="0.3" spread="5.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change in SF-36: Role-Emotional score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.6" spread="5.6"/>
                    <measurement group_id="O2" value="-1.1" spread="5.5"/>
                    <measurement group_id="O3" value="-0.9" spread="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change in SF-36: Mental Health score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.9" spread="7.2"/>
                    <measurement group_id="O2" value="-1.5" spread="6.7"/>
                    <measurement group_id="O3" value="-1.2" spread="5.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change in SF-36: Physical component summary</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" spread="6.0"/>
                    <measurement group_id="O2" value="0.7" spread="4.4"/>
                    <measurement group_id="O3" value="0.1" spread="5.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change in SF-36: Mental component summary</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.0" spread="6.4"/>
                    <measurement group_id="O2" value="-1.9" spread="6.4"/>
                    <measurement group_id="O3" value="-1.0" spread="4.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Impact of Weight on Quality of Life-lite for Clinical Trials (IWQOL-Lite for CT) Score</title>
        <description>The Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite-CT) is designed to assess the impact of changes in weight on patients' quality of life within the context of clinical trials. IWQOL-Lite-CT is a 20-item questionnaire-based instrument used to assess the impact of body weight changes on participant's overall health-related quality of life (HRQoL). All IWQOL-Lite-CT composite scores range from 0 to 100, with higher scores reflecting better levels of functioning. This endpoint shows results for 'physical function score' physical and psychosocial domains, and for total'. The endpoint was evaluated based on the data from in-trial observation period which is the uninterrupted time interval from randomisation to last contact with trial site.</description>
        <time_frame>Baseline (week 0) to week 68</time_frame>
        <population>FAS included all randomised participants. Overall Number of Participants Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 1.7 mg</title>
            <description>Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), aiming at reaching the maintenance dose of 1.7 mg once-weekly after 12 weeks. Treatment was continued on the maintenance dose of 1.7 mg once-weekly for an additional 56 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 2.4 mg</title>
            <description>Participants were to receive once-weekly s.c. injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg once-weekly after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants were to receive once-weekly s.c. injection of placebo matched to semaglutide for 68 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Impact of Weight on Quality of Life-lite for Clinical Trials (IWQOL-Lite for CT) Score</title>
          <description>The Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite-CT) is designed to assess the impact of changes in weight on patients' quality of life within the context of clinical trials. IWQOL-Lite-CT is a 20-item questionnaire-based instrument used to assess the impact of body weight changes on participant's overall health-related quality of life (HRQoL). All IWQOL-Lite-CT composite scores range from 0 to 100, with higher scores reflecting better levels of functioning. This endpoint shows results for 'physical function score' physical and psychosocial domains, and for total'. The endpoint was evaluated based on the data from in-trial observation period which is the uninterrupted time interval from randomisation to last contact with trial site.</description>
          <population>FAS included all randomised participants. Overall Number of Participants Analyzed = number of participants with available data.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="192"/>
                <count group_id="O3" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Physical function score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" spread="16.3"/>
                    <measurement group_id="O2" value="4.9" spread="15.1"/>
                    <measurement group_id="O3" value="0.5" spread="12.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" spread="14.3"/>
                    <measurement group_id="O2" value="4.2" spread="14.4"/>
                    <measurement group_id="O3" value="-0.8" spread="11.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Psychosocial</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.4" spread="11.9"/>
                    <measurement group_id="O2" value="5.2" spread="12.7"/>
                    <measurement group_id="O3" value="-0.3" spread="12.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5" spread="11.0"/>
                    <measurement group_id="O2" value="4.8" spread="11.8"/>
                    <measurement group_id="O3" value="-0.5" spread="10.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Achieve (Yes/no): Responder Definition Value for SF-36 Physical Functioning Score</title>
        <description>The number of participants experiencing a meaningful within participant improvement in SF-36 Physical function after 68 weeks was determined based on 3.7 threshold. The threshold of 3.7 is specific for overweight or obese population included in the study and calculated using patient global rating anchor questionnaires to reflect participants' own perspective based on Food and Drug Administration (FDA) recommendations. In the reported data, &quot;Yes&quot; infers the number of participants who have achieved an improvement in score greater than or equal to the threshold and &quot;No&quot; infers number of participants who have not achieved an improvement in score greater than or equal to the threshold. The endpoint was evaluated based on in-trial observation period which is the uninterrupted time interval from randomisation to last contact with trial site.</description>
        <time_frame>At week 68</time_frame>
        <population>FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 1.7 mg</title>
            <description>Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), aiming at reaching the maintenance dose of 1.7 mg once-weekly after 12 weeks. Treatment was continued on the maintenance dose of 1.7 mg once-weekly for an additional 56 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 2.4 mg</title>
            <description>Participants were to receive once-weekly s.c. injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg once-weekly after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants were to receive once-weekly s.c. injection of placebo matched to semaglutide for 68 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Achieve (Yes/no): Responder Definition Value for SF-36 Physical Functioning Score</title>
          <description>The number of participants experiencing a meaningful within participant improvement in SF-36 Physical function after 68 weeks was determined based on 3.7 threshold. The threshold of 3.7 is specific for overweight or obese population included in the study and calculated using patient global rating anchor questionnaires to reflect participants' own perspective based on Food and Drug Administration (FDA) recommendations. In the reported data, &quot;Yes&quot; infers the number of participants who have achieved an improvement in score greater than or equal to the threshold and &quot;No&quot; infers number of participants who have not achieved an improvement in score greater than or equal to the threshold. The endpoint was evaluated based on in-trial observation period which is the uninterrupted time interval from randomisation to last contact with trial site.</description>
          <population>FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="192"/>
                <count group_id="O3" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="43"/>
                    <measurement group_id="O3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79"/>
                    <measurement group_id="O2" value="149"/>
