<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/NCT03038620</url>
  </required_header>
  <id_info>
    <org_study_id>STU 122015-044</org_study_id>
    <nct_id>NCT03038620</nct_id>
  </id_info>
  <brief_title>Impact of Liraglutide 3.0 on Body Fat Distribution</brief_title>
  <official_title>Impact of Liraglutide 3.0 on Body Fat Distribution, Visceral Adiposity, and Cardiometabolic Risk Markers In Overweight and Obese Adults at High Risk for Cardiovascular Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas Southwestern Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Novo Nordisk A/S</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Texas Southwestern Medical Center</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a clinical study to investigate the efficacy of liraglutide compared to placebo&#xD;
      in reducing visceral adiposity measured by MRI in overweight or obese subjects at high risk&#xD;
      for cardiovascular disease after 40 weeks on-treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Obesity has long been recognized as a risk factor for all-cause mortality and morbidity,&#xD;
      including the development of cardiovascular and metabolic diseases such as coronary artery&#xD;
      disease, hypertension, insulin resistance, diabetes, and dyslipidemia. Obesity has recently&#xD;
      been formally defined as a chronic disease characterized by pathophysiological processes that&#xD;
      result in increased adipose tissue mass and can result in increased morbidity and mortality.&#xD;
      Although the health risks associated with obesity are clear, there is an emerging&#xD;
      appreciation that obesity per se, as defined by simple anthropometric measures such as waist&#xD;
      circumference or body mass index (BMI), is neither necessary nor sufficient to promote&#xD;
      cardiometabolic disease and atherosclerotic cardiovascular disease (ASCVD) risk. As a result,&#xD;
      BMI alone is an insufficient marker of risk and may not accurately identify individuals at&#xD;
      elevated risk for ASCVD. There is a pressing need to more accurately phenotype obesity to&#xD;
      identify individuals at elevated risk for ASCVD that may benefit from more intensive&#xD;
      preventive and therapeutic strategies&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">October 13, 2020</completion_date>
  <primary_completion_date type="Actual">October 13, 2020</primary_completion_date>
  <phase>Phase 4</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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Relative Percent Reduction in Visceral Adipose Tissue Mass Measured by MRI</measure>
    <time_frame>Baseline, 40 weeks</time_frame>
    <description>The effect on relative percent reduction from baseline in visceral adipose tissue mass measured by MRI after 40 weeks on treatment.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint as a percent of the baseline.&#xD;
Reduction in this variable is believed to be associated with lower cardiovascular risk.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Absolute Reduction in Visceral Adipose Tissue Volume</measure>
    <time_frame>Baseline, 40 weeks</time_frame>
    <description>The effect on absolute reduction from baseline in visceral adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint.&#xD;
Reduction in this variable is believed to be associated with lower cardiovascular risk.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative Percent Reduction in Body Weight</measure>
    <time_frame>Baseline, 40 weeks</time_frame>
    <description>The effect on relative percent reduction from baseline in body weight after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint.&#xD;
Reduction in this variable is believed to be associated with lower cardiovascular risk.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Reduction in Body Weight</measure>
    <time_frame>Baseline, 40 weeks</time_frame>
    <description>The effect on absolute reduction from baseline in body weight after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint.&#xD;
Reduction in this variable is believed to be associated with lower cardiovascular risk.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative Percent Reduction in Waist Circumference</measure>
    <time_frame>Baseline, 40 weeks</time_frame>
    <description>The effect on relative percent reduction from baseline in waist circumference after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint.&#xD;
Reduction in this variable is believed to be associated with lower cardiovascular risk.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Reduction in Waist Circumference</measure>
    <time_frame>Baseline, 40 weeks</time_frame>
    <description>The effect on absolute reduction from baseline in waist circumference after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint.&#xD;
Reduction in this variable is believed to be associated with lower cardiovascular risk.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative Percent Reduction in Total Body Adipose Tissue</measure>
    <time_frame>Baseline, 40 weeks</time_frame>
    <description>The effect on relative percent reduction from baseline in total body adipose tissue (fat) mass measured by MRI after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint.&#xD;
Reduction in this variable is believed to be associated with lower cardiovascular risk.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Reduction in Total Body Adipose Tissue</measure>
    <time_frame>Baseline, 40 weeks</time_frame>
    <description>The effect on absolute reduction from baseline in total body adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint.&#xD;
Reduction in this variable is believed to be associated with lower cardiovascular risk.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative Percent Reduction in Abdominal Subcutaneous Adipose Tissue</measure>
    <time_frame>Baseline, 40 weeks</time_frame>
    <description>The effect on relative percent reduction from baseline in abdominal subcutaneous adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Reduction in Abdominal Subcutaneous Adipose Tissue</measure>
    <time_frame>Baseline, 40 weeks</time_frame>
    <description>The effect on absolute reduction from baseline in abdominal subcutaneous adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative Percent Reduction in Lower Body Subcutaneous Adipose Tissue</measure>
    <time_frame>Baseline, 40 weeks</time_frame>
    <description>The effect on relative percent reduction from baseline in lower body subcutaneous adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Reduction in Lower Body Subcutaneous Adipose Tissue</measure>
    <time_frame>Baseline, 40 weeks</time_frame>
    <description>The effect on absolute reduction from baseline in lower body subcutaneous adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative Percent Reduction in Liver Fat Percent</measure>
    <time_frame>Baseline, 40 weeks</time_frame>
    <description>The effect on relative percent reduction from baseline in liver (hepatic) fat percentage measured by MRI after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint. Negative values reflect an increase in the value from baseline to study endpoint.&#xD;
Reduction in this variable is believed to be associated with lower cardiovascular risk.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Reduction in Liver Fat Percent</measure>
    <time_frame>Baseline, 40 weeks</time_frame>
    <description>The effect on absolute reduction from baseline in liver (hepatic) fat percentage measured by MRI after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint. Negative values reflect an increase in the value from baseline to study endpoint.&#xD;
Reduction in this variable is believed to be associated with lower cardiovascular risk.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative Percent Reduction in Total Body Lean Volume</measure>
    <time_frame>Baseline, 40 weeks</time_frame>
    <description>The effect on relative percent reduction from baseline in total body lean volume (fat-free mass) measured by MRI after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Reduction in Total Body Lean Volume</measure>
    <time_frame>Baseline, 40 weeks</time_frame>
    <description>The effect on absolute reduction from baseline in total body lean volume (fat-free mass) measured by MRI after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative Percent Reduction in Total Thigh Muscle Volume</measure>
    <time_frame>Baseline, 40 weeks</time_frame>
    <description>The effect on relative percent reduction from baseline in total thigh muscle volume measured by MRI after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Reduction in Total Thigh Muscle Volume</measure>
    <time_frame>Baseline, 40 weeks</time_frame>
    <description>The effect on absolute reduction from baseline in total thigh muscle volume measured by MRI after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative Percent Reduction in Mean Anterior Thigh Muscle Fat Infiltration Percent</measure>
    <time_frame>Baseline,40 weeks</time_frame>
    <description>The effect on relative percent reduction from baseline in mean anterior thigh muscle fat infiltration percent measured by MRI after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint. Negative values reflect an increase in the value from baseline to study endpoint.&#xD;
Reduction in this variable is believed to be associated with lower risk for metabolic disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Reduction in Mean Anterior Thigh Muscle Fat Infiltration Percent</measure>
    <time_frame>Baseline,40 weeks</time_frame>
    <description>The effect on absolute reduction from baseline in mean anterior thigh muscle fat infiltration percent measured by MRI after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint. Negative values reflect an increase in the value from baseline to study endpoint.&#xD;
Reduction in this variable is believed to be associated with lower risk for metabolic disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in VAT/SAT Ratio</measure>
    <time_frame>Baseline, 40 weeks</time_frame>
    <description>The effect on absolute reduction from baseline in Visceral adipose tissue/subcutaneous adipose tissue (VAT/SAT) ratio measured by MRI after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint.&#xD;
This is the ratio of visceral adipose tissue to subcutaneous adipose tissue and it is thought that lower values (relatively less visceral adipose tissue) are better.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Total Fat/Fat-free Mass Ratio</measure>
    <time_frame>Baseline, 40 weeks</time_frame>
    <description>The effect on absolute change from baseline in total fat/fat-free mass ratio measured by MRI after 40 weeks on treatment versus placebo.&#xD;
This is a ratio of fat to lean mass and it is believed that lower values (less fat relative to lean mass) is better.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative Percent Change in Fasting Blood Glucose</measure>
    <time_frame>Baseline, 40 weeks</time_frame>
    <description>The relative percent change in fasting blood glucose from baseline to study end point as a percent of baseline by treatment group.&#xD;
Negative values reflect a reduction. This is a blood based biomarker for diabetes in which normal levels are desirable (70-100 mg/dL).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative Percent Change in Insulin</measure>
    <time_frame>Baseline, 40 weeks</time_frame>
    <description>The relative percent change in insulin from baseline to study end point as a percent of baseline by treatment group.&#xD;
Positive values reflect an increase. Collection was impacted by coronavirus disease 2019 (COVID-19) and limitations to in person study visits, limiting complete collection of data for this measure.&#xD;
This is a blood based biomarker in which lower fasting levels are desirable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative Percent Change in HOMA-IR</measure>
    <time_frame>Baseline, 40 weeks</time_frame>
    <description>The relative percent change in HOMA-IR from baseline to study end point as a percent of baseline by treatment group.&#xD;
Positive values reflect an increase. Collection was impacted by coronavirus disease 2019 (COVID-19) and limitations to in person study visits, limiting complete collection of data for this measure.&#xD;
The relative percent change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) from baseline to study end point by treatment group measures insulin resistance. Levels above 1.9 signal early insulin resistance, while levels above 2.9 signal significant insulin resistance. There will be optimal insulin sensitivity if HOMA-IR is less than 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative Percent Change in C-reactive Protein</measure>
    <time_frame>Baseline, 40 weeks</time_frame>
    <description>The relative percent change in biomarker of inflammation: C-reactive protein (CRP) from baseline to study end point as a percent of baseline by treatment group.&#xD;
Negative values reflect a decrease. Collection was impacted by coronavirus disease 2019 (COVID-19) and limitations to in person study visits, limiting complete collection of data for this measure.&#xD;
This is a blood based test for which lower values are associated with less inflammation and lower risk for cardiovascular events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative Percent Change in Triglyceride/HDL-C Ratio</measure>
    <time_frame>Baseline, 40 weeks</time_frame>
    <description>The relative percent change in triglyceride/HDL-C ratio from baseline to study end point as a percent of baseline by treatment group.&#xD;
Negative values reflect a decrease. Collection was impacted by coronavirus disease 2019 (COVID-19) and limitations to in person study visits, limiting complete collection of data for this measure.&#xD;
Lower ratio of triglycerides to HDL-cholesterol is associated with less insulin resistance and lower cardiovascular risk.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative Percent Change in Nt-proBNP</measure>
    <time_frame>Baseline, 40 weeks</time_frame>
    <description>The relative percent change in N-terminal Pro Brain Natriuretic Peptides (Nt-proBNP) from baseline to study end point as a percent of baseline by treatment group.&#xD;
Negative values reflect a decrease. Collection was impacted by coronavirus disease 2019 (COVID-19) and limitations to in person study visits, limiting complete collection of data for this measure.&#xD;
