xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      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/NCT05996848</url>
    </required_header>
    <id_info>
      <org_study_id>NN9838-4827</org_study_id>
      <secondary_id>U1111-1267-4364</secondary_id>
      <nct_id>NCT05996848</nct_id>
    </id_info>
    <brief_title>A Research Study to See How Well CagriSema Helps People in China With Excess Body Weight Lose Weight</brief_title>
    <acronym>REDEFINE 6</acronym>
    <official_title>Efficacy and Safety of Cagrilintide s.c. 2.4 mg in Combination With Semaglutide s.c. 2.4 mg (CagriSema s.c. 2.4 mg/2.4 mg) Once-Weekly in Chinese Participants 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>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study will look at how well the new medicine CagriSema helps people with excess body&#xD;
        weight losing weight compared to a &quot;dummy&quot; medicine and a medicine called semaglutide.&#xD;
        Participants will either get CagriSema, a dummy medicine or semaglutide. Which treatment&#xD;
        participants get is decided by chance. Participants will take one injection once a week. The&#xD;
        study medicine will be injected briefly with a thin needle, typically in the stomach, thighs&#xD;
        or upper arms. The study will last for about 1 year.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 15, 2023</start_date>
    <completion_date type="Anticipated">April 8, 2025</completion_date>
    <primary_completion_date type="Anticipated">February 18, 2025</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>Double (Participant, Investigator)</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>CagriSema 2.4 mg/2.4 mg versus placebo: Relative change in body weight</measure>
      <time_frame>From baseline (week 0) to end of treatment (week 44)</time_frame>
      <description>Measured in percentage (%)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>CagriSema 2.4 mg/2.4 mg versus placebo: Number of participants who achieve (yes/no): Body weight reduction greater than or equal to 5%</measure>
      <time_frame>From baseline (week 0) to end of treatment (week 44)</time_frame>
      <description>Measured as count of participants</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>CagriSema 2.4 mg/2.4 mg versus placebo: Number of participants who achieve (yes/no): Body weight reduction greater than or equal to 20%</measure>
      <time_frame>From baseline (week 0) to end of treatment (week 44)</time_frame>
      <description>Measured as count of participants</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg: Relative change in body weight</measure>
      <time_frame>From baseline (week 0) to end of treatment (week 44)</time_frame>
      <description>Measured in percentage (%)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CagriSema 2.4 mg/2.4 mg versus placebo: Change in waist circumference</measure>
      <time_frame>From baseline (week 0) to end of treatment (week 44)</time_frame>
      <description>Measured in centimeter (cm)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CagriSema 2.4 mg/2.4 mg versus placebo: Number of participants who achieve (yes/no): Body weight reduction greater than or equal to 10%</measure>
      <time_frame>From baseline (week 0) to end of treatment (week 44)</time_frame>
      <description>Measured as count of participants</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CagriSema 2.4 mg/2.4 mg versus placebo: Number of participants who achieve (yes/no): Body weight reduction greater than or equal to 15%</measure>
      <time_frame>From baseline (week 0) to end of treatment (week 44)</time_frame>
      <description>Measured as count of participants</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg: Change in waist circumference</measure>
      <time_frame>From baseline (week 0) to end of treatment (week 44)</time_frame>
      <description>Measured in centimeter (cm)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Change in Glycated Haemoglobin (HbA1c)</measure>
      <time_frame>From baseline (week 0) to end of treatment (week 44)</time_frame>
      <description>Measured in percentage points</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Change in Fasting Plasma Glucose (FPG)</measure>
      <time_frame>From baseline (week 0) to end of treatment (week 44)</time_frame>
      <description>Measured as millimole per liter (mmol/L)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in fasting serum insulin</measure>
      <time_frame>From baseline (week 0) to end of treatment (week 44)</time_frame>
      <description>Measured in percentage (%)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Change in Systolic Blood Pressure (SBP)</measure>
      <time_frame>From baseline (week 0) to end of treatment (week 44)</time_frame>