                    <measurement group_id="O3" value="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Achieve (Yes/no): Responder Definition Value for IWQoL-Lite for CT Physical Function (5-items) Score</title>
        <description>The number of participants experiencing a meaningful within participant improvement in IWQOL-Lite-CT physical function after 68 weeks was determined based on thresholds of 14.6. The threshold of 14.6 is specific for the population with overweight or obesity included in the study and calculated using patient global rating anchor questionnaires to reflect participants' own perspective based on FDA recommendations. In the reported data, &quot;Yes&quot; infers the number of participants who have achieved an improvement in score greater than or equal to the threshold and &quot;No&quot; infers the number of participants who have not achieved an improvement in score greater than or equal to the threshold. The endpoint was evaluated based on in-trial observation period which is the uninterrupted time interval from randomisation to last contact with trial site.</description>
        <time_frame>At week 68</time_frame>
        <population>FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 1.7 mg</title>
            <description>Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), aiming at reaching the maintenance dose of 1.7 mg once-weekly after 12 weeks. Treatment was continued on the maintenance dose of 1.7 mg once-weekly for an additional 56 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 2.4 mg</title>
            <description>Participants were to receive once-weekly s.c. injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg once-weekly after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants were to receive once-weekly s.c. injection of placebo matched to semaglutide for 68 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Achieve (Yes/no): Responder Definition Value for IWQoL-Lite for CT Physical Function (5-items) Score</title>
          <description>The number of participants experiencing a meaningful within participant improvement in IWQOL-Lite-CT physical function after 68 weeks was determined based on thresholds of 14.6. The threshold of 14.6 is specific for the population with overweight or obesity included in the study and calculated using patient global rating anchor questionnaires to reflect participants' own perspective based on FDA recommendations. In the reported data, &quot;Yes&quot; infers the number of participants who have achieved an improvement in score greater than or equal to the threshold and &quot;No&quot; infers the number of participants who have not achieved an improvement in score greater than or equal to the threshold. The endpoint was evaluated based on in-trial observation period which is the uninterrupted time interval from randomisation to last contact with trial site.</description>
          <population>FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="192"/>
                <count group_id="O3" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="49"/>
                    <measurement group_id="O3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79"/>
                    <measurement group_id="O2" value="143"/>
                    <measurement group_id="O3" value="89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Achieved (Yes/no): HbA1c &lt;7.0% (53 mmol/Mol)</title>
        <description>Number of participants who achieved HbA1c &lt;7% (53 mmol/mol) at week 68 is presented. In the reported data, &quot;Yes&quot; infers the number of participants who have achieved HbA1c values less than the 7% and &quot;No&quot; infers the number of participants who have not achieved HbA1c values less than the 7%. The endpoint was evaluated based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
        <time_frame>At week 68</time_frame>
        <population>FAS included all randomised participants. Overall Number of Participants Analyzed = participants with type 2 diabetes at screening with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 1.7 mg</title>
            <description>Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), aiming at reaching the maintenance dose of 1.7 mg once-weekly after 12 weeks. Treatment was continued on the maintenance dose of 1.7 mg once-weekly for an additional 56 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 2.4 mg</title>
            <description>Participants were to receive once-weekly s.c. injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg once-weekly after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants were to receive once-weekly s.c. injection of placebo matched to semaglutide for 68 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Achieved (Yes/no): HbA1c &lt;7.0% (53 mmol/Mol)</title>
          <description>Number of participants who achieved HbA1c &lt;7% (53 mmol/mol) at week 68 is presented. In the reported data, &quot;Yes&quot; infers the number of participants who have achieved HbA1c values less than the 7% and &quot;No&quot; infers the number of participants who have not achieved HbA1c values less than the 7%. The endpoint was evaluated based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
          <population>FAS included all randomised participants. Overall Number of Participants Analyzed = participants with type 2 diabetes at screening with available data.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="49"/>
                <count group_id="O3" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="43"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Achieved (Yes/no): HbA1c ≤6.5% (48 mmol/Mol)</title>
        <description>Number of participants who achieved HbA1c ≤6.5% (48 mmol/mol) at week 68 is presented. In the reported data, &quot;Yes&quot; infers the number of participants who have achieved HbA1c values less than or equal to 6.5% and &quot;No&quot; infers the number of participants who have not achieved HbA1c values less than or equal to 6.5%. The endpoint was evaluated based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
        <time_frame>At week 68</time_frame>
        <population>FAS included all randomised participants. Overall Number of Participants Analyzed = participants with type 2 diabetes at screening with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 1.7 mg</title>
            <description>Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), aiming at reaching the maintenance dose of 1.7 mg once-weekly after 12 weeks. Treatment was continued on the maintenance dose of 1.7 mg once-weekly for an additional 56 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 2.4 mg</title>
            <description>Participants were to receive once-weekly s.c. injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg once-weekly after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants were to receive once-weekly s.c. injection of placebo matched to semaglutide for 68 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Achieved (Yes/no): HbA1c ≤6.5% (48 mmol/Mol)</title>
          <description>Number of participants who achieved HbA1c ≤6.5% (48 mmol/mol) at week 68 is presented. In the reported data, &quot;Yes&quot; infers the number of participants who have achieved HbA1c values less than or equal to 6.5% and &quot;No&quot; infers the number of participants who have not achieved HbA1c values less than or equal to 6.5%. The endpoint was evaluated based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.</description>
          <population>FAS included all randomised participants. Overall Number of Participants Analyzed = participants with type 2 diabetes at screening with available data.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="49"/>
                <count group_id="O3" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="40"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Treatment-emergent AEs</title>
        <description>An adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. All AEs mentioned here are treatment emergent adverse events (TEAE) defined as an event with onset during the on-treatment observation period. On-treatment observation period: the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.</description>
        <time_frame>Week 0 to week 75</time_frame>
        <population>Safety analysis set (SAS) included all randomised participants exposed to at least one dose of randomised treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 1.7 mg</title>
