<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/NCT03279731</url>
  </required_header>
  <id_info>
    <org_study_id>827450</org_study_id>
    <nct_id>NCT03279731</nct_id>
  </id_info>
  <brief_title>Binge Eating Liraglutide Intervention</brief_title>
  <acronym>BELIEVE</acronym>
  <official_title>Liraglutide 3.0mg/d for the Treatment of Binge Eating Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kelly Allison</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Novo Nordisk A/S</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pennsylvania</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The study is a 17-week, single-center, double-blind, parallel-group, randomized placebo&#xD;
      controlled trial that will test the efficacy of liraglutide 3.0 mg/d as compared to placebo&#xD;
      in reducing the number of binge episodes per week, achieving remission from binge episodes,&#xD;
      and in changes in body weight, global BED symptom improvement, cognitive restraint of food&#xD;
      intake, dietary disinhibition, perceived hunger, quality of life, and depressed mood at&#xD;
      treatment end.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All applicants will be initially screened by phone and/or electronically to determine whether&#xD;
      they potentially meet eligibility criteria. Those who appear to meet eligibility criteria and&#xD;
      remain interested in the trial will be scheduled for an in-person interview.&#xD;
&#xD;
      The in-person interview will be conducted by a psychologist or Masters' level staff member,&#xD;
      who will obtain informed consent and evaluate subjects' behavioral eligibility (i.e.,&#xD;
      willingness and appropriateness to participate) using structured and semi-structured clinical&#xD;
      interviews including: an examination of the applicants' BED symptoms, their mood,&#xD;
      suicidality, and other general psychopathology. Participants will also be asked to complete&#xD;
      questionnaires assessing eating behavior, demographic characteristics, frequency of specific&#xD;
      eating behaviors related to loss of control, risk of substance dependence with the&#xD;
      consumption of high fat/sugar foods, alexithymia, night eating syndrome, sleep patterns and&#xD;
      quality, and attitudes towards food cravings.&#xD;
&#xD;
      Subjects who remain interested and pass this portion of the assessment will proceed to meet&#xD;
      with the study physician or nurse practitioner, who will obtain a medical history and conduct&#xD;
      a physical examination to determine medical eligibility. Subjects will also have an&#xD;
      electrocardiogram (EKG), fasting blood test, and a urine pregnancy test (for females of child&#xD;
      bearing age) to confirm eligibility.&#xD;
&#xD;
      Upon successful completion of the screening visit, subjects will be asked to eat as they&#xD;
      normally would for 2 weeks. Once per week over these two weeks they will receive a brief&#xD;
      survey through REDcap to assess their binge eating episodes for eligibility.&#xD;
&#xD;
      Subjects who continue to meet eligibility criteria assessed at the screening visit and during&#xD;
      the run-in period will be scheduled for a randomization visit at the Center within 3 weeks of&#xD;
      their screening.&#xD;
&#xD;
      Subjects will be randomly assigned to the two interventions in equal numbers (i.e., 1:1&#xD;
      ratio). The subject's weight, blood pressure, and pulse will then be measured. Following&#xD;
      randomization, all subjects will have a medical visit with the study physician or nurse&#xD;
      practitioner who will instruct them in the use of liraglutide 3.0 (as described later) and&#xD;
      provide the first month's supply of medication.&#xD;
&#xD;
      After randomization, subjects will return at week 1 to assess rate of response. Subjects will&#xD;
      return for study visits every two weeks thereafter, at weeks 3, 5, 7, 9, 11, 13, 15, and 17.&#xD;
&#xD;
      These study visits include a brief medical visit (10-15 minutes) with a physician or nurse&#xD;
      practitioner to monitor their response to the medication or any changes in health. Vitals and&#xD;
      weight will be taken. Additionally, binge episodes, mood, suicidality, and symptom&#xD;
      improvement will be assessed by the psychologist or Masters' level trained study staff.&#xD;
      Participants will be asked also to complete questionnaires assessing quality of life,&#xD;
      obsessions related to food, and food cravings prior to each treatment visit for the secondary&#xD;
      outcomes:&#xD;
&#xD;
      In summary, study visits will consist of the medical visit, completion of written surveys,&#xD;
      review of structured interviews with the study staff and review of medication adverse events.&#xD;
      These visits are expected to last about 30-40 minutes. The study assessments at week 17 will&#xD;
      consist of the previously listed procedures and measures in addition to the questionnaires&#xD;
      and blood tests conducted at baseline.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The study was not meeting recruitment goals.&#xD;
  </why_stopped>
  <start_date type="Actual">September 29, 2017</start_date>
  <completion_date type="Actual">October 1, 2019</completion_date>