      <description>Measured in millimeter of mercury (mmHg)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Change in Diastolic Blood Pressure (DBP)</measure>
      <time_frame>From baseline (week 0) to end of treatment (week 44)</time_frame>
      <description>Measured in millimeter of mercury (mmHg)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in total cholesterol</measure>
      <time_frame>From baseline (week 0) to end of treatment (week 44)</time_frame>
      <description>Measured in percentage (%)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in high-density lipoprotein (HDL) cholesterol</measure>
      <time_frame>From baseline (week 0) to end of treatment (week 44)</time_frame>
      <description>Measured in percentage (%)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in low-density lipoprotein (LDL) cholesterol</measure>
      <time_frame>From baseline (week 0) to end of treatment (week 44)</time_frame>
      <description>Measured in percentage (%)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in very low-density lipoprotein (VLDL) cholesterol</measure>
      <time_frame>From baseline (week 0) to end of treatment (week 44)</time_frame>
      <description>Measured in percentage (%)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in triglycerides</measure>
      <time_frame>From baseline (week 0) to end of treatment (week 44)</time_frame>
      <description>Measured in percentage (%)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in free fatty acids</measure>
      <time_frame>From baseline (week 0) to end of treatment (week 44)</time_frame>
      <description>Measured in percentage (%)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CagriSema 2.4 mg/2.4 mg versus placebo: Change in Short Form-36 Version 2.0 (SF- 36v2) Physical Functioning score</measure>
      <time_frame>From baseline (week 0) to end of treatment (week 44)</time_frame>
      <description>Measured as score points. The SF-36v2.0 is a 36-item commonly used generic clinical outcome assessment (COA) instrument measuring health-related quality of life and general health status across disease areas. SF-36v2 questionnaire measures 8 domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). This endpoint assess the 'physical functioning domain'. The 0-100 scale scores from the SF-36 will be converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 correspond to the mean and standard deviation respectively. A positive change score indicates an improvement since baseline.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CagriSema 2.4 mg/2.4 mg versus placebo: Change in SF-36v2: Physical Component Summary Score</measure>
      <time_frame>From baseline (week 0) to end of treatment (week 44)</time_frame>
      <description>Measured as score points. The SF-36v2.0 is a 36-item commonly used generic COA instrument measuring health-related quality of life and general health status across disease areas. SF-36v2 questionnaire measures 8 domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). This endpoint assess the 'physical component summary'. The 0-100 scale scores from the SF-36 will be converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively. A positive change score indicates an improvement since baseline.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CagriSema 2.4 mg/2.4 mg versus placebo: Change in SF-36v2: Mental Component Summary score</measure>
      <time_frame>From baseline (week 0) to end of treatment (week 44)</time_frame>
      <description>Measured as score points. The SF-36v2.0 is a 36-item commonly used generic COA instrument measuring health-related quality of life and general health status across disease areas. SF-36v2 questionnaire measures 8 domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). This endpoint assess the 'mental component summary'. The 0-100 scale scores from the SF-36 will be converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively. A positive change score indicates an improvement since baseline.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CagriSema 2.4 mg/2.4 mg versus placebo: Change in Impact of Weight on Quality Of Life-Lite Clinical Trials Version (IWQOLLite- CT) Physical Function score</measure>
      <time_frame>From baseline (week 0) to end of treatment (week 44)</time_frame>
      <description>Measured as score points. IWQOL-Lite-CT version 3 is a 20-item COA instrument used to assess the impact of body weight changes in obesity studies on patient's physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score. This endpoint assess the 'physical function score'. The scores range between 0-100 where higher scores indicate a better quality of life. A positive change score indicates an improvement since baseline.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CagriSema 2.4 mg/2.4 mg versus placebo: Change in IWQOL-Lite-CT Total score</measure>
