<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/NCT03041792</url>
  </required_header>
  <id_info>
    <org_study_id>A9001498</org_study_id>
    <nct_id>NCT03041792</nct_id>
  </id_info>
  <brief_title>Methodology Study To Examine 6-Week Food Intake With Liraglutide In Obese Subjects</brief_title>
  <official_title>A 6-WEEK, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, TWO-ARM, PARALLEL METHODOLOGY STUDY TO ASSESS THE EFFECT OF LIRAGLUTIDE ON FOOD INTAKE IN OBESE SUBJECTS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This will be a randomized, double blind, placebo controlled, 2 arm, parallel group,&#xD;
      methodology study to assess the effect of 6 weeks of liraglutide administration on food&#xD;
      intake in obese subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 20, 2017</start_date>
  <completion_date type="Actual">January 16, 2018</completion_date>
  <primary_completion_date type="Actual">January 16, 2018</primary_completion_date>
  <phase>Phase 1</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>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline (Visit 3) in Mean Energy Intake During Ad Libitum Lunches at Visits 4 and 5</measure>
    <time_frame>Visit 3, Visit 4 and Visit 5</time_frame>
    <description>The mean energy intake was collected to assess the effect of liraglutide on food intake in non-diabetic, obese participants. Observed food intake was measured as the total number of calories consumed during the specified time period, calculated as the difference of the total number of calories provided minus the total number of calories remaining after meals. Mean energy intakes at Visit 4 was defined as the mean values of the measurements at Study Day 20 and 21. Same definition applies to Visit 5 (Study Day 41 and 42). Baseline was defined as the mean of Visit 3 (Study Day -1 and 0).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Vital Signs Data Meeting Categorical Criteria</measure>
    <time_frame>Baseline (Visit 3) up to Visit 6 (Study Day 53)</time_frame>
    <description>Absolute values and changes from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP), pulse rate (PR) were recorded in supine position. Vital signs categorical summarization criteria were 1), blood pressure: SBP greater than or equal to (&gt;=) 30 millimeters of mercury (mm Hg) change from baseline, SBP less than (&lt;) 90 mm Hg; DBP &gt;=20 mm Hg change from baseline, DBP &lt;50 mm Hg; 2), PR &lt;40 or greater than (&gt;) 120 beats per minute (bpm). Baseline was defined as pre-treatment measurement on Day 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment-Emergent Adverse Events (All-Causality)</measure>
    <time_frame>Baseline (Visit 3) up to 31 days post last dose (75 days)</time_frame>
    <description>Adverse event (AE) was defined as any untoward medical occurrence in a study participant administered a product or medical device, regardless of its causal relationship with study treatment. An AE is considered treatment-emergent relative to a given treatment if: the event occurs for the first time during the effective duration of treatment and was not seen prior to the start of treatment (for example, during the baseline or run-in period); or the event was seen prior to the start of treatment but increased in severity during treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Abnormal 12-lead Electrocardiogram (ECG)</measure>
    <time_frame>Baseline (Visit 3) up to Visit 6 (Study Day 53)</time_frame>
    <description>ECG categorical summarization criteria: 1) PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): absolute value greater than or equal to (&gt;=) 300 msec, percent change &gt;=25% if baseline was greater than (&gt;) 200 msec, and &gt;=50% if baseline was less than or equal to (&lt;=) 200 msec; 2) QRS interval (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): absolute value &gt;=200 msec, percent change &gt;=25% if baseline was 100 msec, and &gt;=50% if baseline was &lt;=100 msec; 3) QTcF interval (QT corrected for heart rate using Fridericia's formula): absolute value &gt;450 to &lt;=480 msec, &gt;480 to &lt;=500 msec, &gt;500 msec, an increase from baseline &gt;30 to &lt;=60 msec or &gt;60 msec. Baseline was defined as pre-treatment measurement on Day -2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)</measure>
    <time_frame>Baseline (Visit 3) up to Visit 6 (Study Day 53)</time_frame>
    <description>Below parameters were evaluated:1), Hematology: hemoglobin (HGB), hematocrit, erythrocytes (absolute value/mean corpuscular volume/mean corpuscular HGB/mean corpuscular HGB concentration), platelets, leukocytes, lymphocytes, neutrophils, basophils, monocytes; 2), clinical chemistry: bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, protein, albumin, blood urea nitrogen, creatinine, cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides, sodium, potassium, chloride, calcium, bicarbonate, amylase, triacylglycerol lipase; 3), urinalysis: pH, urine glucose, ketones, urine protein, urine hemoglobin, urobilinogen, urine bilirubin, nitrite, leukocyte esterase, urine erythrocytes, urine leukocytes, hyaline casts, bacteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Mean 48-hour Energy Intake at Visits 4 and 5</measure>
    <time_frame>Visit 3, Visit 4 (Study Day 20 and 21) and Visit 5 (Study Day 41 and 42)</time_frame>
    <description>Energy intake was measured over a period of 48 hours to assess day to day variability in food intake. Observed food intake was measured as the total number of calories consumed during the specified time period, calculated as the difference of the total number of calories provided minus the total number of calories remaining after meals. Baseline was defined as the 48 hour period at Visit 3 (Study Day -1 and 0).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Appetite Score (Mean Rating Area Under Curve From Time 30 to 120 Minutes [AUC30-120min]) for Mean Lunch at Visits 4 and 5</measure>
    <time_frame>Visit 3, Visit 4 (Study Day 20 and 21) and Visit 5 (Study Day 41 and 42)</time_frame>
    <description>Appetite, satiety, fullness, hunger, and prospective consumption were measured using a validated Visual Analog scale (VAS) questionnaire. VAS was an assessment in which participants place a vertical line across a validated 100 millimeter (mm) line with the example of &quot;Not At All Full&quot; and &quot;Totally Full&quot; at either end, scoring from 0 to 100. The overall appetite score was calculated as the average of the four individual scores [satiety + fullness + (100 - prospective food consumption)+(100 - hunger)] divided by 4. The VAS questionnaire was completed by the participant immediately prior to meal administration, and at 30, 60 and 120 minutes after start of the specified meals. Baseline of Mean Rating AUC30-120min was defined as the rating for mean lunch at Visit 3 (Study Day -1 and 0).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Satiety, Fullness, Prospective Food Consumption and Hunger Scores (Mean Rating AUC30-120min) for Mean Lunch at Visits 4 and 5</measure>
    <time_frame>Visit 3, Visit 4 (Study Day 20 and 21) and Visit 5 (Study Day 41 and 42)</time_frame>
    <description>Satiety, fullness, hunger, and prospective consumption were measured at the study site using a validated VAS questionnaire. The VAS measurement of the subcomponent scores were the same as that of the appetite score. Baseline of Mean Rating AUC30-120min was defined as the rating for mean lunch at Visit 3 (Study Day -1 and 0).The VAS was an assessment in which subjects place a vertical line across a validated 100 millimeter (mm) line to rank their response to various questions. The line was anchored by responses such as &quot;Not At All Full&quot; and &quot;Totally Full&quot; at either end. Scoring consisted of measuring the distance in mm of the vertical line from the response at the left end. The scores (total and subscale) ranged from 0 to 100. The lower values represent the better outcomes.The overall appetite score was calculated as the average of the 4 individual scores [satiety+fullness+(100-prospective food consumption)+(100-hunger)] divided by 4.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Area Under the Plasma Concentration-Time Profile of Acetaminophen for 0-60 Minutes and 0-300 Minutes (AUC0-60min and AUC0-300min) After Acetaminophen Dose at Visits 4 and 5</measure>