            <description>Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), aiming at reaching the maintenance dose of 1.7 mg once-weekly after 12 weeks. Treatment was continued on the maintenance dose of 1.7 mg once-weekly for an additional 56 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 2.4 mg</title>
            <description>Participants were to receive once-weekly s.c. injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg once-weekly after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants were to receive once-weekly s.c. injection of placebo matched to semaglutide for 68 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Treatment-emergent AEs</title>
          <description>An adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. All AEs mentioned here are treatment emergent adverse events (TEAE) defined as an event with onset during the on-treatment observation period. On-treatment observation period: the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.</description>
          <population>Safety analysis set (SAS) included all randomised participants exposed to at least one dose of randomised treatment.</population>
          <units>Events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="199"/>
                <count group_id="O3" value="101"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="483"/>
                    <measurement group_id="O2" value="834"/>
                    <measurement group_id="O3" value="235"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Serious Adverse Events</title>
        <description>A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. SAE results occurred from week 0 to week 75 is presented based on the on-treatment observation, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.</description>
        <time_frame>Week 0 to week 75</time_frame>
        <population>Safety analysis set (SAS) included all randomised participants exposed to at least one dose of randomised treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 1.7 mg</title>
            <description>Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), aiming at reaching the maintenance dose of 1.7 mg once-weekly after 12 weeks. Treatment was continued on the maintenance dose of 1.7 mg once-weekly for an additional 56 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 2.4 mg</title>
            <description>Participants were to receive once-weekly s.c. injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg once-weekly after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants were to receive once-weekly s.c. injection of placebo matched to semaglutide for 68 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Serious Adverse Events</title>
          <description>A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. SAE results occurred from week 0 to week 75 is presented based on the on-treatment observation, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.</description>
          <population>Safety analysis set (SAS) included all randomised participants exposed to at least one dose of randomised treatment.</population>
          <units>Events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="199"/>
                <count group_id="O3" value="101"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes</title>
        <description>Hypoglycaemic episodes with onset during on-treatment observation period were considered treatment-emergent. Number of treatment emergent severe or BG confirmed symptomatic hypoglycaemia episodes with onset during on-treatment observation period were presented. Severe hypoglycaemia: episode requiring assistance of another person to administer carbohydrate, glucagon or take other corrective actions. plasma glucose (PG) concentrations may not be available during an event, but neurological recovery following return of PG to normal is considered sufficient evidence that event was induced by low PG concentration. BG confirmed symptomatic hypoglycaemia: episode that is BG confirmed by PG value &lt;3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. On-treatment observation period is interval from date of first trial product administration (week 0) to date of last trial product administration (week 68) plus 7-week follow-up period and excluding any off-treatment time intervals.</description>
        <time_frame>Week 0 to week 75</time_frame>
        <population>Safety analysis set (SAS) included all randomised participants exposed to at least one dose of randomised treatment. Overall number of participants analyzed = participants with type 2 diabetes at screening.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 1.7 mg</title>
            <description>Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), aiming at reaching the maintenance dose of 1.7 mg once-weekly after 12 weeks. Treatment was continued on the maintenance dose of 1.7 mg once-weekly for an additional 56 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 2.4 mg</title>
            <description>Participants were to receive once-weekly s.c. injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg once-weekly after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants were to receive once-weekly s.c. injection of placebo matched to semaglutide for 68 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes</title>
          <description>Hypoglycaemic episodes with onset during on-treatment observation period were considered treatment-emergent. Number of treatment emergent severe or BG confirmed symptomatic hypoglycaemia episodes with onset during on-treatment observation period were presented. Severe hypoglycaemia: episode requiring assistance of another person to administer carbohydrate, glucagon or take other corrective actions. plasma glucose (PG) concentrations may not be available during an event, but neurological recovery following return of PG to normal is considered sufficient evidence that event was induced by low PG concentration. BG confirmed symptomatic hypoglycaemia: episode that is BG confirmed by PG value &lt;3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. On-treatment observation period is interval from date of first trial product administration (week 0) to date of last trial product administration (week 68) plus 7-week follow-up period and excluding any off-treatment time intervals.</description>
          <population>Safety analysis set (SAS) included all randomised participants exposed to at least one dose of randomised treatment. Overall number of participants analyzed = participants with type 2 diabetes at screening.</population>
          <units>Episodes</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="49"/>
                <count group_id="O3" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Pulse</title>
        <description>Change in pulse from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals.</description>
        <time_frame>Baseline (week 0) to week 68</time_frame>
        <population>SAS included all randomised participants exposed to at least one dose of randomised treatment. 'Overall Number of Participants Analysed' = participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 1.7 mg</title>
            <description>Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), aiming at reaching the maintenance dose of 1.7 mg once-weekly after 12 weeks. Treatment was continued on the maintenance dose of 1.7 mg once-weekly for an additional 56 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 2.4 mg</title>
            <description>Participants were to receive once-weekly s.c. injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg once-weekly after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants were to receive once-weekly s.c. injection of placebo matched to semaglutide for 68 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Pulse</title>
          <description>Change in pulse from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals.</description>
          <population>SAS included all randomised participants exposed to at least one dose of randomised treatment. 'Overall Number of Participants Analysed' = participants with available data.</population>
          <units>Beats/minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="93"/>
                <count group_id="O2" value="186"/>
                <count group_id="O3" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6" spread="10"/>
                    <measurement group_id="O2" value="4" spread="9"/>