      <time_frame>From baseline (week 0) to end of treatment (week 44)</time_frame>
      <description>Measured as score points. IWQOL-Lite-CT version 3 is a 20-item COA instrument used to assess the impact of body weight changes in obesity studies on patient's physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score. This endpoint assess the 'total score'. The scores range between 0-100 where higher scores indicate a better quality of life. A positive change score indicates an improvement since baseline.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Number of Treatment Emergent Adverse Events (TEAEs)</measure>
      <time_frame>From baseline (week 0) to end of study (week 51)</time_frame>
      <description>Measured as count of events</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Number of Treatment Emergent Serious Adverse Events (TESAEs)</measure>
      <time_frame>From baseline (week 0) to end of study (week 51)</time_frame>
      <description>Measured as count of events</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of clinically significant hypoglycaemic episodes (level 2) (lesser than 3.0 mmol/L (54 milligrams per deciliter[mg/dL]), confirmed by BG meter) (only for participants with Type 2 diabetes (T2D) at screening)</measure>
      <time_frame>From baseline (week 0) to end of study (week 51)</time_frame>
      <description>Measured as count of episodes</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold (only for participants with T2D at screening)</measure>
      <time_frame>From baseline (week 0) to end of study (week 51)</time_frame>
      <description>Measured as count of episodes</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">300</enrollment>
    <condition>Obesity or Overweight</condition>
    <arm_group>
      <arm_group_label>CagriSema</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive once-weekly subcutaneous (s.c) injections of 2.4 mg cagrilintide and 2.4 mg semaglutide for 44 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Semaglutide</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants will receive once-weekly s.c injection of 2.4 mg semaglutide for 44 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Participants will receive placebo matched to cagrilintide and placebo matched to semaglutide once weekly for 44 weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Cagrilintide</intervention_name>
      <description>Participants will receive 2.4 mg cagrilintide subcutaneously.</description>
      <arm_group_label>CagriSema</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Semaglutide</intervention_name>
      <description>Participants will receive 2.4 mg semaglutide subcutaneously.</description>
      <arm_group_label>CagriSema</arm_group_label>
      <arm_group_label>Semaglutide</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo Semaglutide</intervention_name>
      <description>Participants will receive placebo matched to semaglutide subcutaneously.</description>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_label>Semaglutide</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo Cagrilintide</intervention_name>
      <description>Participants will receive placebo matched to cagrilintide subcutaneously.</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male or female&#xD;
  &#xD;
            -  Age above or equal to 18 years at the time of signing informed consent&#xD;
  &#xD;
                 1. Body Mass Index (BMI) greater than or equal to 30.0 kilograms per square meter&#xD;
                    (kg/m^2) or&#xD;
  &#xD;
                 2. BMI greater than or equal to 27.0 kg/m^2 with the presence of at least one&#xD;
                    weight-related comorbidity including, but not limited to, type 2 diabetes&#xD;
                    mellitus, hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular&#xD;
                    disease&#xD;
  &#xD;
          For participants with Type 2 diabetes (T2D) at screening the following criteria also apply:&#xD;
  &#xD;
            -  Diagnosed with type 2 diabetes mellitus greater than equal to 180 days before&#xD;
               screening&#xD;
  &#xD;
            -  Treatment with either lifestyle intervention, or treatment with 1-3 marketed oral&#xD;
               antidiabetic drugs (OADs) (metformin, α-glucosidase inhibitors (AGI), glinides,&#xD;
               sodium-glucose cotransporter 2 inhibitor (SGLT2i)), thiazolidinediones, or&#xD;
               sulphonylureas (SUs) as a single agent or in combination) according to local label&#xD;
  &#xD;
            -  Treatment with oral antidiabetic drugs should be stable (same drug(s), dose and dosing&#xD;
               frequency) for at least 60 days before screening&#xD;
  &#xD;
            -  Glycated Haemoglobin (HbA1c) 7 percent-10 percent (53-86 millimoles per mole&#xD;