NT-proBNP is a blood based biomarker. Lower levels are associated with lower risk for heart failure and cardiovascular events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Change in Fasting Blood Glucose</measure>
    <time_frame>Baseline,40 weeks</time_frame>
    <description>The change in fasting blood glucose from baseline to study end point by treatment group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Change in Insulin</measure>
    <time_frame>Baseline, 40 weeks</time_frame>
    <description>The absolute change in insulin from baseline to study end point by treatment group. Collection was impacted by COVID-19 and changes to study visits.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Change in HOMA-IR</measure>
    <time_frame>Baseline, 40 weeks</time_frame>
    <description>The absolute change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) from baseline to study end point by treatment group measures insulin resistance. Levels above 1.9 signal early insulin resistance, while levels above 2.9 signal significant insulin resistance. There will be optimal insulin sensitivity if HOMA-IR is less than 1. Collection was impacted by COVID-19 and changes to study visits.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Change in CRP</measure>
    <time_frame>Baseline, 40 weeks</time_frame>
    <description>The change in Markers of inflammation: C-reactive protein (CRP) from baseline to study end point by treatment group. Collection was impacted by COVID-19 and changes to study visits.&#xD;
This is a blood based test for which lower values are associated with less inflammation and lower risk for cardiovascular events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Change in Triglyceride/HDL-C Ratio</measure>
    <time_frame>Baseline, 40 weeks</time_frame>
    <description>The change in triglyceride/HDL-C ratio from baseline to study end point by treatment group. Collection was impacted by COVID-19 and changes to study visits.&#xD;
Lower ratio of triglycerides to HDL-cholesterol is associated with less insulin resistance and lower cardiovascular risk.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Change in Nt-proBNP</measure>
    <time_frame>Baseline, 40 weeks</time_frame>
    <description>The change in N-terminal Pro Brain Natriuretic Peptides (Nt-proBNP) from baseline to study end point by treatment group. Collection was impacted by COVID-19 and changes to study visits.&#xD;
NT-proBNP is a blood based biomarker. Lower levels are associated with lower risk for heart failure and cardiovascular events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Heart Rate</measure>
    <time_frame>Baseline, 40 weeks</time_frame>
    <description>The change in heart rate/pulse from baseline to study endpoint visit by treatment group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Blood Pressure</measure>
    <time_frame>Baseline, 40 weeks</time_frame>
    <description>The change in systolic blood pressure from baseline to study endpoint visit by treatment group.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>On-treatment Time, Weeks</measure>
    <time_frame>weeks</time_frame>
    <description>The mean duration of treatment during study follow-up.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">235</enrollment>
  <condition>Obesity, Visceral</condition>
  <condition>Cardiovascular Diseases</condition>
  <condition>Fat Disorder</condition>
  <arm_group>
    <arm_group_label>Liraglutide 3.0 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug: Liraglutide Active Drug&#xD;
Other Names:&#xD;
Saxenda&#xD;
Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL&#xD;
Other Names:&#xD;
Placebo&#xD;
Saline injection&#xD;
Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Liraglutide</intervention_name>
    <description>Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
    <arm_group_label>Liraglutide 3.0 mg</arm_group_label>
    <other_name>Saxenda</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Saline injection</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 35 years&#xD;
&#xD;
          -  Able to provide informed consent&#xD;
&#xD;
          -  BMI ≥ 30 kg/m2 or ≥ 27 kg/m2 with metabolic syndrome&#xD;
&#xD;
          -  Metabolic syndrome is defined as at least three of the following:3&#xD;
&#xD;
               1. waist circumference &gt; 102 cm (40 in) in men and 88 cm (35 in) in women&#xD;
&#xD;
               2. triglycerides &gt; 150 mg/dL or on treatment for hypertriglyceridemia&#xD;
&#xD;
               3. HDL cholesterol &lt; 40 mg/dL in men and &lt; 50 mg/dL in women&#xD;
&#xD;
               4. blood pressure &gt; 130/85 mmHg or on treatment for hypertension&#xD;
&#xD;
               5. fasting glucose &gt; 100 mg/dL&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Treatment with Glucagon-like peptide-1 (GLP-1) receptor agonists (including&#xD;
             liraglutide, exenatide or others as they become available), dipeptidyl peptidase 4&#xD;
             (DPP-4) inhibitors or insulin within the last 3 months.&#xD;
&#xD;
          -  Receipt of any anti-obesity drug or supplement within 1 month prior to screening for&#xD;
             this trial.&#xD;
&#xD;
          -  Self-reported or clinically documented history of significant fluctuations (&gt;5%&#xD;
             change) in weight within 3 months prior to screening for this trial.&#xD;
&#xD;
          -  History of diabetes mellitus (type 1 or 2) or on treatment with anti-diabetes&#xD;
             medication.&#xD;
&#xD;
          -  History of chronic pancreatitis or idiopathic acute pancreatitis (current or prior&#xD;
             history).&#xD;
&#xD;
          -  History of gallbladder disease (cholelithiasis or cholecystitis).&#xD;
&#xD;
          -  Chronic kidney disease stage III or greater (eGFR&lt;60 mL/min).&#xD;
&#xD;
          -  Obesity induced by other endocrinologic disorders (e.g. Cushing Syndrome).&#xD;
&#xD;
          -  Current or history of treatment with medications that may cause significant weight&#xD;
             gain, within 1 month prior to screening for this trial, including systemic&#xD;
             corticosteroids (except for a short course of treatment, i.e., 7- 10 days), tri-cyclic&#xD;
             antidepressants, atypical antipsychotic and mood stabilizers (e.g., imipramine,&#xD;
             amitryptiline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine,&#xD;
             clozapine, olanzapine, valproic acid and its derivatives, and lithium).&#xD;
&#xD;
          -  Diet attempts using herbal supplements or over-the-counter medications within 1 month&#xD;
             prior to screening for this trial.&#xD;
&#xD;
          -  Current participation in an organized weight reduction program or within the last 1&#xD;
             month prior to screening for this trial.&#xD;
&#xD;
          -  Participation in a clinical trial within the last 3 months prior to screening for this&#xD;
             trial.&#xD;
&#xD;
          -  Familial or personal history of multiple endocrine neoplasia type 2 or familial&#xD;
             medullary thyroid carcinoma.&#xD;
&#xD;
          -  Personal history of non-familial medullary thyroid carcinoma.&#xD;
&#xD;
          -  History of Major Depressive Disorder within the last 2 years.&#xD;
&#xD;
          -  History of other severe psychiatric disorders, e.g., schizophrenia, bipolar disorder.&#xD;
&#xD;
          -  Any lifetime history of a suicide attempt.&#xD;
&#xD;
          -  A history of any suicidal behavior in the last month prior to randomization.&#xD;
&#xD;
          -  Surgery scheduled for the trial duration period, except for minor surgical procedures,&#xD;
             at the discretion of the Investigator.&#xD;
&#xD;
          -  Known or suspected hypersensitivity to trial product(s) or related product(s).&#xD;
&#xD;
          -  Known or suspected abuse of alcohol or narcotics.&#xD;
&#xD;
          -  Language barrier, mental incapacity, unwillingness or inability to understand.&#xD;
&#xD;
          -  Females of childbearing potential who are pregnant, breast-feeding or intend to become&#xD;
             pregnant or are not using adequate contraceptive methods. These include abstinence and&#xD;
             the following methods: diaphragm with spermicide, condom with spermicide (by male&#xD;
             partner), intrauterine device, sponge, spermicide, Norplant®, Depo-Provera® or oral&#xD;
             contraceptives.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Parag Joshi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Texas Southwestern Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Texas Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Astrup A, Rossner S, Van Gaal L, Rissanen A, Niskanen L, Al Hakim M, Madsen J, Rasmussen MF, Lean ME; NN8022-1807 Study Group. Effects of liraglutide in the treatment of obesity: a randomised, double-blind, placebo-controlled study. Lancet. 2009 Nov 7;374(9701):1606-16. doi: 10.1016/S0140-6736(09)61375-1. Epub 2009 Oct 23. Erratum In: Lancet. 2010 Mar 20;375(9719):984.</citation>
    <PMID>19853906</PMID>
  </reference>
  <reference>
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  <verification_date>October 2021</verification_date>
  <study_first_submitted>January 30, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <results_first_submitted>September 13, 2021</results_first_submitted>
  <results_first_submitted_qc>October 20, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">November 19, 2021</results_first_posted>
  <last_update_submitted>October 20, 2021</last_update_submitted>
  <last_update_submitted_qc>October 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Texas Southwestern Medical Center</investigator_affiliation>
    <investigator_full_name>Parag Joshi</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <keyword>Obesity</keyword>
  <keyword>Visceral</keyword>
  <keyword>Cardiovascular Disease</keyword>
  <keyword>Fat</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Obesity, Abdominal</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liraglutide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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 24, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/20/NCT03038620/Prot_001.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>July 28, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/20/NCT03038620/SAP_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Liraglutide 3.0 mg</title>
          <description>Drug: Liraglutide Active Drug&#xD;
Other Names:&#xD;
Saxenda&#xD;
Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL&#xD;
Other Names:&#xD;
Placebo&#xD;
Saline injection&#xD;
Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="92"/>
                <participants group_id="P2" count="93"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="73"/>
                <participants group_id="P2" count="55"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="38"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="23"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Uninterpretable Outcome (Imaging)</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Participants analyzed if they completed an endpoint assessment and had interpretable imaging data.</population>
      <group_list>
        <group group_id="B1">
          <title>Liraglutide 3.0 mg</title>
          <description>Drug: Liraglutide Active Drug&#xD;
Other Names:&#xD;
Saxenda&#xD;
Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL&#xD;
Other Names:&#xD;
Placebo&#xD;
Saline injection&#xD;
Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
        </group>
        <group group_id="B3">
          <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="73"/>
            <count group_id="B2" value="55"/>
            <count group_id="B3" value="128"/>
          </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="49.6" spread="9.8"/>
                    <measurement group_id="B2" value="50.9" spread="8.8"/>
                    <measurement group_id="B3" value="50.2" spread="9.4"/>
                  </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="67"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="118"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="10"/>
                  </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="18"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                    <measurement group_id="B2" value="43"/>
                    <measurement group_id="B3" value="98"/>
                  </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_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_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="47"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="78"/>
                  </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_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Total Adipose tissue</title>
          <units>Liters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39.6" spread="8.9"/>
                    <measurement group_id="B2" value="40.9" spread="9.8"/>
                    <measurement group_id="B3" value="40.2" spread="9.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Visceral Adipose Tissue</title>
          <units>Liters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.5" spread="2.1"/>
                    <measurement group_id="B2" value="4.5" spread="1.7"/>
                    <measurement group_id="B3" value="4.5" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Abdominal Adipose Tissue</title>
          <units>Liters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15.6" spread="4.3"/>
                    <measurement group_id="B2" value="16.2" spread="4.2"/>
                    <measurement group_id="B3" value="15.8" spread="4.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Lower Body Adipose Tissue</title>
          <description>MRI based quantification of adipose tissue from the lower body.</description>
          <units>Liters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14.7" spread="4.3"/>
                    <measurement group_id="B2" value="15.6" spread="5.0"/>
                    <measurement group_id="B3" value="15.1" spread="4.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Liver Fat</title>
          <units>percentage of fat</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.6" spread="7.9"/>
                    <measurement group_id="B2" value="6.1" spread="6.1"/>