    <time_frame>Prior to breakfast and at 30,60,90,120,180 and 300 minutes after intake of the acetaminophen with breakfast on Visit 3,Visit 4 (Study Day 20) and Visit 5 (Study Day 41)</time_frame>
    <description>A non investigational medicinal product (acetaminophen 1.5 gram [g]) was administered as a challenge agent for the assessment of gastric emptying. The blood sampling for determining acetaminophen concentrations was performed at 7 time points: prior to breakfast and at 30, 60, 90, 120, 180 and 300 minutes after intake of the acetaminophen with breakfast. Baseline was calculated at Visit 3 (Study Day -1).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Active</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Liraglutide</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo comparator</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Liraglutide</intervention_name>
    <description>Liraglutide</description>
    <arm_group_label>Active</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males and female subjects;&#xD;
&#xD;
          -  Body Mass Index 30-40 kg/m2;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence of history of clinically significant hematological, renal, endocrine,&#xD;
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or&#xD;
             allergic disease (including drug allergises, but excluding untreated, asymptomatic,&#xD;
             seasonal allergies at time of dosing)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Translational Research Institute for Metabolism and Diabetes</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9001498&amp;StudyName=A+6-WEEK%2C+RANDOMIZED%2C+DOUBLE-BLIND%2C+PLACEBO-CONTROLLED%2C+TWO-ARM%2C+PARALLEL+METHODOLOGY+STUDY+TO+ASSESS+THE+EFFECT+OF+LIRAGLUTIDE+ON+FOOD+INTAKE+IN+OBESE+SUBJECTS</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>February 1, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <results_first_submitted>January 14, 2019</results_first_submitted>
  <results_first_submitted_qc>May 28, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">July 26, 2019</results_first_posted>
  <last_update_submitted>May 28, 2019</last_update_submitted>
  <last_update_submitted_qc>May 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>
    <ipd_description>Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.</ipd_description>
  </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>November 21, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/92/NCT03041792/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 16, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/92/NCT03041792/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Overall, a total of 61 potential participants were randomized to the study, and 60 of them received study treatment.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Liraglutide</title>
          <description>Liraglutide was administered subcutaneously via pen injection with dose titration to 3.0 milligram (mg) daily per Saxenda prescribing instructions.</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>0.9% weight/volume (w/v) sodium chloride, United States Pharmacopeia (USP), was administered subcutaneously as placebo via syringe injection daily with matching volume to liraglutide dose.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
                <participants group_id="P2" count="29"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Treatment</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
                <participants group_id="P2" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
                <participants group_id="P2" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death in the family</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Randomized but not treated</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All participants who met the criteria stated below were included in the full analysis set (FAS): completed baseline assessment of food intake; received at least one dose of randomized, blinded investigational product (IP); and completed at least one post baseline measurement (after taking randomized IP).</population>
      <group_list>
        <group group_id="B1">
          <title>Liraglutide</title>
          <description>Liraglutide was administered subcutaneously via pen injection with dose titration to 3.0 milligram (mg) daily per Saxenda prescribing instructions.</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>0.9% weight/volume (w/v) sodium chloride, United States Pharmacopeia (USP), was administered subcutaneously as placebo via syringe injection daily with matching volume to liraglutide dose.</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="30"/>
            <count group_id="B2" value="26"/>
            <count group_id="B3" value="56"/>
          </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="43.0" spread="10.88"/>
                    <measurement group_id="B2" value="48.1" spread="12.63"/>
                    <measurement group_id="B3" value="45.4" spread="11.89"/>
                  </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="22"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <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>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>Other</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</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_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline (Visit 3) in Mean Energy Intake During Ad Libitum Lunches at Visits 4 and 5</title>
        <description>The mean energy intake was collected to assess the effect of liraglutide on food intake in non-diabetic, obese participants. Observed food intake was measured as the total number of calories consumed during the specified time period, calculated as the difference of the total number of calories provided minus the total number of calories remaining after meals. Mean energy intakes at Visit 4 was defined as the mean values of the measurements at Study Day 20 and 21. Same definition applies to Visit 5 (Study Day 41 and 42). Baseline was defined as the mean of Visit 3 (Study Day -1 and 0).</description>
        <time_frame>Visit 3, Visit 4 and Visit 5</time_frame>
        <population>Number of participants analyzed includes participants who met the criteria: completed baseline assessment of food intake;received at least 1 dose of randomized, blinded IP;completed at least 1 post baseline measurement(after taking randomized IP).Number analyzed includes participants contributing to mean energy intake at specified visits.</population>
        <group_list>
          <group group_id="O1">
            <title>Liraglutide</title>
            <description>Liraglutide was administered subcutaneously via pen injection with dose titration to 3.0 milligram (mg) daily per Saxenda prescribing instructions.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>0.9% weight/volume (w/v) sodium chloride, United States Pharmacopeia (USP), was administered subcutaneously as placebo via syringe injection daily with matching volume to liraglutide dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline (Visit 3) in Mean Energy Intake During Ad Libitum Lunches at Visits 4 and 5</title>
