<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/NCT03043053</url>
  </required_header>
  <id_info>
    <org_study_id>2016P002810</org_study_id>
    <nct_id>NCT03043053</nct_id>
  </id_info>
  <brief_title>The Effects of Oxytocin in Obese Adults</brief_title>
  <official_title>A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of Repeat Doses of Intranasal Oxytocin in Obese Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</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>
      This is a randomized, double blind, placebo-controlled study of the effects of intranasal&#xD;
      oxytocin in obese adults, ages 18-45 years old. Subjects will be randomized to receive of&#xD;
      intranasal oxytocin or placebo (3 sprays per nostril, 4 times per day) for 8 weeks. Study&#xD;
      visits include screening to determine eligibility, a 2-part baseline visit, and visits every&#xD;
      2 weeks thereafter until week 14, with a safety follow-up visit 6 weeks after the last dose&#xD;
      of study drug. Study procedures include behavioral, metabolic, neuroimaging, and endocrine&#xD;
      assessments.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Actual">July 7, 2022</completion_date>
  <primary_completion_date type="Actual">May 20, 2022</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean difference in weight loss between Oxytocin and placebo 8 weeks after Baseline</measure>
    <time_frame>Baseline to 8 weeks</time_frame>
    <description>The difference between the mean weight loss values between Oxytocin and placebo-treated groups at 8 weeks after Baseline</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in resting energy expenditure after 8 weeks of Oxytocin versus placebo</measure>
    <time_frame>Baseline to 8 weeks</time_frame>
    <description>Change in resting energy expenditure from Baseline to 8 weeks in the oxytocin versus placebo-treated groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fat depots after 8 weeks of Oxytocin versus placebo</measure>
    <time_frame>Baseline to 8 weeks</time_frame>
    <description>Change in fat depots from baseline to 8 weeks in the Oxytocin versus placebo-treated groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in caloric intake after 6 weeks of Oxytocin versus placebo</measure>
    <time_frame>Baseline to 6 weeks</time_frame>
    <description>Difference in caloric intake after 6 weeks of Oxytocin versus placebo treatment</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>oxytocin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>oxytocin nasal spray (24 IU nasal spray, 4 times per day for 8 weeks)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>placebo nasal spray (4 times per day for 8 weeks)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>oxytocin nasal spray</intervention_name>
    <description>oxytocin intranasal spray</description>
    <arm_group_label>oxytocin</arm_group_label>
    <other_name>Syntocinon</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo nasal spray</description>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-45 years old;&#xD;
&#xD;
          -  BMI greater than or equal to 30 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of drug affecting metabolism, glucose, or appetite (Metformin is allowed if dose&#xD;
             and weight are stable for at least 3 months);&#xD;
&#xD;
          -  history of medication changes within 4 weeks of enrollment;&#xD;
&#xD;
          -  active substance use;&#xD;
&#xD;
          -  history of cardiovascular disease, gastrointestinal disorders, bariatric surgery,&#xD;
             epilepsy, untreated thyroid disease;&#xD;
&#xD;
          -  hematocrit &gt;2% below normal;&#xD;
&#xD;
          -  fasting glucose &gt; 125 mg/dL or hemoglobin A1c ≥ 7% ;&#xD;
&#xD;
          -  ALT or AST &gt;2.5 times upper limit of normal;&#xD;
&#xD;
          -  Cr &gt;1.5 mg/dL; hyponatremia;&#xD;
&#xD;
          -  pregnancy or breastfeeding;&#xD;
&#xD;
          -  unwilling to use medically acceptable form of contraception (females only)&#xD;
&#xD;
          -  follows a nonstandard diet (e.g., gluten free, pescatarian, vegetarian, vegan, Paleo,&#xD;
             Atkins, raw diet, macrobiotic diet)&#xD;
&#xD;
          -  current smoking or tobacco use&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elizabeth A Lawson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>February 1, 2017</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <disposition_first_submitted>May 11, 2023</disposition_first_submitted>
  <disposition_first_submitted_qc>May 11, 2023</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">June 6, 2023</disposition_first_posted>
  <last_update_submitted>July 19, 2023</last_update_submitted>
  <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Elizabeth Austen Lawson</investigator_full_name>
    <investigator_title>Associate Professor of Medicine, Harvard Medical School</investigator_title>
  </responsible_party>
  <keyword>weight loss</keyword>
  <keyword>body mass index</keyword>
  <keyword>oxytocin</keyword>
  <keyword>magnetic resonance imaging</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oxytocin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>August 22, 2023</submitted>
    <returned>September 15, 2023</returned>
  </pending_results>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT03043053
org study id: 2016P002810
nct id: NCT03043053
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a randomized, double blind, placebo-controlled study of the effects of intranasal
      oxytocin in obese adults, ages 18-45 years old. Subjects will be randomized to receive of
      intranasal oxytocin or placebo (3 sprays per nostril, 4 times per day) for 8 weeks. Study
      visits include screening to determine eligibility, a 2-part baseline visit, and visits every
      2 weeks thereafter until week 14, with a safety follow-up visit 6 weeks after the last dose
      of study drug. Study procedures include behavioral, metabolic, neuroimaging, and endocrine
      assessments.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Mean difference in weight loss between Oxytocin and placebo 8 weeks after Baseline
time frame: Baseline to 8 weeks
description: The difference between the mean weight loss values between Oxytocin and placebo-treated groups at 8 weeks after Baseline
measure: Change in resting energy expenditure after 8 weeks of Oxytocin versus placebo
time frame: Baseline to 8 weeks
description: Change in resting energy expenditure from Baseline to 8 weeks in the oxytocin versus placebo-treated groups
measure: Change in fat depots after 8 weeks of Oxytocin versus placebo
time frame: Baseline to 8 weeks
description: Change in fat depots from baseline to 8 weeks in the Oxytocin versus placebo-treated groups
measure: Difference in caloric intake after 6 weeks of Oxytocin versus placebo
time frame: Baseline to 6 weeks
description: Difference in caloric intake after 6 weeks of Oxytocin versus placebo treatment
arm group label: oxytocin
arm group type: Experimental
description: oxytocin nasal spray (24 IU nasal spray, 4 times per day for 8 weeks)
arm group label: placebo
arm group type: Placebo Comparator
description: placebo nasal spray (4 times per day for 8 weeks)
intervention type: Drug
intervention name: oxytocin nasal spray
description: oxytocin intranasal spray
arm group label: oxytocin
other name: Syntocinon
intervention type: Drug
intervention name: Placebo
description: Placebo nasal spray
arm group label: placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Elizabeth A Lawson, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Elizabeth Austen Lawson
investigator title: Associate Professor of Medicine, Harvard Medical School
mesh term: Oxytocin
sharing ipd: No
submitted: August 22, 2023
returned: September 15, 2023