  <primary_completion_date type="Actual">September 30, 2019</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Single-center, double-blind, randomized placebo-controlled trial with parallel groups.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Novo Nordisk's Clinical Services (CS) will label, package, and ship the labelled study drugs to the Penn's Investigational Drug Service (IDS). Dr. Rockwell from Penn's IDS service will generate the randomization code using a 1:1 randomization scheme of liraglutide and placebo. The first subject to meet the treatment criteria will be assigned the first number in the sequence; each subsequent subject to meet treatment criteria will be assigned the next number in the sequence. Unblinding of the treatment codes will occur after all data have been verified and deemed clean by the data managers and statistician, and right before analysis of the data occurs.&#xD;
The code for a particular subject may be broken in a medical emergency if knowing the identity of the treatment allocation would influence the treatment of the subject or if demanded by the subject. Whenever a code is broken, the staff-member breaking the code will record the time, date and reason.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Binge Episodes</measure>
    <time_frame>baseline and 17 weeks (or last observation carried forward)</time_frame>
    <description>Change in objective binge episodes per week from randomization (week 0) to study end (week 17)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Remission From Binge-eating</measure>
    <time_frame>13 to 17 weeks</time_frame>
    <description>the percentage of participants (completers) who have achieved remission from binge-eating (no binge episodes between weeks 13 - 17)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Improvement of Binge Eating Symptoms</measure>
    <time_frame>week 17 (or last observation carried forward)</time_frame>
    <description>week 17 rating on the interviewer-based Clinical Global Impression of Improvement (CGII) Scale for global assessment of BED symptoms The CGII includes the following rating scale: Compared to the patient's condition at baseline to the project [prior to medication initiation], this patient's condition is: 1 very much improved; 2 much improved; 3 improved; 4 no change; 5 worse; 6 much worse; 7 very much worse.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Body Weight</measure>
    <time_frame>baseline and 17 weeks (or last observation carried forward)</time_frame>
    <description>changes in body weight</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Binge-Eating Disorder</condition>
  <arm_group>
    <arm_group_label>Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg via subcutaneous injection. Matching the recommended dosage and administration guidelines of the FDA-approved labeling for the use of liraglutide (Saxenda), the medication will be initiated at 0.6 mg daily for 1 week, and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day is achieved. Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg of placebo via subcutaneous injection. The placebo will be initiated at 0.6 mg daily for 1 week, and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day is achieved.The inactive ingredients include: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml</intervention_name>
    <description>subcutaneous injection, pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg (6 mg/mL, 3 mL). Matching the recommended dosage and administration guidelines of the FDA-approved labeling for the use of liraglutide (Saxenda), the medication will be initiated at 0.6 mg daily for 1 week, and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day is achieved.</description>
    <arm_group_label>Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>subcutaneous injection, pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg (6 mg/mL, 3 mL). It is designed to be identical to the pen used for liraglutide (Saxenda). Placebo product inactive ingredients: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. BMI &gt; 30 kg/m2 or BMI ≥ 27 - 29.9 kg/m² in the presence of at least one weight-related&#xD;
             comorbid condition, such as binge eating disorder, hypertension, or dyslipidemia.&#xD;
             There is no upper BMI limit for this trial.&#xD;
&#xD;
          2. Age ≥ 21 years and ≤ 70 years&#xD;
&#xD;
          3. Meet full DSM 5 criteria for BED&#xD;
&#xD;
               1. Recurrent episodes of binge eating characterized by both consuming an abnormally&#xD;
                  large amount of food in a short period of time compared with what others might&#xD;
                  eat in the same amount of time under the same or similar circumstances and&#xD;
                  experiencing a loss of control over eating during the episode.&#xD;
&#xD;
               2. These episodes feature at least 3 of the following:&#xD;
&#xD;
             i. consuming food more rapidly than normal; ii. eating until uncomfortably full; iii.&#xD;
             consuming large amounts of food when not hungry; iv. consuming food alone due to&#xD;
             embarrassment; v. feeling disgusted, depressed, or guilty after eating a large amount&#xD;
             of food. c. Significant distress about the binge episodes is present. d. Binge&#xD;
             episodes must occur, on average, at least once per week for 3 months.&#xD;
&#xD;
          4. All races and ethnicities are included&#xD;
&#xD;
          5. Eligible female subjects will be:&#xD;
&#xD;