                    <measurement group_id="B3" value="6.9" spread="7.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Total Body Lean Tissue</title>
          <units>Liters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21.6" spread="3.8"/>
                    <measurement group_id="B2" value="21.5" spread="3.5"/>
                    <measurement group_id="B3" value="21.5" spread="3.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Fasting Blood Glucose</title>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="100.6" spread="12.9"/>
                    <measurement group_id="B2" value="99.1" spread="14.4"/>
                    <measurement group_id="B3" value="100" spread="13.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Fasting Insulin</title>
          <units>mIU/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16.3" spread="10.8"/>
                    <measurement group_id="B2" value="18.0" spread="17.0"/>
                    <measurement group_id="B3" value="17.0" spread="13.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Triglycerides (mg/dL)</title>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="109.4" spread="49.7"/>
                    <measurement group_id="B2" value="118.3" spread="50.6"/>
                    <measurement group_id="B3" value="113.2" spread="50.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>C-reactive Protein (mg/L)</title>
          <units>mg/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.0" spread="4.3"/>
                    <measurement group_id="B2" value="7.8" spread="6.8"/>
                    <measurement group_id="B3" value="7.9" spread="5.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>N-terminal prohormone of brain natriuretic peptide (NT-proBNP) (pg/mL)</title>
          <units>pg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59.6" spread="44.1"/>
                    <measurement group_id="B2" value="63.2" spread="44.7"/>
                    <measurement group_id="B3" value="61.1" spread="44.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Participants with Hypertension</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Participants with Hyperlipidemia</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Participants with Prediabetes</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Systolic blood pressure (mmHg)</title>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="130.3" spread="14.9"/>
                    <measurement group_id="B2" value="125.8" spread="13.9"/>
                    <measurement group_id="B3" value="128.4" spread="14.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diastolic blood pressure (mmHg)</title>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="80.9" spread="7.8"/>
                    <measurement group_id="B2" value="78.5" spread="8.3"/>
                    <measurement group_id="B3" value="79.8" spread="8.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight (kg)</title>
          <units>Kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="101.0" spread="17.9"/>
                    <measurement group_id="B2" value="102.3" spread="17.9"/>
                    <measurement group_id="B3" value="101.5" spread="17.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height (m)</title>
          <units>m</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.6" spread="0.1"/>
                    <measurement group_id="B2" value="1.6" spread="0.1"/>
                    <measurement group_id="B3" value="1.6" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI (kg/m^2)</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37.2" spread="6.0"/>
                    <measurement group_id="B2" value="38.1" spread="6.1"/>
                    <measurement group_id="B3" value="37.6" spread="6.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Waist Circumference (cm)</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="105.5" spread="12.2"/>
                    <measurement group_id="B2" value="104.8" spread="10.6"/>
                    <measurement group_id="B3" value="105.2" spread="11.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline kcal/day</title>
          <units>kcal/day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2177" spread="195"/>
                    <measurement group_id="B2" value="2196" spread="189"/>
                    <measurement group_id="B3" value="2185" spread="192"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Relative Percent Reduction in Visceral Adipose Tissue Mass Measured by MRI</title>
        <description>The effect on relative percent reduction from baseline in visceral adipose tissue mass measured by MRI after 40 weeks on treatment.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint as a percent of the baseline.&#xD;
Reduction in this variable is believed to be associated with lower cardiovascular risk.</description>
        <time_frame>Baseline, 40 weeks</time_frame>
        <population>Those who completed study endpoint assessment (interpretable MRI at baseline and at study end).</population>
        <group_list>
          <group group_id="O1">
            <title>Liraglutide 3.0 mg</title>
            <description>Drug: Liraglutide Active Drug&#xD;
Other Names:&#xD;
Saxenda&#xD;
Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL&#xD;
Other Names:&#xD;
Placebo&#xD;
Saline injection&#xD;
Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
        </group_list>
        <measure>
          <title>Relative Percent Reduction in Visceral Adipose Tissue Mass Measured by MRI</title>
          <description>The effect on relative percent reduction from baseline in visceral adipose tissue mass measured by MRI after 40 weeks on treatment.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint as a percent of the baseline.&#xD;
Reduction in this variable is believed to be associated with lower cardiovascular risk.</description>
          <population>Those who completed study endpoint assessment (interpretable MRI at baseline and at study end).</population>
          <units>percentage of reduction in VAT</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.49" lower_limit="10.4" upper_limit="14.6"/>
                    <measurement group_id="O2" value="1.63" lower_limit="-1.62" upper_limit="4.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Reduction in Visceral Adipose Tissue Volume</title>
        <description>The effect on absolute reduction from baseline in visceral adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint.&#xD;
Reduction in this variable is believed to be associated with lower cardiovascular risk.</description>
        <time_frame>Baseline, 40 weeks</time_frame>
        <population>Those who completed baseline and endpoint MRI with interpretable images.</population>
        <group_list>
          <group group_id="O1">
            <title>Liraglutide 3.0 mg</title>
            <description>Drug: Liraglutide Active Drug&#xD;
Other Names:&#xD;
Saxenda&#xD;
Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL&#xD;
Other Names:&#xD;
Placebo&#xD;
Saline injection&#xD;
Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Reduction in Visceral Adipose Tissue Volume</title>
          <description>The effect on absolute reduction from baseline in visceral adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint.&#xD;
Reduction in this variable is believed to be associated with lower cardiovascular risk.</description>
          <population>Those who completed baseline and endpoint MRI with interpretable images.</population>
          <units>Liters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.53" spread="0.43"/>
                    <measurement group_id="O2" value="0.10" spread="0.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Relative Percent Reduction in Body Weight</title>
        <description>The effect on relative percent reduction from baseline in body weight after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint.&#xD;
Reduction in this variable is believed to be associated with lower cardiovascular risk.</description>
        <time_frame>Baseline, 40 weeks</time_frame>
        <population>Those who completed baseline and endpoint MRI with interpretable images.</population>
        <group_list>
          <group group_id="O1">
            <title>Liraglutide 3.0 mg</title>
            <description>Drug: Liraglutide Active Drug&#xD;
Other Names:&#xD;
Saxenda&#xD;
Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL&#xD;
Other Names:&#xD;
Placebo&#xD;
Saline injection&#xD;
Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
        </group_list>
        <measure>
          <title>Relative Percent Reduction in Body Weight</title>
          <description>The effect on relative percent reduction from baseline in body weight after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint.&#xD;
Reduction in this variable is believed to be associated with lower cardiovascular risk.</description>
          <population>Those who completed baseline and endpoint MRI with interpretable images.</population>
          <units>percent 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="73"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.59" spread="4.80"/>
                    <measurement group_id="O2" value="1.19" spread="4.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Reduction in Body Weight</title>
        <description>The effect on absolute reduction from baseline in body weight after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint.&#xD;
Reduction in this variable is believed to be associated with lower cardiovascular risk.</description>
        <time_frame>Baseline, 40 weeks</time_frame>
        <population>Those who completed baseline and endpoint MRI with interpretable images.</population>
        <group_list>
          <group group_id="O1">
            <title>Liraglutide 3.0 mg</title>
            <description>Drug: Liraglutide Active Drug&#xD;
Other Names:&#xD;
Saxenda&#xD;
Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL&#xD;
Other Names:&#xD;
Placebo&#xD;
Saline injection&#xD;
Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Reduction in Body Weight</title>
          <description>The effect on absolute reduction from baseline in body weight after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint.&#xD;
Reduction in this variable is believed to be associated with lower cardiovascular risk.</description>
          <population>Those who completed baseline and endpoint MRI with interpretable images.</population>
          <units>Kilograms</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.75" spread="5.35"/>
                    <measurement group_id="O2" value="1.3" spread="4.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Relative Percent Reduction in Waist Circumference</title>
        <description>The effect on relative percent reduction from baseline in waist circumference after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint.&#xD;
Reduction in this variable is believed to be associated with lower cardiovascular risk.</description>
        <time_frame>Baseline, 40 weeks</time_frame>
        <population>Those who completed baseline and endpoint MRI with interpretable images.</population>
        <group_list>
          <group group_id="O1">
            <title>Liraglutide 3.0 mg</title>
            <description>Drug: Liraglutide Active Drug&#xD;
Other Names:&#xD;
Saxenda&#xD;
Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL&#xD;
Other Names:&#xD;
Placebo&#xD;
Saline injection&#xD;
Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
        </group_list>
        <measure>
          <title>Relative Percent Reduction in Waist Circumference</title>
          <description>The effect on relative percent reduction from baseline in waist circumference after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint.&#xD;
Reduction in this variable is believed to be associated with lower cardiovascular risk.</description>
          <population>Those who completed baseline and endpoint MRI with interpretable images.</population>
          <units>percent 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="73"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.90" spread="6.43"/>
                    <measurement group_id="O2" value="4.16" spread="6.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Reduction in Waist Circumference</title>
        <description>The effect on absolute reduction from baseline in waist circumference after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint.&#xD;
Reduction in this variable is believed to be associated with lower cardiovascular risk.</description>
        <time_frame>Baseline, 40 weeks</time_frame>
        <population>Those who completed baseline and endpoint MRI with interpretable images.</population>
        <group_list>
          <group group_id="O1">
            <title>Liraglutide 3.0 mg</title>
            <description>Drug: Liraglutide Active Drug&#xD;
Other Names:&#xD;
Saxenda&#xD;
Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL&#xD;
Other Names:&#xD;
Placebo&#xD;
Saline injection&#xD;
Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Reduction in Waist Circumference</title>
          <description>The effect on absolute reduction from baseline in waist circumference after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint.&#xD;
Reduction in this variable is believed to be associated with lower cardiovascular risk.</description>
          <population>Those who completed baseline and endpoint MRI with interpretable images.</population>
          <units>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="73"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.4" spread="6.8"/>
                    <measurement group_id="O2" value="4.6" spread="6.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Relative Percent Reduction in Total Body Adipose Tissue</title>
        <description>The effect on relative percent reduction from baseline in total body adipose tissue (fat) mass measured by MRI after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint.&#xD;
Reduction in this variable is believed to be associated with lower cardiovascular risk.</description>
        <time_frame>Baseline, 40 weeks</time_frame>
        <population>Those who completed baseline and endpoint MRI with interpretable images.</population>
        <group_list>
          <group group_id="O1">
            <title>Liraglutide 3.0 mg</title>
            <description>Drug: Liraglutide Active Drug&#xD;
Other Names:&#xD;
Saxenda&#xD;
Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL&#xD;
Other Names:&#xD;