               [mmol/mol]) (both inclusive) as measured by the central laboratory at screening&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          For participants without T2D at screening:&#xD;
  &#xD;
            -  HbA1c greater than or equal to 6.5 percent (48 mmol/mol) as measured by the central&#xD;
               laboratory at screening&#xD;
  &#xD;
            -  History of type 1 or type 2 diabetes mellitus&#xD;
  &#xD;
          For participants with T2D at screening:&#xD;
  &#xD;
            -  Clinically significant or severe hypoglycaemia within 6 months before screening or&#xD;
               history of hypoglycaemia unawareness&#xD;
  &#xD;
            -  Renal impairment with estimated glomerular filtration rate (eGFR) lesser than 30 milli&#xD;
               liter per min/1.73 meter square (mL/min/1.73 m^2), as measured by the central&#xD;
               laboratory at screening&#xD;
  &#xD;
            -  Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by&#xD;
               a fundus examination performed within 90 days before screening or in the period&#xD;
               between screening and randomisation. Pharmacological pupil-dilation is a requirement&#xD;
               unless using a digital fundus photography camera specified for non-dilated examination&#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 Office (dept. 2834)</last_name>
      <role>Study Director</role>
      <affiliation>Novo Nordisk A/S</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Novo Nordisk</last_name>
      <phone>(+1) 866-867-7178</phone>
      <email>clinicaltrials@novonordisk.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Novo Nordisk Investigational Site</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100853</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novo Nordisk Investigational Site</name>
        <address>
          <city>ChongQing</city>
          <state>Chongqing</state>
          <zip>404000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novo Nordisk Investigational Site</name>
        <address>
          <city>ChongQing</city>
          <state>Chongqing</state>
          <zip>404000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novo Nordisk Investigational Site</name>
        <address>
          <city>Fuzhou</city>
          <state>Fujian</state>
          <zip>350001</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novo Nordisk Investigational Site</name>
        <address>
          <city>Huizhou</city>
          <state>Guangdong</state>
          <zip>516001</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novo Nordisk Investigational Site</name>
        <address>
          <city>Hengshui</city>
          <state>Hebei</state>
          <zip>053000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novo Nordisk Investigational Site</name>
        <address>
          <city>Shijiazhuang</city>
          <state>Hebei</state>
          <zip>050000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novo Nordisk Investigational Site</name>
        <address>
          <city>Shijiazhuang</city>
          <state>Hebei</state>
          <zip>050000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novo Nordisk Investigational Site</name>
        <address>
          <city>Kaifeng</city>
          <state>Henan</state>
          <zip>450000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novo Nordisk Investigational Site</name>
        <address>
          <city>Kaifeng</city>
          <state>Henan</state>
          <zip>475000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novo Nordisk Investigational Site</name>
        <address>
          <city>Luoyang</city>
          <state>Henan</state>
          <zip>471003</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novo Nordisk Investigational Site</name>
        <address>
          <city>Luoyang</city>
          <state>Henan</state>
          <zip>471003</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novo Nordisk Investigational Site</name>
        <address>
          <city>Zhengzhou</city>
          <state>Henan</state>
          <zip>450003</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novo Nordisk Investigational Site</name>
        <address>
          <city>Zhengzhou</city>
          <state>Henan</state>
          <zip>450003</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novo Nordisk Investigational Site</name>
        <address>
          <city>Changde</city>
          <state>Hunan</state>
          <zip>415003</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novo Nordisk Investigational Site</name>
        <address>
          <city>Changzhou</city>
          <state>Jiangsu</state>
          <zip>213003</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novo Nordisk Investigational Site</name>
        <address>