          <description>The mean energy intake was collected to assess the effect of liraglutide on food intake in non-diabetic, obese participants. Observed food intake was measured as the total number of calories consumed during the specified time period, calculated as the difference of the total number of calories provided minus the total number of calories remaining after meals. Mean energy intakes at Visit 4 was defined as the mean values of the measurements at Study Day 20 and 21. Same definition applies to Visit 5 (Study Day 41 and 42). Baseline was defined as the mean of Visit 3 (Study Day -1 and 0).</description>
          <population>Number of participants analyzed includes participants who met the criteria: completed baseline assessment of food intake;received at least 1 dose of randomized, blinded IP;completed at least 1 post baseline measurement(after taking randomized IP).Number analyzed includes participants contributing to mean energy intake at specified visits.</population>
          <units>kilocalories (kcal)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-254.48" spread="160.67"/>
                    <measurement group_id="O2" value="-19.93" spread="162.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-278.78" spread="190.09"/>
                    <measurement group_id="O2" value="-37.43" spread="164.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Visit 4</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0000</p_value>
            <p_value_desc>The p-value was calculated and was rounded to 4th decimal presenting as 0.0000, which was smaller than the required threshold of &lt;0.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>-235.75</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>43.13</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-322.25</ci_lower_limit>
            <ci_upper_limit>-149.25</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Visit 5</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0000</p_value>
            <p_value_desc>The p-value was calculated and was rounded to 4th decimal presenting as 0.0000, which was smaller than the required threshold of &lt;0.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>-243.63</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>47.60</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-339.10</ci_lower_limit>
            <ci_upper_limit>-148.15</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Vital Signs Data Meeting Categorical Criteria</title>
        <description>Absolute values and changes from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP), pulse rate (PR) were recorded in supine position. Vital signs categorical summarization criteria were 1), blood pressure: SBP greater than or equal to (&gt;=) 30 millimeters of mercury (mm Hg) change from baseline, SBP less than (&lt;) 90 mm Hg; DBP &gt;=20 mm Hg change from baseline, DBP &lt;50 mm Hg; 2), PR &lt;40 or greater than (&gt;) 120 beats per minute (bpm). Baseline was defined as pre-treatment measurement on Day 1.</description>
        <time_frame>Baseline (Visit 3) up to Visit 6 (Study Day 53)</time_frame>
        <population>All participants who received at least 1 dose of study medication classified according to the actual study treatment received. Follow-up readings have been excluded from presentation, and 4 participants have been excluded from presentation because they only have follow up readings in post-dose phase.</population>
        <group_list>
          <group group_id="O1">
            <title>Liraglutide</title>
            <description>Liraglutide was administered subcutaneously via pen injection with dose titration to 3.0 milligram (mg) daily per Saxenda prescribing instructions.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>0.9% weight/volume (w/v) sodium chloride, United States Pharmacopeia (USP), was administered subcutaneously as placebo via syringe injection daily with matching volume to liraglutide dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Vital Signs Data Meeting Categorical Criteria</title>
          <description>Absolute values and changes from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP), pulse rate (PR) were recorded in supine position. Vital signs categorical summarization criteria were 1), blood pressure: SBP greater than or equal to (&gt;=) 30 millimeters of mercury (mm Hg) change from baseline, SBP less than (&lt;) 90 mm Hg; DBP &gt;=20 mm Hg change from baseline, DBP &lt;50 mm Hg; 2), PR &lt;40 or greater than (&gt;) 120 beats per minute (bpm). Baseline was defined as pre-treatment measurement on Day 1.</description>
          <population>All participants who received at least 1 dose of study medication classified according to the actual study treatment received. Follow-up readings have been excluded from presentation, and 4 participants have been excluded from presentation because they only have follow up readings in post-dose phase.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Supine DBP &lt;50 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Supine PR &lt;40 bpm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Supine PR &gt;120 bpm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Supine SBP &lt;90 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Increase in supine DBP &gt;=20 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Increase in supine SBP &gt;=30 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Decrease in supine DBP &gt;=20 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Decrease in supine SBP &gt;=30 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment-Emergent Adverse Events (All-Causality)</title>
        <description>Adverse event (AE) was defined as any untoward medical occurrence in a study participant administered a product or medical device, regardless of its causal relationship with study treatment. An AE is considered treatment-emergent relative to a given treatment if: the event occurs for the first time during the effective duration of treatment and was not seen prior to the start of treatment (for example, during the baseline or run-in period); or the event was seen prior to the start of treatment but increased in severity during treatment.</description>
        <time_frame>Baseline (Visit 3) up to 31 days post last dose (75 days)</time_frame>
        <population>The safety analysis population included all participants who received at least one dose of study medication classified according to the actual study treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>Liraglutide</title>
            <description>Liraglutide was administered subcutaneously via pen injection with dose titration to 3.0 milligram (mg) daily per Saxenda prescribing instructions.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>0.9% weight/volume (w/v) sodium chloride, United States Pharmacopeia (USP), was administered subcutaneously as placebo via syringe injection daily with matching volume to liraglutide dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-Emergent Adverse Events (All-Causality)</title>
          <description>Adverse event (AE) was defined as any untoward medical occurrence in a study participant administered a product or medical device, regardless of its causal relationship with study treatment. An AE is considered treatment-emergent relative to a given treatment if: the event occurs for the first time during the effective duration of treatment and was not seen prior to the start of treatment (for example, during the baseline or run-in period); or the event was seen prior to the start of treatment but increased in severity during treatment.</description>
          <population>The safety analysis population included all participants who received at least one dose of study medication classified according to the actual study treatment received.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Abnormal 12-lead Electrocardiogram (ECG)</title>