                    <measurement group_id="O3" value="2" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Amylase: Ratio to Baseline</title>
        <description>Change in amylase measured in units/liter (U/L) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals.</description>
        <time_frame>Baseline (week 0) to week 68</time_frame>
        <population>SAS included all randomised participants exposed to at least one dose of randomised treatment. 'Overall Number of Participants Analysed' = participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 1.7 mg</title>
            <description>Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), aiming at reaching the maintenance dose of 1.7 mg once-weekly after 12 weeks. Treatment was continued on the maintenance dose of 1.7 mg once-weekly for an additional 56 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 2.4 mg</title>
            <description>Participants were to receive once-weekly s.c. injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg once-weekly after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants were to receive once-weekly s.c. injection of placebo matched to semaglutide for 68 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Amylase: Ratio to Baseline</title>
          <description>Change in amylase measured in units/liter (U/L) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals.</description>
          <population>SAS included all randomised participants exposed to at least one dose of randomised treatment. 'Overall Number of Participants Analysed' = participants with available data.</population>
          <units>Ratio of amylase</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="93"/>
                <count group_id="O2" value="186"/>
                <count group_id="O3" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.09" spread="20.9"/>
                    <measurement group_id="O2" value="1.08" spread="23.2"/>
                    <measurement group_id="O3" value="0.93" spread="25.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Lipase: Ratio to Baseline</title>
        <description>Change in lipase measured in units/litre (U/L) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals.</description>
        <time_frame>Baseline (week 0) to week 68</time_frame>
        <population>SAS included all randomised participants exposed to at least one dose of randomised treatment. 'Overall Number of Participants Analysed' = participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 1.7 mg</title>
            <description>Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), aiming at reaching the maintenance dose of 1.7 mg once-weekly after 12 weeks. Treatment was continued on the maintenance dose of 1.7 mg once-weekly for an additional 56 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 2.4 mg</title>
            <description>Participants were to receive once-weekly s.c. injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg once-weekly after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants were to receive once-weekly s.c. injection of placebo matched to semaglutide for 68 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Lipase: Ratio to Baseline</title>
          <description>Change in lipase measured in units/litre (U/L) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals.</description>
          <population>SAS included all randomised participants exposed to at least one dose of randomised treatment. 'Overall Number of Participants Analysed' = participants with available data.</population>
          <units>Ratio of lipase</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="93"/>
                <count group_id="O2" value="186"/>
                <count group_id="O3" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.56" spread="39.8"/>
                    <measurement group_id="O2" value="1.56" spread="45.4"/>
                    <measurement group_id="O3" value="0.96" spread="40.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Calcitonin: Ratio to Baseline</title>
        <description>Change in calcitonin measured in nanogram/litre (ng/L) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals.</description>
        <time_frame>Baseline (week 0) to week 68</time_frame>
        <population>SAS included all randomised participants exposed to at least one dose of randomised treatment. 'Overall Number of Participants Analysed' = participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 1.7 mg</title>
            <description>Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), aiming at reaching the maintenance dose of 1.7 mg once-weekly after 12 weeks. Treatment was continued on the maintenance dose of 1.7 mg once-weekly for an additional 56 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 2.4 mg</title>
            <description>Participants were to receive once-weekly s.c. injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg once-weekly after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants were to receive once-weekly s.c. injection of placebo matched to semaglutide for 68 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Calcitonin: Ratio to Baseline</title>
          <description>Change in calcitonin measured in nanogram/litre (ng/L) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals.</description>
          <population>SAS included all randomised participants exposed to at least one dose of randomised treatment. 'Overall Number of Participants Analysed' = participants with available data.</population>
          <units>Ratio of calcitonin</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="93"/>
                <count group_id="O2" value="186"/>
                <count group_id="O3" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.98" spread="32.4"/>
                    <measurement group_id="O2" value="0.95" spread="34.6"/>
                    <measurement group_id="O3" value="0.94" spread="30.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in QTCF Interval</title>
        <description>Change in QTCF Interval from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals.</description>
        <time_frame>Baseline (week 0) to week 68</time_frame>
        <population>SAS included all randomised participants exposed to at least one dose of randomised treatment. 'Overall Number of Participants Analysed' = participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 1.7 mg</title>
            <description>Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), aiming at reaching the maintenance dose of 1.7 mg once-weekly after 12 weeks. Treatment was continued on the maintenance dose of 1.7 mg once-weekly for an additional 56 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 2.4 mg</title>
            <description>Participants were to receive once-weekly s.c. injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg once-weekly after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants were to receive once-weekly s.c. injection of placebo matched to semaglutide for 68 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in QTCF Interval</title>
          <description>Change in QTCF Interval from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals.</description>
          <population>SAS included all randomised participants exposed to at least one dose of randomised treatment. 'Overall Number of Participants Analysed' = participants with available data.</population>
          <units>millisecond (msec)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="92"/>
                <count group_id="O2" value="186"/>
                <count group_id="O3" value="96"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.2" spread="17.8"/>
                    <measurement group_id="O2" value="-2.5" spread="15.2"/>
                    <measurement group_id="O3" value="5.6" spread="14.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Week 0 to week 75.</time_frame>
      <desc>All presented AEs are treatment-emergent (i.e., TEAEs). Adverse events were defined as &quot;treatment-emergent&quot; (TEAE), if the onset of the event occurs in the on-treatment period. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment.</desc>
      <group_list>
        <group group_id="E1">
          <title>Semaglutide 1.7 mg</title>