Placebo&#xD;
Saline injection&#xD;
Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
        </group_list>
        <measure>
          <title>Relative Percent Reduction in Total Body Adipose Tissue</title>
          <description>The effect on relative percent reduction from baseline in total body adipose tissue (fat) mass measured by MRI after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint.&#xD;
Reduction in this variable is believed to be associated with lower cardiovascular risk.</description>
          <population>Those who completed baseline and endpoint MRI with interpretable images.</population>
          <units>percent 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="73"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.59" spread="7.15"/>
                    <measurement group_id="O2" value="0.95" spread="7.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Reduction in Total Body Adipose Tissue</title>
        <description>The effect on absolute reduction from baseline in total body adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint.&#xD;
Reduction in this variable is believed to be associated with lower cardiovascular risk.</description>
        <time_frame>Baseline, 40 weeks</time_frame>
        <population>Those who completed baseline and endpoint MRI with interpretable images.</population>
        <group_list>
          <group group_id="O1">
            <title>Liraglutide 3.0 mg</title>
            <description>Drug: Liraglutide Active Drug&#xD;
Other Names:&#xD;
Saxenda&#xD;
Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL&#xD;
Other Names:&#xD;
Placebo&#xD;
Saline injection&#xD;
Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Reduction in Total Body Adipose Tissue</title>
          <description>The effect on absolute reduction from baseline in total body adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint.&#xD;
Reduction in this variable is believed to be associated with lower cardiovascular risk.</description>
          <population>Those who completed baseline and endpoint MRI with interpretable images.</population>
          <units>Liters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.76" spread="2.87"/>
                    <measurement group_id="O2" value="0.42" spread="2.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Relative Percent Reduction in Abdominal Subcutaneous Adipose Tissue</title>
        <description>The effect on relative percent reduction from baseline in abdominal subcutaneous adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint.</description>
        <time_frame>Baseline, 40 weeks</time_frame>
        <population>Those who completed baseline and endpoint MRI with interpretable images.</population>
        <group_list>
          <group group_id="O1">
            <title>Liraglutide 3.0 mg</title>
            <description>Drug: Liraglutide Active Drug&#xD;
Other Names:&#xD;
Saxenda&#xD;
Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL&#xD;
Other Names:&#xD;
Placebo&#xD;
Saline injection&#xD;
Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
        </group_list>
        <measure>
          <title>Relative Percent Reduction in Abdominal Subcutaneous Adipose Tissue</title>
          <description>The effect on relative percent reduction from baseline in abdominal subcutaneous adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint.</description>
          <population>Those who completed baseline and endpoint MRI with interpretable images.</population>
          <units>percent 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="73"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.87" spread="8.23"/>
                    <measurement group_id="O2" value="0.77" spread="8.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Reduction in Abdominal Subcutaneous Adipose Tissue</title>
        <description>The effect on absolute reduction from baseline in abdominal subcutaneous adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint.</description>
        <time_frame>Baseline, 40 weeks</time_frame>
        <population>Those who completed baseline and endpoint MRI with interpretable images.</population>
        <group_list>
          <group group_id="O1">
            <title>Liraglutide 3.0 mg</title>
            <description>Drug: Liraglutide Active Drug&#xD;
Other Names:&#xD;
Saxenda&#xD;
Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL&#xD;
Other Names:&#xD;
Placebo&#xD;
Saline injection&#xD;
Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Reduction in Abdominal Subcutaneous Adipose Tissue</title>
          <description>The effect on absolute reduction from baseline in abdominal subcutaneous adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint.</description>
          <population>Those who completed baseline and endpoint MRI with interpretable images.</population>
          <units>Liters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.52" spread="1.31"/>
                    <measurement group_id="O2" value="0.15" spread="1.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Relative Percent Reduction in Lower Body Subcutaneous Adipose Tissue</title>
        <description>The effect on relative percent reduction from baseline in lower body subcutaneous adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint.</description>
        <time_frame>Baseline, 40 weeks</time_frame>
        <population>Those who completed baseline and endpoint MRI with interpretable images.</population>
        <group_list>
          <group group_id="O1">
            <title>Liraglutide 3.0 mg</title>
            <description>Drug: Liraglutide Active Drug&#xD;
Other Names:&#xD;
Saxenda&#xD;
Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL&#xD;
Other Names:&#xD;
Placebo&#xD;
Saline injection&#xD;
Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
        </group_list>
        <measure>
          <title>Relative Percent Reduction in Lower Body Subcutaneous Adipose Tissue</title>
          <description>The effect on relative percent reduction from baseline in lower body subcutaneous adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint.</description>
          <population>Those who completed baseline and endpoint MRI with interpretable images.</population>
          <units>percent 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="73"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.95" spread="7.61"/>
                    <measurement group_id="O2" value="1.29" spread="8.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Reduction in Lower Body Subcutaneous Adipose Tissue</title>
        <description>The effect on absolute reduction from baseline in lower body subcutaneous adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint.</description>
        <time_frame>Baseline, 40 weeks</time_frame>
        <population>Those who completed baseline and endpoint MRI with interpretable images.</population>
        <group_list>
          <group group_id="O1">
            <title>Liraglutide 3.0 mg</title>
            <description>Drug: Liraglutide Active Drug&#xD;
Other Names:&#xD;
Saxenda&#xD;
Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL&#xD;
Other Names:&#xD;
Placebo&#xD;
Saline injection&#xD;
Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Reduction in Lower Body Subcutaneous Adipose Tissue</title>
          <description>The effect on absolute reduction from baseline in lower body subcutaneous adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint.</description>
          <population>Those who completed baseline and endpoint MRI with interpretable images.</population>
          <units>Liters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.51" spread="1.34"/>
                    <measurement group_id="O2" value="0.19" spread="1.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Relative Percent Reduction in Liver Fat Percent</title>
        <description>The effect on relative percent reduction from baseline in liver (hepatic) fat percentage measured by MRI after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint. Negative values reflect an increase in the value from baseline to study endpoint.&#xD;
Reduction in this variable is believed to be associated with lower cardiovascular risk.</description>
        <time_frame>Baseline, 40 weeks</time_frame>
        <population>Those who completed baseline and endpoint MRI with interpretable images.</population>
        <group_list>
          <group group_id="O1">
            <title>Liraglutide 3.0 mg</title>
            <description>Drug: Liraglutide Active Drug&#xD;
Other Names:&#xD;
Saxenda&#xD;
Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL&#xD;
Other Names:&#xD;
Placebo&#xD;
Saline injection&#xD;
Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
        </group_list>
        <measure>
          <title>Relative Percent Reduction in Liver Fat Percent</title>
          <description>The effect on relative percent reduction from baseline in liver (hepatic) fat percentage measured by MRI after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint. Negative values reflect an increase in the value from baseline to study endpoint.&#xD;
Reduction in this variable is believed to be associated with lower cardiovascular risk.</description>
          <population>Those who completed baseline and endpoint MRI with interpretable images.</population>
          <units>percent 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="73"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.37" spread="61.43"/>
                    <measurement group_id="O2" value="-20.63" spread="104.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Reduction in Liver Fat Percent</title>
        <description>The effect on absolute reduction from baseline in liver (hepatic) fat percentage measured by MRI after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint. Negative values reflect an increase in the value from baseline to study endpoint.&#xD;
Reduction in this variable is believed to be associated with lower cardiovascular risk.</description>
        <time_frame>Baseline, 40 weeks</time_frame>
        <population>Those who completed baseline and endpoint MRI with interpretable images are reported here.</population>
        <group_list>
          <group group_id="O1">
            <title>Liraglutide 3.0 mg</title>
            <description>Drug: Liraglutide Active Drug&#xD;
Other Names:&#xD;
Saxenda&#xD;
Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL&#xD;
Other Names:&#xD;
Placebo&#xD;
Saline injection&#xD;
Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Reduction in Liver Fat Percent</title>
          <description>The effect on absolute reduction from baseline in liver (hepatic) fat percentage measured by MRI after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint. Negative values reflect an increase in the value from baseline to study endpoint.&#xD;
Reduction in this variable is believed to be associated with lower cardiovascular risk.</description>
          <population>Those who completed baseline and endpoint MRI with interpretable images are reported here.</population>
          <units>percentage of liver fat</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.35" spread="5.35"/>
                    <measurement group_id="O2" value="-0.01" spread="3.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Relative Percent Reduction in Total Body Lean Volume</title>
        <description>The effect on relative percent reduction from baseline in total body lean volume (fat-free mass) measured by MRI after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint.</description>
        <time_frame>Baseline, 40 weeks</time_frame>
        <population>Those who completed baseline and endpoint MRI with interpretable images are reported here.</population>
        <group_list>
          <group group_id="O1">
            <title>Liraglutide 3.0 mg</title>
            <description>Drug: Liraglutide Active Drug&#xD;
Other Names:&#xD;
Saxenda&#xD;
Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL&#xD;
Other Names:&#xD;
Placebo&#xD;
Saline injection&#xD;
Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
        </group_list>
        <measure>
          <title>Relative Percent Reduction in Total Body Lean Volume</title>
          <description>The effect on relative percent reduction from baseline in total body lean volume (fat-free mass) measured by MRI after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint.</description>
          <population>Those who completed baseline and endpoint MRI with interpretable images are reported here.</population>
          <units>percent 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="73"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.47" spread="4.04"/>
                    <measurement group_id="O2" value="0.90" spread="3.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Reduction in Total Body Lean Volume</title>
        <description>The effect on absolute reduction from baseline in total body lean volume (fat-free mass) measured by MRI after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint.</description>
        <time_frame>Baseline, 40 weeks</time_frame>
        <population>Those who completed baseline and endpoint MRI with interpretable images are reported here.</population>
        <group_list>
          <group group_id="O1">
            <title>Liraglutide 3.0 mg</title>
            <description>Drug: Liraglutide Active Drug&#xD;
Other Names:&#xD;
Saxenda&#xD;
Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL&#xD;
Other Names:&#xD;
Placebo&#xD;
Saline injection&#xD;
Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Reduction in Total Body Lean Volume</title>
          <description>The effect on absolute reduction from baseline in total body lean volume (fat-free mass) measured by MRI after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint.</description>
          <population>Those who completed baseline and endpoint MRI with interpretable images are reported here.</population>
          <units>Liters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.54" spread="0.88"/>
                    <measurement group_id="O2" value="0.17" spread="0.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Relative Percent Reduction in Total Thigh Muscle Volume</title>
        <description>The effect on relative percent reduction from baseline in total thigh muscle volume measured by MRI after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint.</description>
        <time_frame>Baseline, 40 weeks</time_frame>