               -  non-pregnant, evidenced by a negative urine dipstick pregnancy test&#xD;
&#xD;
               -  non-lactating&#xD;
&#xD;
               -  surgically sterile or postmenopausal, or they will agree to continue to use an&#xD;
                  accepted method of birth control during the study&#xD;
&#xD;
          6. Ability to provide informed consent before any trial-related activities&#xD;
&#xD;
          7. Subjects must:&#xD;
&#xD;
               -  have a primary care provider (PCP) who is responsible for providing routine care&#xD;
&#xD;
               -  have reliable telephone or Internet service to communicate with study staff&#xD;
&#xD;
               -  understand and be willing to comply with all study-related procedures and agree&#xD;
                  to participate in the study by giving written informed consent&#xD;
&#xD;
               -  plan to remain in the Philadelphia area for the next 6 months or more&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant or nursing, or plans to become pregnant in the next 6 months, or not using&#xD;
             adequate contraceptive measures&#xD;
&#xD;
          2. Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia&#xD;
             syndrome type 2&#xD;
&#xD;
          3. Uncontrolled hypertension (systolic blood pressure ≥ 160 mm Hg or diastolic blood&#xD;
             pressure ≥ 100 mm Hg)&#xD;
&#xD;
          4. Type 1 diabetes&#xD;
&#xD;
          5. Type 2 diabetes&#xD;
&#xD;
          6. A combination of fasting glucose ≥ 126 mg/dl, combined with an HbA1c &gt;6.5, will be&#xD;
             used to indicate the presence of diabetes, an exclusion criterion&#xD;
&#xD;
          7. Recent history of cardiovascular disease (e.g., myocardial infarction or stroke within&#xD;
             the past 6 months), congestive heart failure, or heart block greater than first degree&#xD;
&#xD;
          8. Clinically significant hepatic or renal disease&#xD;
&#xD;
          9. Thyroid disease, not controlled&#xD;
&#xD;
         10. History of malignancy (except for non-melanoma skin cancer) in past 5 years&#xD;
&#xD;
         11. The presence of current anorexia nervosa or bulimia nervosa&#xD;
&#xD;
         12. Current major depressive episode, active suicidal ideation, or lifetime history of&#xD;
             suicide attempts. We will exclude participants who have a Patient Health&#xD;
             Questionnaire-9 (PHQ-9) [31] score &gt; 15, or a score of &gt; 1 on the suicidal ideation&#xD;
             item, as well as any risk of suicidality as measured by a score of 4 or 5 on the&#xD;
             Columbia-Suicide Severity Rating Scale (C-SSRS)[32].&#xD;
&#xD;
         13. Psychiatric hospitalization within the past 6 months&#xD;
&#xD;
         14. Self-reported alcohol or substance abuse within the past 12 months, including at-risk&#xD;
             drinking (current consumption of ≥ 14 alcoholic drinks per week)&#xD;
&#xD;
         15. Diagnosis current or past psychosis&#xD;
&#xD;
         16. Use in past 3 months of medications known to treat BED (such as lisdexamfetamine),&#xD;
             induce significant weight loss (i.e., prescription weight loss medications), or induce&#xD;
             weight gain (e.g., chronic use of oral steroids, second generation antipsychotics)&#xD;
&#xD;
         17. Currently receiving behavioral or pharmacological treatment for BED&#xD;
&#xD;
         18. Loss of ≥ 10 lb of body weight within the past 3 months&#xD;
&#xD;
         19. Known or suspected allergy to trial medication(s), excipients, or related products&#xD;
&#xD;
         20. Hypersensitivity to liraglutide or any product components&#xD;
&#xD;
         21. The receipt of any investigational drug within 6 months prior to this trial&#xD;
&#xD;
         22. Previous participation in this trial (e.g., randomized and failed to participate)&#xD;
&#xD;
         23. History of pancreatitis&#xD;
&#xD;
         24. History of gastrointestinal surgery (unless it was an adjustable gastric band that has&#xD;
             been removed).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kelly C Allison, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pennsylvania</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Pennyslvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19140</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <results_first_submitted>September 30, 2020</results_first_submitted>
  <results_first_submitted_qc>November 2, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">November 24, 2020</results_first_posted>
  <last_update_submitted>November 2, 2020</last_update_submitted>
  <last_update_submitted_qc>November 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Pennsylvania</investigator_affiliation>
    <investigator_full_name>Kelly Allison</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>eating disorder, pharmacotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bulimia</mesh_term>
    <mesh_term>Feeding and Eating Disorders</mesh_term>
    <mesh_term>Binge-Eating Disorder</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liraglutide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is no plan to make individual participant data available to other researchers.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 20, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/31/NCT03279731/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 9, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/31/NCT03279731/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were recruited at university based medical school clinic setting. The first participant was randomized on September 29, 2017; the last participant completed participation on September 6, 2019.&#xD;