          <description>Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), aiming at reaching the maintenance dose of 1.7 mg once-weekly after 12 weeks. Treatment was continued on the maintenance dose of 1.7 mg once-weekly for an additional 56 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
        </group>
        <group group_id="E2">
          <title>Semaglutide 2.4 mg</title>
          <description>Participants were to receive once-weekly s.c. injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg once-weekly after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.</description>
        </group>
        <group group_id="E3">
          <title>Placebo</title>
          <description>Participants were to receive once-weekly s.c. injection of placebo matched to semaglutide for 68 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 23</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="199"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="199"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Lymphadenitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="199"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="199"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="199"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Diverticulitis Meckel's</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="199"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Rhegmatogenous retinal detachment</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="199"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Colitis ischaemic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="199"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="199"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Large intestine polyp</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="199"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="199"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infectious mononucleosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="199"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="199"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Pyelonephritis acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="199"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="199"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Muscle strain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="199"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Radius fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="199"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="199"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="199"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Tendon rupture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="199"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rhabdomyolysis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="199"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Bile duct adenocarcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="199"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Clear cell renal cell carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="199"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Lung neoplasm malignant</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="199"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Carpal tunnel syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="199"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="199"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Ureterolithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="199"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Endometrial hyperplasia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="199"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 23</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="73" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="142" subjects_at_risk="199"/>
                <counts group_id="E3" subjects_affected="49" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" events="12" subjects_affected="11" subjects_at_risk="100"/>
                <counts group_id="E2" events="16" subjects_affected="12" subjects_at_risk="199"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="100"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="199"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="100"/>
                <counts group_id="E2" events="16" subjects_affected="12" subjects_at_risk="199"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="100"/>
                <counts group_id="E2" events="13" subjects_affected="10" subjects_at_risk="199"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="22" subjects_affected="19" subjects_at_risk="100"/>
                <counts group_id="E2" events="60" subjects_affected="52" subjects_at_risk="199"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Dental caries</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="100"/>
                <counts group_id="E2" events="12" subjects_affected="11" subjects_at_risk="199"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="59" subjects_affected="22" subjects_at_risk="100"/>
                <counts group_id="E2" events="52" subjects_affected="32" subjects_at_risk="199"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="17" subjects_affected="6" subjects_at_risk="100"/>
                <counts group_id="E2" events="14" subjects_affected="9" subjects_at_risk="199"/>
                <counts group_id="E3" events="4" subjects_affected="1" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="27" subjects_affected="18" subjects_at_risk="100"/>
                <counts group_id="E2" events="66" subjects_affected="35" subjects_at_risk="199"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="34" subjects_affected="10" subjects_at_risk="100"/>
                <counts group_id="E2" events="29" subjects_affected="17" subjects_at_risk="199"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="100"/>
                <counts group_id="E2" events="13" subjects_affected="11" subjects_at_risk="199"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="36" subjects_affected="24" subjects_at_risk="100"/>
                <counts group_id="E2" events="81" subjects_affected="53" subjects_at_risk="199"/>
                <counts group_id="E3" events="24" subjects_affected="18" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="100"/>
                <counts group_id="E2" events="13" subjects_affected="13" subjects_at_risk="199"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="100"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="199"/>
                <counts group_id="E3" events="9" subjects_affected="6" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="12" subjects_affected="8" subjects_at_risk="100"/>
                <counts group_id="E2" events="20" subjects_affected="19" subjects_at_risk="199"/>
                <counts group_id="E3" events="11" subjects_affected="9" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="100"/>
                <counts group_id="E2" events="19" subjects_affected="14" subjects_at_risk="199"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="100"/>
                <counts group_id="E2" events="12" subjects_affected="10" subjects_at_risk="199"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract inflammation</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="100"/>
                <counts group_id="E2" events="13" subjects_affected="11" subjects_at_risk="199"/>
                <counts group_id="E3" events="13" subjects_affected="9" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Transparency Anchor and Disclosure (1452)</name_or_title>
      <organization>Novo Nordisk A/S</organization>
      <phone>(+1) 866-867-7178</phone>
      <email>clinicaltrials@novonordisk.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03811574
org study id: NN9536-4382
secondary id: U1111-1201-1629
nct id: NCT03811574
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This study will look at the change in participants' body weight from the start to the end of
      the study. This is to compare the effect on body weight in people taking semaglutide (a new
      medicine) and people taking "dummy" medicine. In addition to taking the medicine,
      participants will have talks with study staff about healthy food choices, how to be more
      physically active and what participants can do to lose weight. Participants will either get
      semaglutide or "dummy" medicine - which treatment participants get is decided by chance.