        <population>Those who completed baseline and endpoint MRI with interpretable images are reported here.</population>
        <group_list>
          <group group_id="O1">
            <title>Liraglutide 3.0 mg</title>
            <description>Drug: Liraglutide Active Drug&#xD;
Other Names:&#xD;
Saxenda&#xD;
Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL&#xD;
Other Names:&#xD;
Placebo&#xD;
Saline injection&#xD;
Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
        </group_list>
        <measure>
          <title>Relative Percent Reduction in Total Thigh Muscle Volume</title>
          <description>The effect on relative percent reduction from baseline in total thigh muscle volume measured by MRI after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint.</description>
          <population>Those who completed baseline and endpoint MRI with interpretable images are reported here.</population>
          <units>percent 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="73"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.48" spread="3.55"/>
                    <measurement group_id="O2" value="0.68" spread="3.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Reduction in Total Thigh Muscle Volume</title>
        <description>The effect on absolute reduction from baseline in total thigh muscle volume measured by MRI after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint.</description>
        <time_frame>Baseline, 40 weeks</time_frame>
        <population>Those who completed baseline and endpoint MRI with interpretable images are reported here.</population>
        <group_list>
          <group group_id="O1">
            <title>Liraglutide 3.0 mg</title>
            <description>Drug: Liraglutide Active Drug&#xD;
Other Names:&#xD;
Saxenda&#xD;
Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL&#xD;
Other Names:&#xD;
Placebo&#xD;
Saline injection&#xD;
Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Reduction in Total Thigh Muscle Volume</title>
          <description>The effect on absolute reduction from baseline in total thigh muscle volume measured by MRI after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint.</description>
          <population>Those who completed baseline and endpoint MRI with interpretable images are reported here.</population>
          <units>Liters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.35" spread="0.35"/>
                    <measurement group_id="O2" value="0.06" spread="0.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Relative Percent Reduction in Mean Anterior Thigh Muscle Fat Infiltration Percent</title>
        <description>The effect on relative percent reduction from baseline in mean anterior thigh muscle fat infiltration percent measured by MRI after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint. Negative values reflect an increase in the value from baseline to study endpoint.&#xD;
Reduction in this variable is believed to be associated with lower risk for metabolic disease.</description>
        <time_frame>Baseline,40 weeks</time_frame>
        <population>Those who completed baseline and endpoint MRI with interpretable images are reported here.</population>
        <group_list>
          <group group_id="O1">
            <title>Liraglutide 3.0 mg</title>
            <description>Drug: Liraglutide Active Drug&#xD;
Other Names:&#xD;
Saxenda&#xD;
Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL&#xD;
Other Names:&#xD;
Placebo&#xD;
Saline injection&#xD;
Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
        </group_list>
        <measure>
          <title>Relative Percent Reduction in Mean Anterior Thigh Muscle Fat Infiltration Percent</title>
          <description>The effect on relative percent reduction from baseline in mean anterior thigh muscle fat infiltration percent measured by MRI after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint. Negative values reflect an increase in the value from baseline to study endpoint.&#xD;
Reduction in this variable is believed to be associated with lower risk for metabolic disease.</description>
          <population>Those who completed baseline and endpoint MRI with interpretable images are reported here.</population>
          <units>percent 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="73"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.81" spread="6.51"/>
                    <measurement group_id="O2" value="-0.29" spread="6.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Reduction in Mean Anterior Thigh Muscle Fat Infiltration Percent</title>
        <description>The effect on absolute reduction from baseline in mean anterior thigh muscle fat infiltration percent measured by MRI after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint. Negative values reflect an increase in the value from baseline to study endpoint.&#xD;
Reduction in this variable is believed to be associated with lower risk for metabolic disease</description>
        <time_frame>Baseline,40 weeks</time_frame>
        <population>Those who completed baseline and endpoint MRI with interpretable images are reported here.</population>
        <group_list>
          <group group_id="O1">
            <title>Liraglutide 3.0 mg</title>
            <description>Drug: Liraglutide Active Drug&#xD;
Other Names:&#xD;
Saxenda&#xD;
Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL&#xD;
Other Names:&#xD;
Placebo&#xD;
Saline injection&#xD;
Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Reduction in Mean Anterior Thigh Muscle Fat Infiltration Percent</title>
          <description>The effect on absolute reduction from baseline in mean anterior thigh muscle fat infiltration percent measured by MRI after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint. Negative values reflect an increase in the value from baseline to study endpoint.&#xD;
Reduction in this variable is believed to be associated with lower risk for metabolic disease</description>
          <population>Those who completed baseline and endpoint MRI with interpretable images are reported here.</population>
          <units>percentage of fat infiltration</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.23" spread="0.49"/>
                    <measurement group_id="O2" value="0.01" spread="0.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in VAT/SAT Ratio</title>
        <description>The effect on absolute reduction from baseline in Visceral adipose tissue/subcutaneous adipose tissue (VAT/SAT) ratio measured by MRI after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint.&#xD;
This is the ratio of visceral adipose tissue to subcutaneous adipose tissue and it is thought that lower values (relatively less visceral adipose tissue) are better.</description>
        <time_frame>Baseline, 40 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Liraglutide 3.0 mg</title>
            <description>Drug: Liraglutide Active Drug&#xD;
Other Names:&#xD;
Saxenda&#xD;
Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL&#xD;
Other Names:&#xD;
Placebo&#xD;
Saline injection&#xD;
Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in VAT/SAT Ratio</title>
          <description>The effect on absolute reduction from baseline in Visceral adipose tissue/subcutaneous adipose tissue (VAT/SAT) ratio measured by MRI after 40 weeks on treatment versus placebo.&#xD;
Positive numbers reflect the reduction in the value from baseline to study endpoint.&#xD;
This is the ratio of visceral adipose tissue to subcutaneous adipose tissue and it is thought that lower values (relatively less visceral adipose tissue) are better.</description>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01" spread="0.03"/>
                    <measurement group_id="O2" value="0" spread="0.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Total Fat/Fat-free Mass Ratio</title>
        <description>The effect on absolute change from baseline in total fat/fat-free mass ratio measured by MRI after 40 weeks on treatment versus placebo.&#xD;
This is a ratio of fat to lean mass and it is believed that lower values (less fat relative to lean mass) is better.</description>
        <time_frame>Baseline, 40 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Liraglutide 3.0 mg</title>
            <description>Drug: Liraglutide Active Drug&#xD;
Other Names:&#xD;
Saxenda&#xD;
Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL&#xD;
Other Names:&#xD;
Placebo&#xD;
Saline injection&#xD;
Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Total Fat/Fat-free Mass Ratio</title>
          <description>The effect on absolute change from baseline in total fat/fat-free mass ratio measured by MRI after 40 weeks on treatment versus placebo.&#xD;
This is a ratio of fat to lean mass and it is believed that lower values (less fat relative to lean mass) is better.</description>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.23" spread="7.25"/>
                    <measurement group_id="O2" value="0.01" spread="7.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Relative Percent Change in Fasting Blood Glucose</title>
        <description>The relative percent change in fasting blood glucose from baseline to study end point as a percent of baseline by treatment group.&#xD;
Negative values reflect a reduction. This is a blood based biomarker for diabetes in which normal levels are desirable (70-100 mg/dL).</description>
        <time_frame>Baseline, 40 weeks</time_frame>
        <population>Complete case analysis was done. Those who completed baseline and endpoint study visits and had results, were only analyzed and reported here.</population>
        <group_list>
          <group group_id="O1">
            <title>Liraglutide 3.0 mg</title>
            <description>Drug: Liraglutide Active Drug&#xD;
Other Names:&#xD;
Saxenda&#xD;
Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL&#xD;
Other Names:&#xD;
Placebo&#xD;
Saline injection&#xD;
Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
        </group_list>
        <measure>
          <title>Relative Percent Change in Fasting Blood Glucose</title>
          <description>The relative percent change in fasting blood glucose from baseline to study end point as a percent of baseline by treatment group.&#xD;
Negative values reflect a reduction. This is a blood based biomarker for diabetes in which normal levels are desirable (70-100 mg/dL).</description>
          <population>Complete case analysis was done. Those who completed baseline and endpoint study visits and had results, were only analyzed and reported here.</population>
          <units>percent 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="73"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.62" spread="10.77"/>
                    <measurement group_id="O2" value="0.83" spread="13.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Relative Percent Change in Insulin</title>
        <description>The relative percent change in insulin from baseline to study end point as a percent of baseline by treatment group.&#xD;
Positive values reflect an increase. Collection was impacted by coronavirus disease 2019 (COVID-19) and limitations to in person study visits, limiting complete collection of data for this measure.&#xD;
This is a blood based biomarker in which lower fasting levels are desirable.</description>
        <time_frame>Baseline, 40 weeks</time_frame>
        <population>Complete case analysis was done. Those who completed baseline and endpoint study visits and had results, were only analyzed and reported here.</population>
        <group_list>
          <group group_id="O1">
            <title>Liraglutide 3.0 mg</title>
            <description>Drug: Liraglutide Active Drug&#xD;
Other Names:&#xD;
Saxenda&#xD;
Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL&#xD;
Other Names:&#xD;
Placebo&#xD;
Saline injection&#xD;
Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
        </group_list>
        <measure>
          <title>Relative Percent Change in Insulin</title>
          <description>The relative percent change in insulin from baseline to study end point as a percent of baseline by treatment group.&#xD;
Positive values reflect an increase. Collection was impacted by coronavirus disease 2019 (COVID-19) and limitations to in person study visits, limiting complete collection of data for this measure.&#xD;
This is a blood based biomarker in which lower fasting levels are desirable.</description>
          <population>Complete case analysis was done. Those who completed baseline and endpoint study visits and had results, were only analyzed and reported here.</population>
          <units>percent 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="72"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.58" spread="70.69"/>
                    <measurement group_id="O2" value="7.73" spread="58.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Relative Percent Change in HOMA-IR</title>
        <description>The relative percent change in HOMA-IR from baseline to study end point as a percent of baseline by treatment group.&#xD;
Positive values reflect an increase. Collection was impacted by coronavirus disease 2019 (COVID-19) and limitations to in person study visits, limiting complete collection of data for this measure.&#xD;
The relative percent change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) from baseline to study end point by treatment group measures insulin resistance. Levels above 1.9 signal early insulin resistance, while levels above 2.9 signal significant insulin resistance. There will be optimal insulin sensitivity if HOMA-IR is less than 1.</description>
        <time_frame>Baseline, 40 weeks</time_frame>
        <population>Complete case analysis was done. Those who completed baseline and endpoint study visits and had results, were only analyzed and reported here.</population>
        <group_list>
          <group group_id="O1">
            <title>Liraglutide 3.0 mg</title>
            <description>Drug: Liraglutide Active Drug&#xD;
Other Names:&#xD;
Saxenda&#xD;
Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL&#xD;
Other Names:&#xD;
Placebo&#xD;
Saline injection&#xD;
Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
        </group_list>
        <measure>
          <title>Relative Percent Change in HOMA-IR</title>
          <description>The relative percent change in HOMA-IR from baseline to study end point as a percent of baseline by treatment group.&#xD;
Positive values reflect an increase. Collection was impacted by coronavirus disease 2019 (COVID-19) and limitations to in person study visits, limiting complete collection of data for this measure.&#xD;