Note: 9 participants were censored from the trial due to an error in medication/placebo assignment by the Investigational Drug Service. As such, these 9 participants were not considered in any of the analyses presented, leaving 13 in the liraglutide and 14 in the placebo group.</recruitment_details>
      <pre_assignment_details>Participants underwent a 2 week run in to assure that they continued to have binge episodes before being randomized to placebo or liraglutide 3.0 mg.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml</title>
          <description>Pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg via subcutaneous injection. Matching the recommended dosage and administration guidelines of the FDA-approved labeling for the use of liraglutide (Saxenda), the medication will be initiated at 0.6 mg daily for 1 week, and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day is achieved. Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist.&#xD;
Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml: subcutaneous injection, pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg (6 mg/mL, 3 mL). Matching the recommended dosage and administration guidelines of the FDA-approved labeling for the use of liraglutide (Saxenda), the medication will be initiated at 0.6 mg daily for 1 week, and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day is achieved.</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg of placebo via subcutaneous injection. The placebo will be initiated at 0.6 mg daily for 1 week, and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day is achieved.The inactive ingredients include: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection.&#xD;
Placebo: subcutaneous injection, pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg (6 mg/mL, 3 mL). It is designed to be identical to the pen used for liraglutide (Saxenda). Placebo product inactive ingredients: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml</title>
          <description>Pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg via subcutaneous injection. Matching the recommended dosage and administration guidelines of the FDA-approved labeling for the use of liraglutide (Saxenda), the medication will be initiated at 0.6 mg daily for 1 week, and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day is achieved. Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist.&#xD;
Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml: subcutaneous injection, pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg (6 mg/mL, 3 mL). Matching the recommended dosage and administration guidelines of the FDA-approved labeling for the use of liraglutide (Saxenda), the medication will be initiated at 0.6 mg daily for 1 week, and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day is achieved.</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg of placebo via subcutaneous injection. The placebo will be initiated at 0.6 mg daily for 1 week, and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day is achieved.The inactive ingredients include: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection.&#xD;
Placebo: subcutaneous injection, pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg (6 mg/mL, 3 mL). It is designed to be identical to the pen used for liraglutide (Saxenda). Placebo product inactive ingredients: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection</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="13"/>
            <count group_id="B2" value="14"/>
            <count group_id="B3" value="27"/>
          </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="46.4" spread="7.9"/>
                    <measurement group_id="B2" value="42.1" spread="12.7"/>
                    <measurement group_id="B3" value="44.2" spread="10.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Male at birth</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Female at birth</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>objective binge episodes per week</title>
          <units>binge episodes/week</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.90" spread="0.69"/>
                    <measurement group_id="B2" value="2.80" spread="0.67"/>
                    <measurement group_id="B3" value="3.30" spread="2.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Binge Episodes</title>
        <description>Change in objective binge episodes per week from randomization (week 0) to study end (week 17)</description>
        <time_frame>baseline and 17 weeks (or last observation carried forward)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Liraglutide</title>
            <description>Participants randomized to liraglutide 3.0 mg/d</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants randomized to placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Binge Episodes</title>
          <description>Change in objective binge episodes per week from randomization (week 0) to study end (week 17)</description>
          <units>objective binge episodes per week</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.97" spread="0.56"/>