      Participants are three times as likely to get semaglutide as "dummy" medicine. Participants
      will need to take 1 injection once a week. The study medicine is injected with a thin needle
      in a skinfold in the stomach, thigh or upper arm. The study will last for about one and a
      half years. Participants will have 14 clinic visits and 11 phone calls with the study doctor.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Sponsor staff involved in the clinical trial is masked according to company standard procedures
measure: Change in Body Weight (%)
time frame: Baseline (week 0), week 68
description: Change from baseline (week 0) in body weight for 'in-trial' observation period at week 68 is presented. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact (week 75).
measure: Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 5%
time frame: At week 68
description: Number of participants who achieved greater than or equal to (≥) 5% weight loss at week 68 for in-trial observation period is presented. In the reported data, 'Yes' infers the number of participants who have achieved ≥ 5% weight loss, whereas 'No' infers the number of participants who have not achieved ≥ 5% weight loss. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact (week 75).
measure: Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 10%
time frame: At week 68
description: Number of participants who achieved greater than or equal to (≥) 10% weight loss at week 68 is presented. In the reported data, 'Yes' infers the number of participants who have achieved ≥ 10% weight loss, whereas 'No' infers the number of participants who have not achieved ≥ 10% weight loss. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.
measure: Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 15%
time frame: At week 68
description: Number of participants who achieved greater than or equal to (≥) 15% weight loss at week 68 is presented. In the reported data, 'Yes' infers the number of participants who have achieved ≥ 15% weight loss, whereas 'No' infers the number of participants who have not achieved ≥ 15% weight loss. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomization to last trial-related subject-site contact.
measure: Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 20%
time frame: At week 68
description: Number of participants who achieved greater than or equal to (≥) 20% weight loss at week 68 is presented. In the reported data, 'Yes' infers the number of participants who have achieved ≥ 20% weight loss, whereas 'No' infers the number of participants who have not achieved ≥ 20% weight loss. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.
measure: Change in Waist Circumference Measured Midway Between the Lower Rib Margin and the Iliac Crest
time frame: Baseline (week 0) to week 68
description: Change in waist circumference measured midway between the lower rib margin and the iliac crest from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.
measure: Change in Waist Circumference Measured According to the JASSO (Japan Society for the Study of Obesity) Guideline
time frame: Baseline (week 0) to week 68
description: Change in Waist circumference measured according to the JASSO guideline from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.
measure: Change in Body Weight (Kg)
time frame: Baseline (week 0) to week 68
description: Change in body weight from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.
measure: Change in Body Mass Index (BMI)
time frame: Baseline (week 0) to week 68
description: Change in BMI from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.
measure: Change in Visceral Fat Area (VFA) (%)
time frame: Baseline (week 0) to week 68
description: Change in VFA from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.
measure: Change in Visceral Fat Area (VFA) Centimeter Square (cm^2)
time frame: Baseline (week 0) to week 68
description: Change in VFA from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.
measure: Change in HbA1c (%)
time frame: Baseline (week 0) to week 68
description: Change in glycosylated haemoglobin (HbA1c) from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.
measure: Change in HbA1c (mmol/Mol)
time frame: Baseline (week 0) to week 68
description: Change in glycosylated haemoglobin (HbA1c) from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.
measure: Change in Fasting Plasma Glucose
time frame: Baseline (week 0) to week 68
description: Change in fasting plasma glucose from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomization to last trial-related subject-site contact.
measure: Change in Fasting Serum Insulin-ratio to Baseline
time frame: Baseline (week 0) to week 68
description: Change in fasting serum insulin measured as milli-international units per milliliter (mIU/mL) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.
measure: Change in Systolic Blood Pressure
time frame: Baseline (week 0) to week 68
description: Change in systolic blood pressure from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.
measure: Change in Diastolic Blood Pressure
time frame: Baseline (week 0) to week 68
description: Change in diastolic blood pressure from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.