          <city>Changzhou</city>
          <state>Jiangsu</state>
          <zip>213003</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novo Nordisk Investigational Site</name>
        <address>
          <city>Nanjing</city>
          <state>Jiangsu</state>
          <zip>210011</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novo Nordisk Investigational Site</name>
        <address>
          <city>Nanjing</city>
          <state>Jiangsu</state>
          <zip>210011</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novo Nordisk Investigational Site</name>
        <address>
          <city>Suzhou</city>
          <state>Jiangsu</state>
          <zip>215002</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novo Nordisk Investigational Site</name>
        <address>
          <city>Suzhou</city>
          <state>Jiangsu</state>
          <zip>215006</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novo Nordisk Investigational Site</name>
        <address>
          <city>Xuzhou</city>
          <state>Jiangsu</state>
          <zip>221002</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novo Nordisk Investigational Site</name>
        <address>
          <city>Xuzhou</city>
          <state>Jiangsu</state>
          <zip>221002</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novo Nordisk Investigational Site</name>
        <address>
          <city>Zhenjiang</city>
          <state>Jiangsu</state>
          <zip>212001</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novo Nordisk Investigational Site</name>
        <address>
          <city>Zhenjiang</city>
          <state>Jiangsu</state>
          <zip>212001</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novo Nordisk Investigational Site</name>
        <address>
          <city>Changchun</city>
          <state>Jilin</state>
          <zip>130021</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novo Nordisk Investigational Site</name>
        <address>
          <city>Changchun</city>
          <state>Jilin</state>
          <zip>130021</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novo Nordisk Investigational Site</name>
        <address>
          <city>Jin'an</city>
          <state>Shandong</state>
          <zip>250013</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novo Nordisk Investigational Site</name>
        <address>
          <city>Jin'an</city>
          <state>Shandong</state>
          <zip>250013</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novo Nordisk Investigational Site</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>200336</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novo Nordisk Investigational Site</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>200336</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novo Nordisk Investigational Site</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>201199</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novo Nordisk Investigational Site</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>201199</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novo Nordisk Investigational Site</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>201200</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novo Nordisk Investigational Site</name>
        <address>
          <city>Tianjin</city>
          <state>Tianjin</state>
          <zip>300052</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novo Nordisk Investigational Site</name>
        <address>
          <city>Tianjin</city>
          <state>Tianjin</state>
          <zip>300052</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novo Nordisk Investigational Site</name>
        <address>
          <city>Tianjin</city>
          <state>Tianjin</state>
          <zip>300211</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novo Nordisk Investigational Site</name>
        <address>
          <city>Tianjin</city>
          <state>Tianjin</state>
          <zip>300211</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novo Nordisk Investigational Site</name>
        <address>
          <city>Jingan/Shanghai</city>
          <zip>200040</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novo Nordisk Investigational Site</name>
        <address>
          <city>Jingan/Shanghai</city>
          <zip>200040</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</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>http://novonordisk-trials.com</ipd_url>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05996848
  org study id: NN9838-4827
  secondary id: U1111-1267-4364
  nct id: NCT05996848
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study will look at how well the new medicine CagriSema helps people with excess body
        weight losing weight compared to a "dummy" medicine and a medicine called semaglutide.