        <description>ECG categorical summarization criteria: 1) PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): absolute value greater than or equal to (&gt;=) 300 msec, percent change &gt;=25% if baseline was greater than (&gt;) 200 msec, and &gt;=50% if baseline was less than or equal to (&lt;=) 200 msec; 2) QRS interval (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): absolute value &gt;=200 msec, percent change &gt;=25% if baseline was 100 msec, and &gt;=50% if baseline was &lt;=100 msec; 3) QTcF interval (QT corrected for heart rate using Fridericia's formula): absolute value &gt;450 to &lt;=480 msec, &gt;480 to &lt;=500 msec, &gt;500 msec, an increase from baseline &gt;30 to &lt;=60 msec or &gt;60 msec. Baseline was defined as pre-treatment measurement on Day -2.</description>
        <time_frame>Baseline (Visit 3) up to Visit 6 (Study Day 53)</time_frame>
        <population>All participants who received at least one dose of study medication classified according to the actual study treatment received. Follow-up readings have been excluded from presentation, and 4 participants have been excluded from presentation because they only have follow up readings in post-dose phase.</population>
        <group_list>
          <group group_id="O1">
            <title>Liraglutide</title>
            <description>Liraglutide was administered subcutaneously via pen injection with dose titration to 3.0 milligram (mg) daily per Saxenda prescribing instructions.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>0.9% weight/volume (w/v) sodium chloride, United States Pharmacopeia (USP), was administered subcutaneously as placebo via syringe injection daily with matching volume to liraglutide dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal 12-lead Electrocardiogram (ECG)</title>
          <description>ECG categorical summarization criteria: 1) PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): absolute value greater than or equal to (&gt;=) 300 msec, percent change &gt;=25% if baseline was greater than (&gt;) 200 msec, and &gt;=50% if baseline was less than or equal to (&lt;=) 200 msec; 2) QRS interval (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): absolute value &gt;=200 msec, percent change &gt;=25% if baseline was 100 msec, and &gt;=50% if baseline was &lt;=100 msec; 3) QTcF interval (QT corrected for heart rate using Fridericia's formula): absolute value &gt;450 to &lt;=480 msec, &gt;480 to &lt;=500 msec, &gt;500 msec, an increase from baseline &gt;30 to &lt;=60 msec or &gt;60 msec. Baseline was defined as pre-treatment measurement on Day -2.</description>
          <population>All participants who received at least one dose of study medication classified according to the actual study treatment received. Follow-up readings have been excluded from presentation, and 4 participants have been excluded from presentation because they only have follow up readings in post-dose phase.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PR interval &gt;=300 milliseconds (msec)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QRS interval &gt;=200 msec</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcF &gt;450 - &lt;=480 msec</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcF &gt;480 - &lt;=500 msec</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcF &gt;500 msec</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PR interval percent increase &gt;=25/50%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QRS interval percent increase &gt;=25/50%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcF increase &gt;30 - &lt;=60 msec</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcF increase &gt;60 msec</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)</title>
        <description>Below parameters were evaluated:1), Hematology: hemoglobin (HGB), hematocrit, erythrocytes (absolute value/mean corpuscular volume/mean corpuscular HGB/mean corpuscular HGB concentration), platelets, leukocytes, lymphocytes, neutrophils, basophils, monocytes; 2), clinical chemistry: bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, protein, albumin, blood urea nitrogen, creatinine, cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides, sodium, potassium, chloride, calcium, bicarbonate, amylase, triacylglycerol lipase; 3), urinalysis: pH, urine glucose, ketones, urine protein, urine hemoglobin, urobilinogen, urine bilirubin, nitrite, leukocyte esterase, urine erythrocytes, urine leukocytes, hyaline casts, bacteria.</description>
        <time_frame>Baseline (Visit 3) up to Visit 6 (Study Day 53)</time_frame>
        <population>All participants who received at least one dose of study medication classified according to the actual study treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>Liraglutide</title>
            <description>Liraglutide was administered subcutaneously via pen injection with dose titration to 3.0 milligram (mg) daily per Saxenda prescribing instructions.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>0.9% weight/volume (w/v) sodium chloride, United States Pharmacopeia (USP), was administered subcutaneously as placebo via syringe injection daily with matching volume to liraglutide dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)</title>
          <description>Below parameters were evaluated:1), Hematology: hemoglobin (HGB), hematocrit, erythrocytes (absolute value/mean corpuscular volume/mean corpuscular HGB/mean corpuscular HGB concentration), platelets, leukocytes, lymphocytes, neutrophils, basophils, monocytes; 2), clinical chemistry: bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, protein, albumin, blood urea nitrogen, creatinine, cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides, sodium, potassium, chloride, calcium, bicarbonate, amylase, triacylglycerol lipase; 3), urinalysis: pH, urine glucose, ketones, urine protein, urine hemoglobin, urobilinogen, urine bilirubin, nitrite, leukocyte esterase, urine erythrocytes, urine leukocytes, hyaline casts, bacteria.</description>
          <population>All participants who received at least one dose of study medication classified according to the actual study treatment received.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Mean 48-hour Energy Intake at Visits 4 and 5</title>
        <description>Energy intake was measured over a period of 48 hours to assess day to day variability in food intake. Observed food intake was measured as the total number of calories consumed during the specified time period, calculated as the difference of the total number of calories provided minus the total number of calories remaining after meals. Baseline was defined as the 48 hour period at Visit 3 (Study Day -1 and 0).</description>
        <time_frame>Visit 3, Visit 4 (Study Day 20 and 21) and Visit 5 (Study Day 41 and 42)</time_frame>
        <population>Number of participants analyzed includes participants who met the criteria: completed baseline assessment of food intake;received at least 1 dose of randomized, blinded IP;completed at least 1 post baseline measurement(after taking randomized IP).Number analyzed includes participants contributing to mean 48-hour energy intake at specified visits.</population>
        <group_list>
          <group group_id="O1">
            <title>Liraglutide</title>
            <description>Liraglutide was administered subcutaneously via pen injection with dose titration to 3.0 milligram (mg) daily per Saxenda prescribing instructions.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>0.9% weight/volume (w/v) sodium chloride, United States Pharmacopeia (USP), was administered subcutaneously as placebo via syringe injection daily with matching volume to liraglutide dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Mean 48-hour Energy Intake at Visits 4 and 5</title>
          <description>Energy intake was measured over a period of 48 hours to assess day to day variability in food intake. Observed food intake was measured as the total number of calories consumed during the specified time period, calculated as the difference of the total number of calories provided minus the total number of calories remaining after meals. Baseline was defined as the 48 hour period at Visit 3 (Study Day -1 and 0).</description>