measure: Change in Total Cholesterol-ratio to Baseline
time frame: Baseline (week 0) to week 68
description: Change in total cholesterol measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.
measure: Change in High-density Lipoproteins (HDL)-Ratio to Baseline
time frame: Baseline (week 0) to week 68
description: Change in HDL measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.
measure: Change in Low-density Lipoproteins (LDL)-Ratio to Baseline
time frame: Baseline (week 0) to week 68
description: Change in LDL measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomization to last trial-related subject-site contact.
measure: Change in Very Low-density Lipoproteins (VLDL)-Ratio to Baseline
time frame: Baseline (week 0) to week 68
description: Change in VLDL measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomization to last trial-related subject-site contact.
measure: Change in Free Fatty Acids-ratio to Baseline
time frame: Baseline (week 0) to week 68
description: Change in free fatty acids measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.
measure: Change in Triglycerides-ratio to Baseline
time frame: Baseline (week 0) to week 68
description: Change in triglycerides measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.
measure: Change in High Sensitivity C-reactive Protein (hsCRP)-Ratio to Baseline
time frame: Baseline (week 0) to week 68
description: Change in hsCRP measured in milligram per ilitre (mg/L) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.
measure: Change in Plasminogen Activator Inhibitor-1 Activity-ratio to Baseline
time frame: Baseline (week 0) to week 68
description: Change in plasminogen activator inhibitor-1 (PAI-1) activity measured in arbritary units per milliliter (AU/ml) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.
measure: Change in Short Form 36 v2.0 Acute (SF-36) Score
time frame: Baseline (week 0) to week 68
description: SF-36 is a 36-item patient-reported survey of patient health that measures participant's overall health-related quality of life (HRQoL). SF-36v2™ questionnaire measured eight domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). This endpoint shows results for all the domains. The 0-100 scale scores from SF-36 were converted to norm-based scores to enable a direct interpretation in relation to distribution of scores in the 2009 U.S. general population. In metric of norm-based scores, 50 and 10 corresponds to mean and standard deviation respectively. Change from week 0 in domain scores and component summary scores were evaluated at week 68. A positive change score indicates an improvement since baseline. These endpoints were evaluated based on data from in-trial observation period which is uninterrupted time interval from randomisation to last contact with trial site.
measure: Change in Impact of Weight on Quality of Life-lite for Clinical Trials (IWQOL-Lite for CT) Score
time frame: Baseline (week 0) to week 68
description: The Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite-CT) is designed to assess the impact of changes in weight on patients' quality of life within the context of clinical trials. IWQOL-Lite-CT is a 20-item questionnaire-based instrument used to assess the impact of body weight changes on participant's overall health-related quality of life (HRQoL). All IWQOL-Lite-CT composite scores range from 0 to 100, with higher scores reflecting better levels of functioning. This endpoint shows results for 'physical function score' physical and psychosocial domains, and for total'. The endpoint was evaluated based on the data from in-trial observation period which is the uninterrupted time interval from randomisation to last contact with trial site.
measure: Number of Participants Who Achieve (Yes/no): Responder Definition Value for SF-36 Physical Functioning Score
time frame: At week 68
description: The number of participants experiencing a meaningful within participant improvement in SF-36 Physical function after 68 weeks was determined based on 3.7 threshold. The threshold of 3.7 is specific for overweight or obese population included in the study and calculated using patient global rating anchor questionnaires to reflect participants' own perspective based on Food and Drug Administration (FDA) recommendations. In the reported data, "Yes" infers the number of participants who have achieved an improvement in score greater than or equal to the threshold and "No" infers number of participants who have not achieved an improvement in score greater than or equal to the threshold. The endpoint was evaluated based on in-trial observation period which is the uninterrupted time interval from randomisation to last contact with trial site.
measure: Number of Participants Who Achieve (Yes/no): Responder Definition Value for IWQoL-Lite for CT Physical Function (5-items) Score
time frame: At week 68
description: The number of participants experiencing a meaningful within participant improvement in IWQOL-Lite-CT physical function after 68 weeks was determined based on thresholds of 14.6. The threshold of 14.6 is specific for the population with overweight or obesity included in the study and calculated using patient global rating anchor questionnaires to reflect participants' own perspective based on FDA recommendations. In the reported data, "Yes" infers the number of participants who have achieved an improvement in score greater than or equal to the threshold and "No" infers the number of participants who have not achieved an improvement in score greater than or equal to the threshold. The endpoint was evaluated based on in-trial observation period which is the uninterrupted time interval from randomisation to last contact with trial site.
measure: Number of Participants Who Achieved (Yes/no): HbA1c <7.0% (53 mmol/Mol)
time frame: At week 68
description: Number of participants who achieved HbA1c <7% (53 mmol/mol) at week 68 is presented. In the reported data, "Yes" infers the number of participants who have achieved HbA1c values less than the 7% and "No" infers the number of participants who have not achieved HbA1c values less than the 7%. The endpoint was evaluated based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.
measure: Number of Participants Who Achieved (Yes/no): HbA1c ≤6.5% (48 mmol/Mol)
time frame: At week 68
description: Number of participants who achieved HbA1c ≤6.5% (48 mmol/mol) at week 68 is presented. In the reported data, "Yes" infers the number of participants who have achieved HbA1c values less than or equal to 6.5% and "No" infers the number of participants who have not achieved HbA1c values less than or equal to 6.5%. The endpoint was evaluated based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.