                    <measurement group_id="O2" value="-2.50" spread=".053"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Remission From Binge-eating</title>
        <description>the percentage of participants (completers) who have achieved remission from binge-eating (no binge episodes between weeks 13 - 17)</description>
        <time_frame>13 to 17 weeks</time_frame>
        <population>Remission was calculated for completers who had data from weeks 13-17</population>
        <group_list>
          <group group_id="O1">
            <title>Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml</title>
            <description>Pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg via subcutaneous injection. Matching the recommended dosage and administration guidelines of the FDA-approved labeling for the use of liraglutide (Saxenda), the medication will be initiated at 0.6 mg daily for 1 week, and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day is achieved. Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist.&#xD;
Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml: subcutaneous injection, pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg (6 mg/mL, 3 mL). Matching the recommended dosage and administration guidelines of the FDA-approved labeling for the use of liraglutide (Saxenda), the medication will be initiated at 0.6 mg daily for 1 week, and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day is achieved.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg of placebo via subcutaneous injection. The placebo will be initiated at 0.6 mg daily for 1 week, and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day is achieved.The inactive ingredients include: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection.&#xD;
Placebo: subcutaneous injection, pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg (6 mg/mL, 3 mL). It is designed to be identical to the pen used for liraglutide (Saxenda). Placebo product inactive ingredients: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection</description>
          </group>
        </group_list>
        <measure>
          <title>Remission From Binge-eating</title>
          <description>the percentage of participants (completers) who have achieved remission from binge-eating (no binge episodes between weeks 13 - 17)</description>
          <population>Remission was calculated for completers who had data from weeks 13-17</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="7"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Assessment of Improvement of Binge Eating Symptoms</title>
        <description>week 17 rating on the interviewer-based Clinical Global Impression of Improvement (CGII) Scale for global assessment of BED symptoms The CGII includes the following rating scale: Compared to the patient's condition at baseline to the project [prior to medication initiation], this patient's condition is: 1 very much improved; 2 much improved; 3 improved; 4 no change; 5 worse; 6 much worse; 7 very much worse.</description>
        <time_frame>week 17 (or last observation carried forward)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml</title>
            <description>Pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg via subcutaneous injection. Matching the recommended dosage and administration guidelines of the FDA-approved labeling for the use of liraglutide (Saxenda), the medication will be initiated at 0.6 mg daily for 1 week, and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day is achieved. Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist.&#xD;
Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml: subcutaneous injection, pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg (6 mg/mL, 3 mL). Matching the recommended dosage and administration guidelines of the FDA-approved labeling for the use of liraglutide (Saxenda), the medication will be initiated at 0.6 mg daily for 1 week, and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day is achieved.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg of placebo via subcutaneous injection. The placebo will be initiated at 0.6 mg daily for 1 week, and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day is achieved.The inactive ingredients include: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection.&#xD;
Placebo: subcutaneous injection, pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg (6 mg/mL, 3 mL). It is designed to be identical to the pen used for liraglutide (Saxenda). Placebo product inactive ingredients: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection</description>
          </group>
        </group_list>
        <measure>
          <title>Assessment of Improvement of Binge Eating Symptoms</title>
          <description>week 17 rating on the interviewer-based Clinical Global Impression of Improvement (CGII) Scale for global assessment of BED symptoms The CGII includes the following rating scale: Compared to the patient's condition at baseline to the project [prior to medication initiation], this patient's condition is: 1 very much improved; 2 much improved; 3 improved; 4 no change; 5 worse; 6 much worse; 7 very much worse.</description>
          <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="13"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.52" spread=".27"/>
                    <measurement group_id="O2" value="1.93" spread=".26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Body Weight</title>