          <population>Number of participants analyzed includes participants who met the criteria: completed baseline assessment of food intake;received at least 1 dose of randomized, blinded IP;completed at least 1 post baseline measurement(after taking randomized IP).Number analyzed includes participants contributing to mean 48-hour energy intake at specified visits.</population>
          <units>kcal</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1058.8" spread="627.61"/>
                    <measurement group_id="O2" value="-205.64" spread="608.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1152.5" spread="745.71"/>
                    <measurement group_id="O2" value="-242.84" spread="681.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Visit 4</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0000</p_value>
            <p_value_desc>The p-value was calculated and was rounded to 4th decimal presenting as 0.0000, which was smaller than the required threshold of &lt;0.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>-859.58</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>167.76</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1196.1</ci_lower_limit>
            <ci_upper_limit>-523.10</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Visit 5</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0000</p_value>
            <p_value_desc>The p-value was calculated and was rounded to 4th decimal presenting as 0.0000, which was smaller than the required threshold of &lt;0.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>-928.56</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>193.80</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1317.3</ci_lower_limit>
            <ci_upper_limit>-539.86</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Appetite Score (Mean Rating Area Under Curve From Time 30 to 120 Minutes [AUC30-120min]) for Mean Lunch at Visits 4 and 5</title>
        <description>Appetite, satiety, fullness, hunger, and prospective consumption were measured using a validated Visual Analog scale (VAS) questionnaire. VAS was an assessment in which participants place a vertical line across a validated 100 millimeter (mm) line with the example of &quot;Not At All Full&quot; and &quot;Totally Full&quot; at either end, scoring from 0 to 100. The overall appetite score was calculated as the average of the four individual scores [satiety + fullness + (100 - prospective food consumption)+(100 - hunger)] divided by 4. The VAS questionnaire was completed by the participant immediately prior to meal administration, and at 30, 60 and 120 minutes after start of the specified meals. Baseline of Mean Rating AUC30-120min was defined as the rating for mean lunch at Visit 3 (Study Day -1 and 0).</description>
        <time_frame>Visit 3, Visit 4 (Study Day 20 and 21) and Visit 5 (Study Day 41 and 42)</time_frame>
        <population>Number of participants analyzed includes participants who met the criteria: completed baseline assessment of food intake;received at least 1 dose of randomized, blinded IP;completed at least 1 post baseline measurement(after taking randomized IP).Number analyzed includes participants contributing to appetite score at specified visits.</population>
        <group_list>
          <group group_id="O1">
            <title>Liraglutide</title>
            <description>Liraglutide was administered subcutaneously via pen injection with dose titration to 3.0 milligram (mg) daily per Saxenda prescribing instructions.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>0.9% weight/volume (w/v) sodium chloride, United States Pharmacopeia (USP), was administered subcutaneously as placebo via syringe injection daily with matching volume to liraglutide dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Appetite Score (Mean Rating Area Under Curve From Time 30 to 120 Minutes [AUC30-120min]) for Mean Lunch at Visits 4 and 5</title>
          <description>Appetite, satiety, fullness, hunger, and prospective consumption were measured using a validated Visual Analog scale (VAS) questionnaire. VAS was an assessment in which participants place a vertical line across a validated 100 millimeter (mm) line with the example of &quot;Not At All Full&quot; and &quot;Totally Full&quot; at either end, scoring from 0 to 100. The overall appetite score was calculated as the average of the four individual scores [satiety + fullness + (100 - prospective food consumption)+(100 - hunger)] divided by 4. The VAS questionnaire was completed by the participant immediately prior to meal administration, and at 30, 60 and 120 minutes after start of the specified meals. Baseline of Mean Rating AUC30-120min was defined as the rating for mean lunch at Visit 3 (Study Day -1 and 0).</description>
          <population>Number of participants analyzed includes participants who met the criteria: completed baseline assessment of food intake;received at least 1 dose of randomized, blinded IP;completed at least 1 post baseline measurement(after taking randomized IP).Number analyzed includes participants contributing to appetite score at specified visits.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.52" spread="8.65"/>
                    <measurement group_id="O2" value="-0.60" spread="9.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.13" spread="9.99"/>
                    <measurement group_id="O2" value="-0.99" spread="8.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Visit 4</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0263</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>4.95</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.16</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.61</ci_lower_limit>
            <ci_upper_limit>9.29</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Visit 5</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0121</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>5.35</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.06</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.22</ci_lower_limit>
            <ci_upper_limit>9.48</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Satiety, Fullness, Prospective Food Consumption and Hunger Scores (Mean Rating AUC30-120min) for Mean Lunch at Visits 4 and 5</title>
        <description>Satiety, fullness, hunger, and prospective consumption were measured at the study site using a validated VAS questionnaire. The VAS measurement of the subcomponent scores were the same as that of the appetite score. Baseline of Mean Rating AUC30-120min was defined as the rating for mean lunch at Visit 3 (Study Day -1 and 0).The VAS was an assessment in which subjects place a vertical line across a validated 100 millimeter (mm) line to rank their response to various questions. The line was anchored by responses such as &quot;Not At All Full&quot; and &quot;Totally Full&quot; at either end. Scoring consisted of measuring the distance in mm of the vertical line from the response at the left end. The scores (total and subscale) ranged from 0 to 100. The lower values represent the better outcomes.The overall appetite score was calculated as the average of the 4 individual scores [satiety+fullness+(100-prospective food consumption)+(100-hunger)] divided by 4.</description>
        <time_frame>Visit 3, Visit 4 (Study Day 20 and 21) and Visit 5 (Study Day 41 and 42)</time_frame>
        <population>Number of participants analyzed includes participants who met the criteria: completed baseline assessment of food intake;received at least 1 dose of randomized, blinded IP;completed at least 1 post baseline measurement(after taking randomized IP).Number analyzed includes participants contributing to VAS scores at specified visits.</population>
        <group_list>
          <group group_id="O1">
            <title>Liraglutide</title>