        Participants will either get CagriSema, a dummy medicine or semaglutide. Which treatment
        participants get is decided by chance. Participants will take one injection once a week. The
        study medicine will be injected briefly with a thin needle, typically in the stomach, thighs
        or upper arms. The study will last for about 1 year.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  masking description: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
  measure: CagriSema 2.4 mg/2.4 mg versus placebo: Relative change in body weight
  time frame: From baseline (week 0) to end of treatment (week 44)
  description: Measured in percentage (%)
  measure: CagriSema 2.4 mg/2.4 mg versus placebo: Number of participants who achieve (yes/no): Body weight reduction greater than or equal to 5%
  time frame: From baseline (week 0) to end of treatment (week 44)
  description: Measured as count of participants
  measure: CagriSema 2.4 mg/2.4 mg versus placebo: Number of participants who achieve (yes/no): Body weight reduction greater than or equal to 20%
  time frame: From baseline (week 0) to end of treatment (week 44)
  description: Measured as count of participants
  measure: CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg: Relative change in body weight
  time frame: From baseline (week 0) to end of treatment (week 44)
  description: Measured in percentage (%)
  measure: CagriSema 2.4 mg/2.4 mg versus placebo: Change in waist circumference
  time frame: From baseline (week 0) to end of treatment (week 44)
  description: Measured in centimeter (cm)
  measure: CagriSema 2.4 mg/2.4 mg versus placebo: Number of participants who achieve (yes/no): Body weight reduction greater than or equal to 10%
  time frame: From baseline (week 0) to end of treatment (week 44)
  description: Measured as count of participants
  measure: CagriSema 2.4 mg/2.4 mg versus placebo: Number of participants who achieve (yes/no): Body weight reduction greater than or equal to 15%
  time frame: From baseline (week 0) to end of treatment (week 44)
  description: Measured as count of participants
  measure: CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg: Change in waist circumference
  time frame: From baseline (week 0) to end of treatment (week 44)
  description: Measured in centimeter (cm)
  measure: CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Change in Glycated Haemoglobin (HbA1c)
  time frame: From baseline (week 0) to end of treatment (week 44)
  description: Measured in percentage points
  measure: CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Change in Fasting Plasma Glucose (FPG)
  time frame: From baseline (week 0) to end of treatment (week 44)
  description: Measured as millimole per liter (mmol/L)
  measure: CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in fasting serum insulin
  time frame: From baseline (week 0) to end of treatment (week 44)
  description: Measured in percentage (%)
  measure: CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Change in Systolic Blood Pressure (SBP)
  time frame: From baseline (week 0) to end of treatment (week 44)
  description: Measured in millimeter of mercury (mmHg)
  measure: CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Change in Diastolic Blood Pressure (DBP)
  time frame: From baseline (week 0) to end of treatment (week 44)
  description: Measured in millimeter of mercury (mmHg)
  measure: CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in total cholesterol
  time frame: From baseline (week 0) to end of treatment (week 44)
  description: Measured in percentage (%)
  measure: CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in high-density lipoprotein (HDL) cholesterol
  time frame: From baseline (week 0) to end of treatment (week 44)
  description: Measured in percentage (%)
  measure: CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in low-density lipoprotein (LDL) cholesterol
  time frame: From baseline (week 0) to end of treatment (week 44)
  description: Measured in percentage (%)
  measure: CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in very low-density lipoprotein (VLDL) cholesterol
  time frame: From baseline (week 0) to end of treatment (week 44)
  description: Measured in percentage (%)
  measure: CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in triglycerides
  time frame: From baseline (week 0) to end of treatment (week 44)
  description: Measured in percentage (%)
  measure: CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in free fatty acids
  time frame: From baseline (week 0) to end of treatment (week 44)
  description: Measured in percentage (%)
  measure: CagriSema 2.4 mg/2.4 mg versus placebo: Change in Short Form-36 Version 2.0 (SF- 36v2) Physical Functioning score
  time frame: From baseline (week 0) to end of treatment (week 44)
  description: Measured as score points. The SF-36v2.0 is a 36-item commonly used generic clinical outcome assessment (COA) instrument measuring health-related quality of life and general health status across disease areas. SF-36v2 questionnaire measures 8 domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). This endpoint assess the 'physical functioning domain'. The 0-100 scale scores from the SF-36 will be converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 correspond to the mean and standard deviation respectively. A positive change score indicates an improvement since baseline.
  measure: CagriSema 2.4 mg/2.4 mg versus placebo: Change in SF-36v2: Physical Component Summary Score
  time frame: From baseline (week 0) to end of treatment (week 44)
  description: Measured as score points. The SF-36v2.0 is a 36-item commonly used generic COA instrument measuring health-related quality of life and general health status across disease areas. SF-36v2 questionnaire measures 8 domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). This endpoint assess the 'physical component summary'. The 0-100 scale scores from the SF-36 will be converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively. A positive change score indicates an improvement since baseline.