        <description>changes in body weight</description>
        <time_frame>baseline and 17 weeks (or last observation carried forward)</time_frame>
        <population>Last Observation Carried Forward</population>
        <group_list>
          <group group_id="O1">
            <title>Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml</title>
            <description>Pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg via subcutaneous injection. Matching the recommended dosage and administration guidelines of the FDA-approved labeling for the use of liraglutide (Saxenda), the medication will be initiated at 0.6 mg daily for 1 week, and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day is achieved. Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist.&#xD;
Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml: subcutaneous injection, pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg (6 mg/mL, 3 mL). Matching the recommended dosage and administration guidelines of the FDA-approved labeling for the use of liraglutide (Saxenda), the medication will be initiated at 0.6 mg daily for 1 week, and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day is achieved.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg of placebo via subcutaneous injection. The placebo will be initiated at 0.6 mg daily for 1 week, and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day is achieved.The inactive ingredients include: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection.&#xD;
Placebo: subcutaneous injection, pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg (6 mg/mL, 3 mL). It is designed to be identical to the pen used for liraglutide (Saxenda). Placebo product inactive ingredients: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Body Weight</title>
          <description>changes in body weight</description>
          <population>Last Observation Carried Forward</population>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.7" spread="0.83"/>
                    <measurement group_id="O2" value="-0.94" spread="0.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>from the beginning to the end of the 17 week trial</time_frame>
      <desc>Adverse event data collection occurred at each study visit.</desc>
      <group_list>
        <group group_id="E1">
          <title>Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml</title>
          <description>Pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg via subcutaneous injection. Matching the recommended dosage and administration guidelines of the FDA-approved labeling for the use of liraglutide (Saxenda), the medication will be initiated at 0.6 mg daily for 1 week, and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day is achieved. Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist.&#xD;
Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml: subcutaneous injection, pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg (6 mg/mL, 3 mL). Matching the recommended dosage and administration guidelines of the FDA-approved labeling for the use of liraglutide (Saxenda), the medication will be initiated at 0.6 mg daily for 1 week, and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day is achieved.</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg of placebo via subcutaneous injection. The placebo will be initiated at 0.6 mg daily for 1 week, and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day is achieved.The inactive ingredients include: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection.&#xD;
Placebo: subcutaneous injection, pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg (6 mg/mL, 3 mL). It is designed to be identical to the pen used for liraglutide (Saxenda). Placebo product inactive ingredients: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalization due to vomiting</sub_title>
                <description>Participant notified study staff that he was hospitalized for vomiting . Patient did not want to continue the phone conversation and no other information has been gathered.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Ulcerative colitis flare</sub_title>
                <description>Hospitalized from 1/3/18-1/5/18. Treated with Remicade infusion. Reported feeling back to baseline on 1/7/18.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>laparoscopic cholecystectomy</sub_title>
                <description>abdominal pain, nausea and cholecystectomy</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <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="17" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>tachycardua</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>bilateral otitis media</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>sty</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>nausea</sub_title>