            <description>Liraglutide was administered subcutaneously via pen injection with dose titration to 3.0 milligram (mg) daily per Saxenda prescribing instructions.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>0.9% weight/volume (w/v) sodium chloride, United States Pharmacopeia (USP), was administered subcutaneously as placebo via syringe injection daily with matching volume to liraglutide dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Satiety, Fullness, Prospective Food Consumption and Hunger Scores (Mean Rating AUC30-120min) for Mean Lunch at Visits 4 and 5</title>
          <description>Satiety, fullness, hunger, and prospective consumption were measured at the study site using a validated VAS questionnaire. The VAS measurement of the subcomponent scores were the same as that of the appetite score. Baseline of Mean Rating AUC30-120min was defined as the rating for mean lunch at Visit 3 (Study Day -1 and 0).The VAS was an assessment in which subjects place a vertical line across a validated 100 millimeter (mm) line to rank their response to various questions. The line was anchored by responses such as &quot;Not At All Full&quot; and &quot;Totally Full&quot; at either end. Scoring consisted of measuring the distance in mm of the vertical line from the response at the left end. The scores (total and subscale) ranged from 0 to 100. The lower values represent the better outcomes.The overall appetite score was calculated as the average of the 4 individual scores [satiety+fullness+(100-prospective food consumption)+(100-hunger)] divided by 4.</description>
          <population>Number of participants analyzed includes participants who met the criteria: completed baseline assessment of food intake;received at least 1 dose of randomized, blinded IP;completed at least 1 post baseline measurement(after taking randomized IP).Number analyzed includes participants contributing to VAS scores at specified visits.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Satiety (Visit 4)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.94" spread="13.50"/>
                    <measurement group_id="O2" value="-0.55" spread="10.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Satiety (Visit 5)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.51" spread="11.79"/>
                    <measurement group_id="O2" value="1.02" spread="9.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fullness (Visit 4)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.04" spread="9.52"/>
                    <measurement group_id="O2" value="1.88" spread="10.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fullness (Visit 5)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.40" spread="10.08"/>
                    <measurement group_id="O2" value="1.89" spread="9.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prospective food consumption (Visit 4)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.74" spread="12.87"/>
                    <measurement group_id="O2" value="1.59" spread="12.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prospective food consumption (Visit 5)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.18" spread="16.92"/>
                    <measurement group_id="O2" value="4.23" spread="14.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hunger (Visit 4)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.71" spread="7.97"/>
                    <measurement group_id="O2" value="2.13" spread="10.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hunger (Visit 5)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.41" spread="8.96"/>
                    <measurement group_id="O2" value="2.63" spread="13.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Satiety (Visit 4)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1768</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>3.98</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.91</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.85</ci_lower_limit>
            <ci_upper_limit>9.82</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Satiety (Visit 5)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1137</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>3.43</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.13</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.85</ci_lower_limit>
            <ci_upper_limit>7.70</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Fullness (Visit 4)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1858</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>2.85</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.12</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.41</ci_lower_limit>
            <ci_upper_limit>7.11</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Fullness (Visit 5)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5288</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>1.41</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.22</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.05</ci_lower_limit>
            <ci_upper_limit>5.86</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Prospective food consumption (Visit 4)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0054</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>-8.46</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.91</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-14.30</ci_lower_limit>
            <ci_upper_limit>-2.61</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Prospective food consumption (Visit 5)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0117</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>-9.78</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.75</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-17.29</ci_lower_limit>
            <ci_upper_limit>-2.27</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Hunger (Visit 4)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0093</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>-6.58</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.44</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-11.48</ci_lower_limit>
            <ci_upper_limit>-1.69</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Hunger (Visit 5)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0296</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>-6.39</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.86</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12.12</ci_lower_limit>
            <ci_upper_limit>-0.66</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Area Under the Plasma Concentration-Time Profile of Acetaminophen for 0-60 Minutes and 0-300 Minutes (AUC0-60min and AUC0-300min) After Acetaminophen Dose at Visits 4 and 5</title>
        <description>A non investigational medicinal product (acetaminophen 1.5 gram [g]) was administered as a challenge agent for the assessment of gastric emptying. The blood sampling for determining acetaminophen concentrations was performed at 7 time points: prior to breakfast and at 30, 60, 90, 120, 180 and 300 minutes after intake of the acetaminophen with breakfast. Baseline was calculated at Visit 3 (Study Day -1).</description>
        <time_frame>Prior to breakfast and at 30,60,90,120,180 and 300 minutes after intake of the acetaminophen with breakfast on Visit 3,Visit 4 (Study Day 20) and Visit 5 (Study Day 41)</time_frame>
        <population>Number of participants analyzed includes participants who met the criteria: completed baseline assessment of food intake;received at least 1 dose of randomized, blinded IP;completed at least 1 post baseline measurement(after taking randomized IP).Number analyzed includes participants contributing to AUC0-60min and AUC0-300min at specified visits.</population>
        <group_list>
          <group group_id="O1">
            <title>Liraglutide</title>