The relative percent change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) from baseline to study end point by treatment group measures insulin resistance. Levels above 1.9 signal early insulin resistance, while levels above 2.9 signal significant insulin resistance. There will be optimal insulin sensitivity if HOMA-IR is less than 1.</description>
          <population>Complete case analysis was done. Those who completed baseline and endpoint study visits and had results, were only analyzed and reported here.</population>
          <units>percent 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="72"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.35" spread="71.44"/>
                    <measurement group_id="O2" value="11.85" spread="69.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Relative Percent Change in C-reactive Protein</title>
        <description>The relative percent change in biomarker of inflammation: C-reactive protein (CRP) from baseline to study end point as a percent of baseline by treatment group.&#xD;
Negative values reflect a decrease. Collection was impacted by coronavirus disease 2019 (COVID-19) and limitations to in person study visits, limiting complete collection of data for this measure.&#xD;
This is a blood based test for which lower values are associated with less inflammation and lower risk for cardiovascular events.</description>
        <time_frame>Baseline, 40 weeks</time_frame>
        <population>Complete case analysis was done. Those who completed baseline and endpoint study visits and had results, were only analyzed and reported here.</population>
        <group_list>
          <group group_id="O1">
            <title>Liraglutide 3.0 mg</title>
            <description>Drug: Liraglutide Active Drug&#xD;
Other Names:&#xD;
Saxenda&#xD;
Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL&#xD;
Other Names:&#xD;
Placebo&#xD;
Saline injection&#xD;
Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
        </group_list>
        <measure>
          <title>Relative Percent Change in C-reactive Protein</title>
          <description>The relative percent change in biomarker of inflammation: C-reactive protein (CRP) from baseline to study end point as a percent of baseline by treatment group.&#xD;
Negative values reflect a decrease. Collection was impacted by coronavirus disease 2019 (COVID-19) and limitations to in person study visits, limiting complete collection of data for this measure.&#xD;
This is a blood based test for which lower values are associated with less inflammation and lower risk for cardiovascular events.</description>
          <population>Complete case analysis was done. Those who completed baseline and endpoint study visits and had results, were only analyzed and reported here.</population>
          <units>percent 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="27"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-19.91" spread="32.75"/>
                    <measurement group_id="O2" value="19.02" spread="76.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Relative Percent Change in Triglyceride/HDL-C Ratio</title>
        <description>The relative percent change in triglyceride/HDL-C ratio from baseline to study end point as a percent of baseline by treatment group.&#xD;
Negative values reflect a decrease. Collection was impacted by coronavirus disease 2019 (COVID-19) and limitations to in person study visits, limiting complete collection of data for this measure.&#xD;
Lower ratio of triglycerides to HDL-cholesterol is associated with less insulin resistance and lower cardiovascular risk.</description>
        <time_frame>Baseline, 40 weeks</time_frame>
        <population>Complete case analysis was done. Those who completed baseline and endpoint study visits and had results, were only analyzed and reported here.</population>
        <group_list>
          <group group_id="O1">
            <title>Liraglutide 3.0 mg</title>
            <description>Drug: Liraglutide Active Drug&#xD;
Other Names:&#xD;
Saxenda&#xD;
Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL&#xD;
Other Names:&#xD;
Placebo&#xD;
Saline injection&#xD;
Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
        </group_list>
        <measure>
          <title>Relative Percent Change in Triglyceride/HDL-C Ratio</title>
          <description>The relative percent change in triglyceride/HDL-C ratio from baseline to study end point as a percent of baseline by treatment group.&#xD;
Negative values reflect a decrease. Collection was impacted by coronavirus disease 2019 (COVID-19) and limitations to in person study visits, limiting complete collection of data for this measure.&#xD;
Lower ratio of triglycerides to HDL-cholesterol is associated with less insulin resistance and lower cardiovascular risk.</description>
          <population>Complete case analysis was done. Those who completed baseline and endpoint study visits and had results, were only analyzed and reported here.</population>
          <units>percent 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="42"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.10" spread="30.23"/>
                    <measurement group_id="O2" value="-2.18" spread="28.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Relative Percent Change in Nt-proBNP</title>
        <description>The relative percent change in N-terminal Pro Brain Natriuretic Peptides (Nt-proBNP) from baseline to study end point as a percent of baseline by treatment group.&#xD;
Negative values reflect a decrease. Collection was impacted by coronavirus disease 2019 (COVID-19) and limitations to in person study visits, limiting complete collection of data for this measure.&#xD;
NT-proBNP is a blood based biomarker. Lower levels are associated with lower risk for heart failure and cardiovascular events.</description>
        <time_frame>Baseline, 40 weeks</time_frame>
        <population>Complete case analysis was done. Those who completed baseline and endpoint study visits and had results, were only analyzed and reported here.</population>
        <group_list>
          <group group_id="O1">
            <title>Liraglutide 3.0 mg</title>
            <description>Drug: Liraglutide Active Drug&#xD;
Other Names:&#xD;
Saxenda&#xD;
Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL&#xD;
Other Names:&#xD;
Placebo&#xD;
Saline injection&#xD;
Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
        </group_list>
        <measure>
          <title>Relative Percent Change in Nt-proBNP</title>
          <description>The relative percent change in N-terminal Pro Brain Natriuretic Peptides (Nt-proBNP) from baseline to study end point as a percent of baseline by treatment group.&#xD;
Negative values reflect a decrease. Collection was impacted by coronavirus disease 2019 (COVID-19) and limitations to in person study visits, limiting complete collection of data for this measure.&#xD;
NT-proBNP is a blood based biomarker. Lower levels are associated with lower risk for heart failure and cardiovascular events.</description>
          <population>Complete case analysis was done. Those who completed baseline and endpoint study visits and had results, were only analyzed and reported here.</population>
          <units>percent 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="58"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.10" spread="78.5"/>
                    <measurement group_id="O2" value="20.47" spread="79.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Change in Fasting Blood Glucose</title>
        <description>The change in fasting blood glucose from baseline to study end point by treatment group.</description>
        <time_frame>Baseline,40 weeks</time_frame>
        <population>Complete case analysis was done. Those who completed baseline and endpoint study visits and had results, were only analyzed and reported here.</population>
        <group_list>
          <group group_id="O1">
            <title>Liraglutide 3.0 mg</title>
            <description>Drug: Liraglutide Active Drug&#xD;
Other Names:&#xD;
Saxenda&#xD;
Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL&#xD;
Other Names:&#xD;
Placebo&#xD;
Saline injection&#xD;
Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change in Fasting Blood Glucose</title>
          <description>The change in fasting blood glucose from baseline to study end point by treatment group.</description>
          <population>Complete case analysis was done. Those who completed baseline and endpoint study visits and had results, were only analyzed and reported here.</population>
          <units>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="73"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.49" spread="12.41"/>
                    <measurement group_id="O2" value="-0.22" spread="12.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Change in Insulin</title>
        <description>The absolute change in insulin from baseline to study end point by treatment group. Collection was impacted by COVID-19 and changes to study visits.</description>
        <time_frame>Baseline, 40 weeks</time_frame>
        <population>Complete case analysis was done. Those who completed baseline and endpoint study visits and had results, were only analyzed and reported here.</population>
        <group_list>
          <group group_id="O1">
            <title>Liraglutide 3.0 mg</title>
            <description>Drug: Liraglutide Active Drug&#xD;
Other Names:&#xD;
Saxenda&#xD;
Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL&#xD;
Other Names:&#xD;
Placebo&#xD;
Saline injection&#xD;
Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change in Insulin</title>
          <description>The absolute change in insulin from baseline to study end point by treatment group. Collection was impacted by COVID-19 and changes to study visits.</description>
          <population>Complete case analysis was done. Those who completed baseline and endpoint study visits and had results, were only analyzed and reported here.</population>
          <units>mIU/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="72"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.75" spread="9.67"/>
                    <measurement group_id="O2" value="-1.48" spread="12.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Change in HOMA-IR</title>
        <description>The absolute change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) from baseline to study end point by treatment group measures insulin resistance. Levels above 1.9 signal early insulin resistance, while levels above 2.9 signal significant insulin resistance. There will be optimal insulin sensitivity if HOMA-IR is less than 1. Collection was impacted by COVID-19 and changes to study visits.</description>
        <time_frame>Baseline, 40 weeks</time_frame>
        <population>Complete case analysis was done. Those who completed baseline and endpoint study visits and had results, were only analyzed and reported here.</population>
        <group_list>
          <group group_id="O1">
            <title>Liraglutide 3.0 mg</title>
            <description>Drug: Liraglutide Active Drug&#xD;
Other Names:&#xD;
Saxenda&#xD;
Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL&#xD;
Other Names:&#xD;
Placebo&#xD;
Saline injection&#xD;
Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change in HOMA-IR</title>
          <description>The absolute change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) from baseline to study end point by treatment group measures insulin resistance. Levels above 1.9 signal early insulin resistance, while levels above 2.9 signal significant insulin resistance. There will be optimal insulin sensitivity if HOMA-IR is less than 1. Collection was impacted by COVID-19 and changes to study visits.</description>
          <population>Complete case analysis was done. Those who completed baseline and endpoint study visits and had results, were only analyzed and reported here.</population>
          <units>Molar units</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="72"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.15" spread="3.15"/>
                    <measurement group_id="O2" value="-0.69" spread="5.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Change in CRP</title>
        <description>The change in Markers of inflammation: C-reactive protein (CRP) from baseline to study end point by treatment group. Collection was impacted by COVID-19 and changes to study visits.&#xD;
This is a blood based test for which lower values are associated with less inflammation and lower risk for cardiovascular events.</description>
        <time_frame>Baseline, 40 weeks</time_frame>
        <population>Complete case analysis was done. Those who completed baseline and endpoint study visits and had results, were only analyzed and reported here.</population>
        <group_list>
          <group group_id="O1">
            <title>Liraglutide 3.0 mg</title>
            <description>Drug: Liraglutide Active Drug&#xD;
Other Names:&#xD;
Saxenda&#xD;
Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL&#xD;
Other Names:&#xD;
Placebo&#xD;
Saline injection&#xD;
Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change in CRP</title>
          <description>The change in Markers of inflammation: C-reactive protein (CRP) from baseline to study end point by treatment group. Collection was impacted by COVID-19 and changes to study visits.&#xD;
This is a blood based test for which lower values are associated with less inflammation and lower risk for cardiovascular events.</description>
          <population>Complete case analysis was done. Those who completed baseline and endpoint study visits and had results, were only analyzed and reported here.</population>
          <units>mg/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.18" spread="3.37"/>
                    <measurement group_id="O2" value="-0.64" spread="6.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Change in Triglyceride/HDL-C Ratio</title>
        <description>The change in triglyceride/HDL-C ratio from baseline to study end point by treatment group. Collection was impacted by COVID-19 and changes to study visits.&#xD;
Lower ratio of triglycerides to HDL-cholesterol is associated with less insulin resistance and lower cardiovascular risk.</description>
        <time_frame>Baseline, 40 weeks</time_frame>