                <counts group_id="E1" events="7" subjects_affected="5" subjects_at_risk="19"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>diarrhea</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>indigestion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>gastroenteritis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>cholitis flare</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>dry mouth</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>allergic rhinitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>toothache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>worsening edema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>upper respiratory infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>strep throat</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>flu</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>common cold</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>joint pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>vaginal bleeding</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>suicidal ideation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>depressive symptoms</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>insomnia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>UTI</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </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>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Error by Investigational Drug Service - randomization key interpreted incorrectly at n=21 n= 6 had 2+ consecutive boxes of same agent and were retained in analyses (data censored after first switch); 6 received same agent consistently; n=9 censored</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Kelly C. Allison, PhD</name_or_title>
      <organization>Perelman School of Medicine at the University of Pennsylvania</organization>
      <phone>2158982823</phone>
      <email>kca@pennmedicine.upenn.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03279731
org study id: 827450
nct id: NCT03279731
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The study is a 17-week, single-center, double-blind, parallel-group, randomized placebo
      controlled trial that will test the efficacy of liraglutide 3.0 mg/d as compared to placebo
      in reducing the number of binge episodes per week, achieving remission from binge episodes,
      and in changes in body weight, global BED symptom improvement, cognitive restraint of food
      intake, dietary disinhibition, perceived hunger, quality of life, and depressed mood at
      treatment end.
All applicants will be initially screened by phone and/or electronically to determine whether
      they potentially meet eligibility criteria. Those who appear to meet eligibility criteria and
      remain interested in the trial will be scheduled for an in-person interview.

      The in-person interview will be conducted by a psychologist or Masters' level staff member,
      who will obtain informed consent and evaluate subjects' behavioral eligibility (i.e.,
      willingness and appropriateness to participate) using structured and semi-structured clinical
      interviews including: an examination of the applicants' BED symptoms, their mood,
      suicidality, and other general psychopathology. Participants will also be asked to complete
      questionnaires assessing eating behavior, demographic characteristics, frequency of specific
      eating behaviors related to loss of control, risk of substance dependence with the
      consumption of high fat/sugar foods, alexithymia, night eating syndrome, sleep patterns and
      quality, and attitudes towards food cravings.

      Subjects who remain interested and pass this portion of the assessment will proceed to meet
      with the study physician or nurse practitioner, who will obtain a medical history and conduct
      a physical examination to determine medical eligibility. Subjects will also have an
      electrocardiogram (EKG), fasting blood test, and a urine pregnancy test (for females of child
      bearing age) to confirm eligibility.

      Upon successful completion of the screening visit, subjects will be asked to eat as they
      normally would for 2 weeks. Once per week over these two weeks they will receive a brief
      survey through REDcap to assess their binge eating episodes for eligibility.

      Subjects who continue to meet eligibility criteria assessed at the screening visit and during
      the run-in period will be scheduled for a randomization visit at the Center within 3 weeks of
      their screening.

      Subjects will be randomly assigned to the two interventions in equal numbers (i.e., 1:1
      ratio). The subject's weight, blood pressure, and pulse will then be measured. Following
      randomization, all subjects will have a medical visit with the study physician or nurse
      practitioner who will instruct them in the use of liraglutide 3.0 (as described later) and
      provide the first month's supply of medication.

      After randomization, subjects will return at week 1 to assess rate of response. Subjects will
      return for study visits every two weeks thereafter, at weeks 3, 5, 7, 9, 11, 13, 15, and 17.

      These study visits include a brief medical visit (10-15 minutes) with a physician or nurse
      practitioner to monitor their response to the medication or any changes in health. Vitals and
      weight will be taken. Additionally, binge episodes, mood, suicidality, and symptom
      improvement will be assessed by the psychologist or Masters' level trained study staff.
      Participants will be asked also to complete questionnaires assessing quality of life,
      obsessions related to food, and food cravings prior to each treatment visit for the secondary
      outcomes:

      In summary, study visits will consist of the medical visit, completion of written surveys,
      review of structured interviews with the study staff and review of medication adverse events.