            <description>Liraglutide was administered subcutaneously via pen injection with dose titration to 3.0 milligram (mg) daily per Saxenda prescribing instructions.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>0.9% weight/volume (w/v) sodium chloride, United States Pharmacopeia (USP), was administered subcutaneously as placebo via syringe injection daily with matching volume to liraglutide dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Area Under the Plasma Concentration-Time Profile of Acetaminophen for 0-60 Minutes and 0-300 Minutes (AUC0-60min and AUC0-300min) After Acetaminophen Dose at Visits 4 and 5</title>
          <description>A non investigational medicinal product (acetaminophen 1.5 gram [g]) was administered as a challenge agent for the assessment of gastric emptying. The blood sampling for determining acetaminophen concentrations was performed at 7 time points: prior to breakfast and at 30, 60, 90, 120, 180 and 300 minutes after intake of the acetaminophen with breakfast. Baseline was calculated at Visit 3 (Study Day -1).</description>
          <population>Number of participants analyzed includes participants who met the criteria: completed baseline assessment of food intake;received at least 1 dose of randomized, blinded IP;completed at least 1 post baseline measurement(after taking randomized IP).Number analyzed includes participants contributing to AUC0-60min and AUC0-300min at specified visits.</population>
          <units>microgram*minute/milliliter (ug*min/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="30"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AUC0-60min (Visit 4)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.30" spread="204.93"/>
                    <measurement group_id="O2" value="-4.55" spread="262.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AUC0-60min (Visit 5)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.19" spread="166.47"/>
                    <measurement group_id="O2" value="-8.28" spread="258.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AUC0-300min (Visit 4)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="197.79" spread="491.11"/>
                    <measurement group_id="O2" value="-12.92" spread="489.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AUC0-300min (Visit 5)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="394.22" spread="401.62"/>
                    <measurement group_id="O2" value="47.31" spread="564.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>AUC0-60min (Visit 4)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5008</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>35.56</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>52.46</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-69.64</ci_lower_limit>
            <ci_upper_limit>140.76</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>AUC0-60min (Visit 5)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0348</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>106.15</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>48.95</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>7.86</ci_lower_limit>
            <ci_upper_limit>204.44</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>AUC0-300min (Visit 4)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1040</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>214.24</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>129.48</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-45.59</ci_lower_limit>
            <ci_upper_limit>474.07</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>AUC0-300min (Visit 5)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0152</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>348.43</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>138.29</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>70.20</ci_lower_limit>
            <ci_upper_limit>626.66</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.</time_frame>
      <desc>The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.</desc>
      <group_list>
        <group group_id="E1">
          <title>Liraglutide</title>
          <description>Liraglutide was administered subcutaneously via pen injection with dose titration to 3.0 milligram (mg) daily per Saxenda prescribing instructions.</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>0.9% weight/volume (w/v) sodium chloride, United States Pharmacopeia (USP), was administered subcutaneously as placebo via syringe injection daily with matching volume to liraglutide dose.</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="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA v20.1</default_vocab>
        <default_assessment>Non-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="30" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Eructation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection site bruising</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Injection site erythema</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Injection site mass</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Injection site pruritus</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Amylase increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </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>Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Pfizer ClinicalTrials.gov Call Center</name_or_title>
      <organization>Pfizer, Inc.</organization>
      <phone>1-800-718-1021</phone>
      <email>ClinicalTrials.gov_Inquiries@pfizer.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03041792
org study id: A9001498
nct id: NCT03041792
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This will be a randomized, double blind, placebo controlled, 2 arm, parallel group,
      methodology study to assess the effect of 6 weeks of liraglutide administration on food
      intake in obese subjects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Change From Baseline (Visit 3) in Mean Energy Intake During Ad Libitum Lunches at Visits 4 and 5
time frame: Visit 3, Visit 4 and Visit 5
description: The mean energy intake was collected to assess the effect of liraglutide on food intake in non-diabetic, obese participants. Observed food intake was measured as the total number of calories consumed during the specified time period, calculated as the difference of the total number of calories provided minus the total number of calories remaining after meals. Mean energy intakes at Visit 4 was defined as the mean values of the measurements at Study Day 20 and 21. Same definition applies to Visit 5 (Study Day 41 and 42). Baseline was defined as the mean of Visit 3 (Study Day -1 and 0).
measure: Number of Participants With Vital Signs Data Meeting Categorical Criteria
time frame: Baseline (Visit 3) up to Visit 6 (Study Day 53)
description: Absolute values and changes from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP), pulse rate (PR) were recorded in supine position. Vital signs categorical summarization criteria were 1), blood pressure: SBP greater than or equal to (>=) 30 millimeters of mercury (mm Hg) change from baseline, SBP less than (<) 90 mm Hg; DBP >=20 mm Hg change from baseline, DBP <50 mm Hg; 2), PR <40 or greater than (>) 120 beats per minute (bpm). Baseline was defined as pre-treatment measurement on Day 1.
measure: Number of Participants With Treatment-Emergent Adverse Events (All-Causality)
time frame: Baseline (Visit 3) up to 31 days post last dose (75 days)
description: Adverse event (AE) was defined as any untoward medical occurrence in a study participant administered a product or medical device, regardless of its causal relationship with study treatment. An AE is considered treatment-emergent relative to a given treatment if: the event occurs for the first time during the effective duration of treatment and was not seen prior to the start of treatment (for example, during the baseline or run-in period); or the event was seen prior to the start of treatment but increased in severity during treatment.