        <population>Complete case analysis was done. Those who completed baseline and endpoint study visits and had results, were only analyzed and reported here.</population>
        <group_list>
          <group group_id="O1">
            <title>Liraglutide 3.0 mg</title>
            <description>Drug: Liraglutide Active Drug&#xD;
Other Names:&#xD;
Saxenda&#xD;
Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL&#xD;
Other Names:&#xD;
Placebo&#xD;
Saline injection&#xD;
Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change in Triglyceride/HDL-C Ratio</title>
          <description>The change in triglyceride/HDL-C ratio from baseline to study end point by treatment group. Collection was impacted by COVID-19 and changes to study visits.&#xD;
Lower ratio of triglycerides to HDL-cholesterol is associated with less insulin resistance and lower cardiovascular risk.</description>
          <population>Complete case analysis was done. Those who completed baseline and endpoint study visits and had results, were only analyzed and reported here.</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.02" spread="0.83"/>
                    <measurement group_id="O2" value="-0.16" spread="0.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Change in Nt-proBNP</title>
        <description>The change in N-terminal Pro Brain Natriuretic Peptides (Nt-proBNP) from baseline to study end point by treatment group. Collection was impacted by COVID-19 and changes to study visits.&#xD;
NT-proBNP is a blood based biomarker. Lower levels are associated with lower risk for heart failure and cardiovascular events.</description>
        <time_frame>Baseline, 40 weeks</time_frame>
        <population>Complete case analysis was done. Those who completed baseline and endpoint study visits and had results, were only analyzed and reported here.</population>
        <group_list>
          <group group_id="O1">
            <title>Liraglutide 3.0 mg</title>
            <description>Drug: Liraglutide Active Drug&#xD;
Other Names:&#xD;
Saxenda&#xD;
Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL&#xD;
Other Names:&#xD;
Placebo&#xD;
Saline injection&#xD;
Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change in Nt-proBNP</title>
          <description>The change in N-terminal Pro Brain Natriuretic Peptides (Nt-proBNP) from baseline to study end point by treatment group. Collection was impacted by COVID-19 and changes to study visits.&#xD;
NT-proBNP is a blood based biomarker. Lower levels are associated with lower risk for heart failure and cardiovascular events.</description>
          <population>Complete case analysis was done. Those who completed baseline and endpoint study visits and had results, were only analyzed and reported here.</population>
          <units>pg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.10" spread="48.82"/>
                    <measurement group_id="O2" value="1.44" spread="41.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Heart Rate</title>
        <description>The change in heart rate/pulse from baseline to study endpoint visit by treatment group.</description>
        <time_frame>Baseline, 40 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Liraglutide 3.0 mg</title>
            <description>Drug: Liraglutide Active Drug&#xD;
Other Names:&#xD;
Saxenda&#xD;
Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL&#xD;
Other Names:&#xD;
Placebo&#xD;
Saline injection&#xD;
Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Heart Rate</title>
          <description>The change in heart rate/pulse from baseline to study endpoint visit by treatment group.</description>
          <units>beats per 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="73"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.84" spread="12.95"/>
                    <measurement group_id="O2" value="2.67" spread="11.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Blood Pressure</title>
        <description>The change in systolic blood pressure from baseline to study endpoint visit by treatment group.</description>
        <time_frame>Baseline, 40 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Liraglutide 3.0 mg</title>
            <description>Drug: Liraglutide Active Drug&#xD;
Other Names:&#xD;
Saxenda&#xD;
Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL&#xD;
Other Names:&#xD;
Placebo&#xD;
Saline injection&#xD;
Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Blood Pressure</title>
          <description>The change in systolic blood pressure from baseline to study endpoint visit by treatment group.</description>
          <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="73"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.84" spread="17.98"/>
                    <measurement group_id="O2" value="-0.02" spread="16.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>On-treatment Time, Weeks</title>
        <description>The mean duration of treatment during study follow-up.</description>
        <time_frame>weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Liraglutide 3.0 mg</title>
            <description>Drug: Liraglutide Active Drug&#xD;
Other Names:&#xD;
Saxenda&#xD;
Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL&#xD;
Other Names:&#xD;
Placebo&#xD;
Saline injection&#xD;
Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
          </group>
        </group_list>
        <measure>
          <title>On-treatment Time, Weeks</title>
          <description>The mean duration of treatment during study follow-up.</description>
          <units>weeks</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.2" spread="8.6"/>
                    <measurement group_id="O2" value="36.1" spread="8.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>For the entire duration of the study: 40 weeks.</time_frame>
      <desc>Adverse events collected at each study visit. GI side effects captured and reported in summary form.</desc>
      <group_list>
        <group group_id="E1">
          <title>Liraglutide 3.0 mg</title>
          <description>Drug: Liraglutide Active Drug&#xD;
Other Names:&#xD;
Saxenda&#xD;
Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL&#xD;
Other Names:&#xD;
Placebo&#xD;
Saline injection&#xD;
Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.&#xD;
Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.</description>
        </group>
      </group_list>
      <serious_events>
        <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="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <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="53" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="34" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>GI related</sub_title>
                <description>Constipation, nausea/vomiting, upset stomach, diarrhea</description>
                <counts group_id="E1" events="43" subjects_affected="43" subjects_at_risk="92"/>
                <counts group_id="E2" events="12" subjects_affected="12" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>fever</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="92"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Respiratory Tract infection</sub_title>
                <description>Upper Respiratory Infection (URI) or pharyngitis</description>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="92"/>
                <counts group_id="E2" events="14" subjects_affected="14" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>joint pain</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="92"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>headache</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="92"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>insomnia</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="92"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>dizziness</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="92"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Injection site reaction</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="92"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="93"/>
              </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>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Results reported according to updated statistical analysis plan published 7/28/2020 on CT.gov website. The updated 7/28/2020 analysis plan accounted for changes in data collection (blood biomarkers) during COVID-19 pandemic and was submitted and published prior to study completion and prior to study un-blinding with updated terminology for study endpoints compared to original protocol.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Parag Joshi</name_or_title>
      <organization>UT Southwestern Medical Center</organization>
      <phone>2146458000</phone>
      <email>parag.joshi@utsouthwestern.edu</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/NCT03038620
org study id: STU 122015-044
nct id: NCT03038620
lead sponsor: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
This study is a clinical study to investigate the efficacy of liraglutide compared to placebo
      in reducing visceral adiposity measured by MRI in overweight or obese subjects at high risk
      for cardiovascular disease after 40 weeks on-treatment.
Obesity has long been recognized as a risk factor for all-cause mortality and morbidity,
      including the development of cardiovascular and metabolic diseases such as coronary artery
      disease, hypertension, insulin resistance, diabetes, and dyslipidemia. Obesity has recently
      been formally defined as a chronic disease characterized by pathophysiological processes that
      result in increased adipose tissue mass and can result in increased morbidity and mortality.
      Although the health risks associated with obesity are clear, there is an emerging
      appreciation that obesity per se, as defined by simple anthropometric measures such as waist
      circumference or body mass index (BMI), is neither necessary nor sufficient to promote
      cardiometabolic disease and atherosclerotic cardiovascular disease (ASCVD) risk. As a result,
      BMI alone is an insufficient marker of risk and may not accurately identify individuals at
      elevated risk for ASCVD. There is a pressing need to more accurately phenotype obesity to
      identify individuals at elevated risk for ASCVD that may benefit from more intensive
      preventive and therapeutic strategies
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Relative Percent Reduction in Visceral Adipose Tissue Mass Measured by MRI
time frame: Baseline, 40 weeks
description: The effect on relative percent reduction from baseline in visceral adipose tissue mass measured by MRI after 40 weeks on treatment.
Positive numbers reflect the reduction in the value from baseline to study endpoint as a percent of the baseline.
Reduction in this variable is believed to be associated with lower cardiovascular risk.
measure: Absolute Reduction in Visceral Adipose Tissue Volume
time frame: Baseline, 40 weeks
description: The effect on absolute reduction from baseline in visceral adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo.
Positive numbers reflect the reduction in the value from baseline to study endpoint.
Reduction in this variable is believed to be associated with lower cardiovascular risk.
measure: Relative Percent Reduction in Body Weight
time frame: Baseline, 40 weeks
description: The effect on relative percent reduction from baseline in body weight after 40 weeks on treatment versus placebo.
Positive numbers reflect the reduction in the value from baseline to study endpoint.
Reduction in this variable is believed to be associated with lower cardiovascular risk.
measure: Absolute Reduction in Body Weight
time frame: Baseline, 40 weeks
description: The effect on absolute reduction from baseline in body weight after 40 weeks on treatment versus placebo.
Positive numbers reflect the reduction in the value from baseline to study endpoint.
Reduction in this variable is believed to be associated with lower cardiovascular risk.
measure: Relative Percent Reduction in Waist Circumference
time frame: Baseline, 40 weeks
description: The effect on relative percent reduction from baseline in waist circumference after 40 weeks on treatment versus placebo.
Positive numbers reflect the reduction in the value from baseline to study endpoint.
Reduction in this variable is believed to be associated with lower cardiovascular risk.
measure: Absolute Reduction in Waist Circumference
time frame: Baseline, 40 weeks
description: The effect on absolute reduction from baseline in waist circumference after 40 weeks on treatment versus placebo.
Positive numbers reflect the reduction in the value from baseline to study endpoint.
Reduction in this variable is believed to be associated with lower cardiovascular risk.
measure: Relative Percent Reduction in Total Body Adipose Tissue
time frame: Baseline, 40 weeks
description: The effect on relative percent reduction from baseline in total body adipose tissue (fat) mass measured by MRI after 40 weeks on treatment versus placebo.
Positive numbers reflect the reduction in the value from baseline to study endpoint.
Reduction in this variable is believed to be associated with lower cardiovascular risk.
measure: Absolute Reduction in Total Body Adipose Tissue
time frame: Baseline, 40 weeks
description: The effect on absolute reduction from baseline in total body adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo.
Positive numbers reflect the reduction in the value from baseline to study endpoint.
Reduction in this variable is believed to be associated with lower cardiovascular risk.
measure: Relative Percent Reduction in Abdominal Subcutaneous Adipose Tissue
time frame: Baseline, 40 weeks
description: The effect on relative percent reduction from baseline in abdominal subcutaneous adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo.
Positive numbers reflect the reduction in the value from baseline to study endpoint.
measure: Absolute Reduction in Abdominal Subcutaneous Adipose Tissue
time frame: Baseline, 40 weeks
description: The effect on absolute reduction from baseline in abdominal subcutaneous adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo.
Positive numbers reflect the reduction in the value from baseline to study endpoint.
measure: Relative Percent Reduction in Lower Body Subcutaneous Adipose Tissue
time frame: Baseline, 40 weeks
description: The effect on relative percent reduction from baseline in lower body subcutaneous adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo.