      These visits are expected to last about 30-40 minutes. The study assessments at week 17 will
      consist of the previously listed procedures and measures in addition to the questionnaires
      and blood tests conducted at baseline.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Single-center, double-blind, randomized placebo-controlled trial with parallel groups.
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Novo Nordisk's Clinical Services (CS) will label, package, and ship the labelled study drugs to the Penn's Investigational Drug Service (IDS). Dr. Rockwell from Penn's IDS service will generate the randomization code using a 1:1 randomization scheme of liraglutide and placebo. The first subject to meet the treatment criteria will be assigned the first number in the sequence; each subsequent subject to meet treatment criteria will be assigned the next number in the sequence. Unblinding of the treatment codes will occur after all data have been verified and deemed clean by the data managers and statistician, and right before analysis of the data occurs.
The code for a particular subject may be broken in a medical emergency if knowing the identity of the treatment allocation would influence the treatment of the subject or if demanded by the subject. Whenever a code is broken, the staff-member breaking the code will record the time, date and reason.
measure: Binge Episodes
time frame: baseline and 17 weeks (or last observation carried forward)
description: Change in objective binge episodes per week from randomization (week 0) to study end (week 17)
measure: Remission From Binge-eating
time frame: 13 to 17 weeks
description: the percentage of participants (completers) who have achieved remission from binge-eating (no binge episodes between weeks 13 - 17)
measure: Assessment of Improvement of Binge Eating Symptoms
time frame: week 17 (or last observation carried forward)
description: week 17 rating on the interviewer-based Clinical Global Impression of Improvement (CGII) Scale for global assessment of BED symptoms The CGII includes the following rating scale: Compared to the patient's condition at baseline to the project [prior to medication initiation], this patient's condition is: 1 very much improved; 2 much improved; 3 improved; 4 no change; 5 worse; 6 much worse; 7 very much worse.
measure: Change in Body Weight
time frame: baseline and 17 weeks (or last observation carried forward)
description: changes in body weight
arm group label: Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml
arm group type: Active Comparator
description: Pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg via subcutaneous injection. Matching the recommended dosage and administration guidelines of the FDA-approved labeling for the use of liraglutide (Saxenda), the medication will be initiated at 0.6 mg daily for 1 week, and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day is achieved. Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist.
arm group label: Placebo
arm group type: Placebo Comparator
description: Pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg of placebo via subcutaneous injection. The placebo will be initiated at 0.6 mg daily for 1 week, and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day is achieved.The inactive ingredients include: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection.
intervention type: Drug
intervention name: Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml
description: subcutaneous injection, pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg (6 mg/mL, 3 mL). Matching the recommended dosage and administration guidelines of the FDA-approved labeling for the use of liraglutide (Saxenda), the medication will be initiated at 0.6 mg daily for 1 week, and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day is achieved.
arm group label: Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml
intervention type: Drug
intervention name: Placebo
description: subcutaneous injection, pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg (6 mg/mL, 3 mL). It is designed to be identical to the pen used for liraglutide (Saxenda). Placebo product inactive ingredients: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection
arm group label: Placebo
criteria: 
gender: All
minimum age: 21 Years
maximum age: 70 Years
healthy volunteers: No
last name: Kelly C Allison, PhD
role: Principal Investigator
affiliation: University of Pennsylvania
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Pennsylvania
investigator full name: Kelly Allison
investigator title: Associate Professor
mesh term: Bulimia
mesh term: Feeding and Eating Disorders
mesh term: Binge-Eating Disorder
mesh term: Liraglutide
sharing ipd: No
ipd description: There is no plan to make individual participant data available to other researchers.
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Error by Investigational Drug Service - randomization key interpreted incorrectly at n=21 n= 6 had 2+ consecutive boxes of same agent and were retained in analyses (data censored after first switch); 6 received same agent consistently; n=9 censored
point of contact: 