measure: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG)
time frame: Baseline (Visit 3) up to Visit 6 (Study Day 53)
description: ECG categorical summarization criteria: 1) PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): absolute value greater than or equal to (>=) 300 msec, percent change >=25% if baseline was greater than (>) 200 msec, and >=50% if baseline was less than or equal to (<=) 200 msec; 2) QRS interval (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): absolute value >=200 msec, percent change >=25% if baseline was 100 msec, and >=50% if baseline was <=100 msec; 3) QTcF interval (QT corrected for heart rate using Fridericia's formula): absolute value >450 to <=480 msec, >480 to <=500 msec, >500 msec, an increase from baseline >30 to <=60 msec or >60 msec. Baseline was defined as pre-treatment measurement on Day -2.
measure: Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)
time frame: Baseline (Visit 3) up to Visit 6 (Study Day 53)
description: Below parameters were evaluated:1), Hematology: hemoglobin (HGB), hematocrit, erythrocytes (absolute value/mean corpuscular volume/mean corpuscular HGB/mean corpuscular HGB concentration), platelets, leukocytes, lymphocytes, neutrophils, basophils, monocytes; 2), clinical chemistry: bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, protein, albumin, blood urea nitrogen, creatinine, cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides, sodium, potassium, chloride, calcium, bicarbonate, amylase, triacylglycerol lipase; 3), urinalysis: pH, urine glucose, ketones, urine protein, urine hemoglobin, urobilinogen, urine bilirubin, nitrite, leukocyte esterase, urine erythrocytes, urine leukocytes, hyaline casts, bacteria.
measure: Change From Baseline in Mean 48-hour Energy Intake at Visits 4 and 5
time frame: Visit 3, Visit 4 (Study Day 20 and 21) and Visit 5 (Study Day 41 and 42)
description: Energy intake was measured over a period of 48 hours to assess day to day variability in food intake. Observed food intake was measured as the total number of calories consumed during the specified time period, calculated as the difference of the total number of calories provided minus the total number of calories remaining after meals. Baseline was defined as the 48 hour period at Visit 3 (Study Day -1 and 0).
measure: Change From Baseline in Appetite Score (Mean Rating Area Under Curve From Time 30 to 120 Minutes [AUC30-120min]) for Mean Lunch at Visits 4 and 5
time frame: Visit 3, Visit 4 (Study Day 20 and 21) and Visit 5 (Study Day 41 and 42)
description: Appetite, satiety, fullness, hunger, and prospective consumption were measured using a validated Visual Analog scale (VAS) questionnaire. VAS was an assessment in which participants place a vertical line across a validated 100 millimeter (mm) line with the example of "Not At All Full" and "Totally Full" at either end, scoring from 0 to 100. The overall appetite score was calculated as the average of the four individual scores [satiety + fullness + (100 - prospective food consumption)+(100 - hunger)] divided by 4. The VAS questionnaire was completed by the participant immediately prior to meal administration, and at 30, 60 and 120 minutes after start of the specified meals. Baseline of Mean Rating AUC30-120min was defined as the rating for mean lunch at Visit 3 (Study Day -1 and 0).
measure: Change From Baseline in Satiety, Fullness, Prospective Food Consumption and Hunger Scores (Mean Rating AUC30-120min) for Mean Lunch at Visits 4 and 5
time frame: Visit 3, Visit 4 (Study Day 20 and 21) and Visit 5 (Study Day 41 and 42)
description: Satiety, fullness, hunger, and prospective consumption were measured at the study site using a validated VAS questionnaire. The VAS measurement of the subcomponent scores were the same as that of the appetite score. Baseline of Mean Rating AUC30-120min was defined as the rating for mean lunch at Visit 3 (Study Day -1 and 0).The VAS was an assessment in which subjects place a vertical line across a validated 100 millimeter (mm) line to rank their response to various questions. The line was anchored by responses such as "Not At All Full" and "Totally Full" at either end. Scoring consisted of measuring the distance in mm of the vertical line from the response at the left end. The scores (total and subscale) ranged from 0 to 100. The lower values represent the better outcomes.The overall appetite score was calculated as the average of the 4 individual scores [satiety+fullness+(100-prospective food consumption)+(100-hunger)] divided by 4.
measure: Change From Baseline in Area Under the Plasma Concentration-Time Profile of Acetaminophen for 0-60 Minutes and 0-300 Minutes (AUC0-60min and AUC0-300min) After Acetaminophen Dose at Visits 4 and 5
time frame: Prior to breakfast and at 30,60,90,120,180 and 300 minutes after intake of the acetaminophen with breakfast on Visit 3,Visit 4 (Study Day 20) and Visit 5 (Study Day 41)
description: A non investigational medicinal product (acetaminophen 1.5 gram [g]) was administered as a challenge agent for the assessment of gastric emptying. The blood sampling for determining acetaminophen concentrations was performed at 7 time points: prior to breakfast and at 30, 60, 90, 120, 180 and 300 minutes after intake of the acetaminophen with breakfast. Baseline was calculated at Visit 3 (Study Day -1).
arm group label: Active
arm group type: Experimental
description: Liraglutide
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo comparator
intervention type: Drug
intervention name: Liraglutide
description: Liraglutide
arm group label: Active
intervention type: Other
intervention name: Placebo
description: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
facility: 
country: United States
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9001498&StudyName=A+6-WEEK%2C+RANDOMIZED%2C+DOUBLE-BLIND%2C+PLACEBO-CONTROLLED%2C+TWO-ARM%2C+PARALLEL+METHODOLOGY+STUDY+TO+ASSESS+THE+EFFECT+OF+LIRAGLUTIDE+ON+FOOD+INTAKE+IN+OBESE+SUBJECTS
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Liraglutide
sharing ipd: No
ipd description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 