  measure: CagriSema 2.4 mg/2.4 mg versus placebo: Change in SF-36v2: Mental Component Summary score
  time frame: From baseline (week 0) to end of treatment (week 44)
  description: Measured as score points. The SF-36v2.0 is a 36-item commonly used generic COA instrument measuring health-related quality of life and general health status across disease areas. SF-36v2 questionnaire measures 8 domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). This endpoint assess the 'mental component summary'. The 0-100 scale scores from the SF-36 will be converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively. A positive change score indicates an improvement since baseline.
  measure: CagriSema 2.4 mg/2.4 mg versus placebo: Change in Impact of Weight on Quality Of Life-Lite Clinical Trials Version (IWQOLLite- CT) Physical Function score
  time frame: From baseline (week 0) to end of treatment (week 44)
  description: Measured as score points. IWQOL-Lite-CT version 3 is a 20-item COA instrument used to assess the impact of body weight changes in obesity studies on patient's physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score. This endpoint assess the 'physical function score'. The scores range between 0-100 where higher scores indicate a better quality of life. A positive change score indicates an improvement since baseline.
  measure: CagriSema 2.4 mg/2.4 mg versus placebo: Change in IWQOL-Lite-CT Total score
  time frame: From baseline (week 0) to end of treatment (week 44)
  description: Measured as score points. IWQOL-Lite-CT version 3 is a 20-item COA instrument used to assess the impact of body weight changes in obesity studies on patient's physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score. This endpoint assess the 'total score'. The scores range between 0-100 where higher scores indicate a better quality of life. A positive change score indicates an improvement since baseline.
  measure: CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Number of Treatment Emergent Adverse Events (TEAEs)
  time frame: From baseline (week 0) to end of study (week 51)
  description: Measured as count of events
  measure: CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Number of Treatment Emergent Serious Adverse Events (TESAEs)
  time frame: From baseline (week 0) to end of study (week 51)
  description: Measured as count of events
  measure: Number of clinically significant hypoglycaemic episodes (level 2) (lesser than 3.0 mmol/L (54 milligrams per deciliter[mg/dL]), confirmed by BG meter) (only for participants with Type 2 diabetes (T2D) at screening)
  time frame: From baseline (week 0) to end of study (week 51)
  description: Measured as count of episodes
  measure: Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold (only for participants with T2D at screening)
  time frame: From baseline (week 0) to end of study (week 51)
  description: Measured as count of episodes
  arm group label: CagriSema
  arm group type: Experimental
  description: Participants will receive once-weekly subcutaneous (s.c) injections of 2.4 mg cagrilintide and 2.4 mg semaglutide for 44 weeks.
  arm group label: Semaglutide
  arm group type: Active Comparator
  description: Participants will receive once-weekly s.c injection of 2.4 mg semaglutide for 44 weeks.
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Participants will receive placebo matched to cagrilintide and placebo matched to semaglutide once weekly for 44 weeks.
  intervention type: Drug
  intervention name: Cagrilintide
  description: Participants will receive 2.4 mg cagrilintide subcutaneously.
  arm group label: CagriSema
  intervention type: Drug
  intervention name: Semaglutide
  description: Participants will receive 2.4 mg semaglutide subcutaneously.
  arm group label: CagriSema
  arm group label: Semaglutide
  intervention type: Drug
  intervention name: Placebo Semaglutide
  description: Participants will receive placebo matched to semaglutide subcutaneously.
  arm group label: Placebo
  arm group label: Semaglutide
  intervention type: Drug
  intervention name: Placebo Cagrilintide
  description: Participants will receive placebo matched to cagrilintide subcutaneously.
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Clinical Reporting Office (dept. 2834)
  role: Study Director
  affiliation: Novo Nordisk A/S
  last name: Novo Nordisk
  phone: (+1) 866-867-7178
  email: clinicaltrials@novonordisk.com
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Not yet recruiting
  country: China
  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: http://novonordisk-trials.com