Positive numbers reflect the reduction in the value from baseline to study endpoint.
measure: Absolute Reduction in Lower Body Subcutaneous Adipose Tissue
time frame: Baseline, 40 weeks
description: The effect on absolute reduction from baseline in lower body subcutaneous adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo.
Positive numbers reflect the reduction in the value from baseline to study endpoint.
measure: Relative Percent Reduction in Liver Fat Percent
time frame: Baseline, 40 weeks
description: The effect on relative percent reduction from baseline in liver (hepatic) fat percentage measured by MRI after 40 weeks on treatment versus placebo.
Positive numbers reflect the reduction in the value from baseline to study endpoint. Negative values reflect an increase in the value from baseline to study endpoint.
Reduction in this variable is believed to be associated with lower cardiovascular risk.
measure: Absolute Reduction in Liver Fat Percent
time frame: Baseline, 40 weeks
description: The effect on absolute reduction from baseline in liver (hepatic) fat percentage measured by MRI after 40 weeks on treatment versus placebo.
Positive numbers reflect the reduction in the value from baseline to study endpoint. Negative values reflect an increase in the value from baseline to study endpoint.
Reduction in this variable is believed to be associated with lower cardiovascular risk.
measure: Relative Percent Reduction in Total Body Lean Volume
time frame: Baseline, 40 weeks
description: The effect on relative percent reduction from baseline in total body lean volume (fat-free mass) measured by MRI after 40 weeks on treatment versus placebo.
Positive numbers reflect the reduction in the value from baseline to study endpoint.
measure: Absolute Reduction in Total Body Lean Volume
time frame: Baseline, 40 weeks
description: The effect on absolute reduction from baseline in total body lean volume (fat-free mass) measured by MRI after 40 weeks on treatment versus placebo.
Positive numbers reflect the reduction in the value from baseline to study endpoint.
measure: Relative Percent Reduction in Total Thigh Muscle Volume
time frame: Baseline, 40 weeks
description: The effect on relative percent reduction from baseline in total thigh muscle volume measured by MRI after 40 weeks on treatment versus placebo.
Positive numbers reflect the reduction in the value from baseline to study endpoint.
measure: Absolute Reduction in Total Thigh Muscle Volume
time frame: Baseline, 40 weeks
description: The effect on absolute reduction from baseline in total thigh muscle volume measured by MRI after 40 weeks on treatment versus placebo.
Positive numbers reflect the reduction in the value from baseline to study endpoint.
measure: Relative Percent Reduction in Mean Anterior Thigh Muscle Fat Infiltration Percent
time frame: Baseline,40 weeks
description: The effect on relative percent reduction from baseline in mean anterior thigh muscle fat infiltration percent measured by MRI after 40 weeks on treatment versus placebo.
Positive numbers reflect the reduction in the value from baseline to study endpoint. Negative values reflect an increase in the value from baseline to study endpoint.
Reduction in this variable is believed to be associated with lower risk for metabolic disease.
measure: Absolute Reduction in Mean Anterior Thigh Muscle Fat Infiltration Percent
time frame: Baseline,40 weeks
description: The effect on absolute reduction from baseline in mean anterior thigh muscle fat infiltration percent measured by MRI after 40 weeks on treatment versus placebo.
Positive numbers reflect the reduction in the value from baseline to study endpoint. Negative values reflect an increase in the value from baseline to study endpoint.
Reduction in this variable is believed to be associated with lower risk for metabolic disease
measure: Change From Baseline in VAT/SAT Ratio
time frame: Baseline, 40 weeks
description: The effect on absolute reduction from baseline in Visceral adipose tissue/subcutaneous adipose tissue (VAT/SAT) ratio measured by MRI after 40 weeks on treatment versus placebo.
Positive numbers reflect the reduction in the value from baseline to study endpoint.
This is the ratio of visceral adipose tissue to subcutaneous adipose tissue and it is thought that lower values (relatively less visceral adipose tissue) are better.
measure: Change From Baseline in Total Fat/Fat-free Mass Ratio
time frame: Baseline, 40 weeks
description: The effect on absolute change from baseline in total fat/fat-free mass ratio measured by MRI after 40 weeks on treatment versus placebo.
This is a ratio of fat to lean mass and it is believed that lower values (less fat relative to lean mass) is better.
measure: Relative Percent Change in Fasting Blood Glucose
time frame: Baseline, 40 weeks
description: The relative percent change in fasting blood glucose from baseline to study end point as a percent of baseline by treatment group.
Negative values reflect a reduction. This is a blood based biomarker for diabetes in which normal levels are desirable (70-100 mg/dL).
measure: Relative Percent Change in Insulin
time frame: Baseline, 40 weeks
description: The relative percent change in insulin from baseline to study end point as a percent of baseline by treatment group.
Positive values reflect an increase. Collection was impacted by coronavirus disease 2019 (COVID-19) and limitations to in person study visits, limiting complete collection of data for this measure.
This is a blood based biomarker in which lower fasting levels are desirable.
measure: Relative Percent Change in HOMA-IR
time frame: Baseline, 40 weeks
description: The relative percent change in HOMA-IR from baseline to study end point as a percent of baseline by treatment group.
Positive values reflect an increase. Collection was impacted by coronavirus disease 2019 (COVID-19) and limitations to in person study visits, limiting complete collection of data for this measure.
The relative percent change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) from baseline to study end point by treatment group measures insulin resistance. Levels above 1.9 signal early insulin resistance, while levels above 2.9 signal significant insulin resistance. There will be optimal insulin sensitivity if HOMA-IR is less than 1.
measure: Relative Percent Change in C-reactive Protein
time frame: Baseline, 40 weeks
description: The relative percent change in biomarker of inflammation: C-reactive protein (CRP) from baseline to study end point as a percent of baseline by treatment group.
Negative values reflect a decrease. Collection was impacted by coronavirus disease 2019 (COVID-19) and limitations to in person study visits, limiting complete collection of data for this measure.
This is a blood based test for which lower values are associated with less inflammation and lower risk for cardiovascular events.
measure: Relative Percent Change in Triglyceride/HDL-C Ratio
time frame: Baseline, 40 weeks
description: The relative percent change in triglyceride/HDL-C ratio from baseline to study end point as a percent of baseline by treatment group.
Negative values reflect a decrease. Collection was impacted by coronavirus disease 2019 (COVID-19) and limitations to in person study visits, limiting complete collection of data for this measure.
Lower ratio of triglycerides to HDL-cholesterol is associated with less insulin resistance and lower cardiovascular risk.
measure: Relative Percent Change in Nt-proBNP
time frame: Baseline, 40 weeks
description: The relative percent change in N-terminal Pro Brain Natriuretic Peptides (Nt-proBNP) from baseline to study end point as a percent of baseline by treatment group.
Negative values reflect a decrease. Collection was impacted by coronavirus disease 2019 (COVID-19) and limitations to in person study visits, limiting complete collection of data for this measure.
NT-proBNP is a blood based biomarker. Lower levels are associated with lower risk for heart failure and cardiovascular events.
measure: Absolute Change in Fasting Blood Glucose
time frame: Baseline,40 weeks
description: The change in fasting blood glucose from baseline to study end point by treatment group.
measure: Absolute Change in Insulin
time frame: Baseline, 40 weeks
description: The absolute change in insulin from baseline to study end point by treatment group. Collection was impacted by COVID-19 and changes to study visits.
measure: Absolute Change in HOMA-IR
time frame: Baseline, 40 weeks
description: The absolute change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) from baseline to study end point by treatment group measures insulin resistance. Levels above 1.9 signal early insulin resistance, while levels above 2.9 signal significant insulin resistance. There will be optimal insulin sensitivity if HOMA-IR is less than 1. Collection was impacted by COVID-19 and changes to study visits.
measure: Absolute Change in CRP
time frame: Baseline, 40 weeks
description: The change in Markers of inflammation: C-reactive protein (CRP) from baseline to study end point by treatment group. Collection was impacted by COVID-19 and changes to study visits.
This is a blood based test for which lower values are associated with less inflammation and lower risk for cardiovascular events.
measure: Absolute Change in Triglyceride/HDL-C Ratio
time frame: Baseline, 40 weeks
description: The change in triglyceride/HDL-C ratio from baseline to study end point by treatment group. Collection was impacted by COVID-19 and changes to study visits.
Lower ratio of triglycerides to HDL-cholesterol is associated with less insulin resistance and lower cardiovascular risk.
measure: Absolute Change in Nt-proBNP
time frame: Baseline, 40 weeks
description: The change in N-terminal Pro Brain Natriuretic Peptides (Nt-proBNP) from baseline to study end point by treatment group. Collection was impacted by COVID-19 and changes to study visits.
NT-proBNP is a blood based biomarker. Lower levels are associated with lower risk for heart failure and cardiovascular events.
measure: Change From Baseline in Heart Rate
time frame: Baseline, 40 weeks
description: The change in heart rate/pulse from baseline to study endpoint visit by treatment group.
measure: Change From Baseline in Blood Pressure
time frame: Baseline, 40 weeks
description: The change in systolic blood pressure from baseline to study endpoint visit by treatment group.
measure: On-treatment Time, Weeks
time frame: weeks
description: The mean duration of treatment during study follow-up.
arm group label: Liraglutide 3.0 mg
arm group type: Experimental
description: Drug: Liraglutide Active Drug
Other Names:
Saxenda
Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.
arm group label: Placebo
arm group type: Placebo Comparator
description: Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL
Other Names:
Placebo
Saline injection
Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.
intervention type: Drug
intervention name: Liraglutide
description: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.
arm group label: Liraglutide 3.0 mg
other name: Saxenda
intervention type: Drug
intervention name: Placebo
description: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.
arm group label: Placebo
other name: Saline injection
criteria: 
gender: All
minimum age: 35 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Parag Joshi, MD
role: Principal Investigator
affiliation: University of Texas Southwestern Medical Center
facility: 
country: United States
citation: Astrup A, Rossner S, Van Gaal L, Rissanen A, Niskanen L, Al Hakim M, Madsen J, Rasmussen MF, Lean ME; NN8022-1807 Study Group. Effects of liraglutide in the treatment of obesity: a randomised, double-blind, placebo-controlled study. Lancet. 2009 Nov 7;374(9701):1606-16. doi: 10.1016/S0140-6736(09)61375-1. Epub 2009 Oct 23. Erratum In: Lancet. 2010 Mar 20;375(9719):984.
PMID: 19853906
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responsible party type: Principal Investigator
investigator affiliation: University of Texas Southwestern Medical Center
investigator full name: Parag Joshi
investigator title: M.D.
mesh term: Cardiovascular Diseases
mesh term: Obesity, Abdominal
mesh term: Liraglutide
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Results reported according to updated statistical analysis plan published 7/28/2020 on CT.gov website. The updated 7/28/2020 analysis plan accounted for changes in data collection (blood biomarkers) during COVID-19 pandemic and was submitted and published prior to study completion and prior to study un-blinding with updated terminology for study endpoints compared to original protocol.
point of contact: 