measure: Number of Treatment-emergent AEs
time frame: Week 0 to week 75
description: An adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. All AEs mentioned here are treatment emergent adverse events (TEAE) defined as an event with onset during the on-treatment observation period. On-treatment observation period: the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.
measure: Number of Serious Adverse Events
time frame: Week 0 to week 75
description: A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. SAE results occurred from week 0 to week 75 is presented based on the on-treatment observation, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.
measure: Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes
time frame: Week 0 to week 75
description: Hypoglycaemic episodes with onset during on-treatment observation period were considered treatment-emergent. Number of treatment emergent severe or BG confirmed symptomatic hypoglycaemia episodes with onset during on-treatment observation period were presented. Severe hypoglycaemia: episode requiring assistance of another person to administer carbohydrate, glucagon or take other corrective actions. plasma glucose (PG) concentrations may not be available during an event, but neurological recovery following return of PG to normal is considered sufficient evidence that event was induced by low PG concentration. BG confirmed symptomatic hypoglycaemia: episode that is BG confirmed by PG value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. On-treatment observation period is interval from date of first trial product administration (week 0) to date of last trial product administration (week 68) plus 7-week follow-up period and excluding any off-treatment time intervals.
measure: Change in Pulse
time frame: Baseline (week 0) to week 68
description: Change in pulse from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals.
measure: Change in Amylase: Ratio to Baseline
time frame: Baseline (week 0) to week 68
description: Change in amylase measured in units/liter (U/L) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals.
measure: Change in Lipase: Ratio to Baseline
time frame: Baseline (week 0) to week 68
description: Change in lipase measured in units/litre (U/L) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals.
measure: Change in Calcitonin: Ratio to Baseline
time frame: Baseline (week 0) to week 68
description: Change in calcitonin measured in nanogram/litre (ng/L) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals.
measure: Change in QTCF Interval
time frame: Baseline (week 0) to week 68
description: Change in QTCF Interval from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals.
arm group label: Semaglutide 2.4 mg
arm group type: Experimental
description: Participants will receive semaglutide injections once-weekly for 68 weeks. Participants will be initiated at a once-weekly dose of 0.25 mg and follow a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), until the target dose (2.4 mg) is reached after 16 weeks. Participants will continue semaglutide 2.4 mg until week 68.
arm group label: Placebo (semaglutide 2.4 mg)
arm group type: Placebo Comparator
description: Participants will receive placebo (semaglutide) injections once-weekly for 68 weeks. Participants will be initiated at a once-weekly dose of 0.25 mg and follow a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), until the target dose (2.4 mg) is reached after 16 weeks. Participants will continue placebo (semaglutide 2.4 mg) until week 68.
arm group label: Semaglutide 1.7 mg
arm group type: Experimental
description: Participants will receive semaglutide injections once-weekly for 68 weeks. Participants will be initiated at a once-weekly dose of 0.25 mg and follow a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), until the target dose (1.7 mg) is reached after 12 weeks. Participants will continue semaglutide 1.7 mg until week 68.
arm group label: Placebo (semaglutide 1.7 mg)
arm group type: Placebo Comparator
description: Participants will receive placebo (semaglutide) injections once-weekly for 68 weeks. Participants will be initiated at a once-weekly dose of 0.25 mg and follow a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), until the target dose (1.7 mg) is reached after 12 weeks. Participants will continue placebo (semaglutide 1.7) until week 68.
intervention type: Drug
intervention name: Semaglutide
description: Semaglutide injections will be administered once-weekly by a pre-filled pen-injector at the same day of the week (to the extent possible). Injections may be administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals.
arm group label: Semaglutide 1.7 mg
arm group label: Semaglutide 2.4 mg
intervention type: Drug
intervention name: Placebo (semaglutide)
description: Placebo (semaglutide) injections will be administered once-weekly by a pre-filled pen-injector at the same day of the week (to the extent possible). Injections may be administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals.
arm group label: Placebo (semaglutide 1.7 mg)
arm group label: Placebo (semaglutide 2.4 mg)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Reporting Anchor and Disclosure (1452)
role: Study Director
affiliation: Novo Nordisk A/S
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country: Japan
country: Korea, Republic of
citation: Davies M, Faerch L, Jeppesen OK, Pakseresht A, Pedersen SD, Perreault L, Rosenstock J, Shimomura I, Viljoen A, Wadden TA, Lingvay I; STEP 2 Study Group. Semaglutide 2.4 mg once a week in adults with overweight or obesity, and type 2 diabetes (STEP 2): a randomised, double-blind, double-dummy, placebo-controlled, phase 3 trial. Lancet. 2021 Mar 13;397(10278):971-984. doi: 10.1016/S0140-6736(21)00213-0. Epub 2021 Mar 2.
PMID: 33667417
responsible party type: Sponsor
mesh term: Obesity
mesh term: Overweight
sharing ipd: Yes
ipd description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
ipd url: https://www.novonordisk-trials.com
provided document: 
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certain agreements: 
point of contact: 