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Oxytocin for Weight Loss in Adolescents
This is a randomized, double blind, placebo-controlled study of the effects of intranasal oxytocin in youths with obesity, ages 12-18 years old. Subjects will be randomized to receive intranasal oxytocin or placebo (3 sprays per nostril, 4 times per day) for 12 weeks. Study visits include screening to determine eligibility, 2-part main study visits at baseline, week 8, and week 12, and safety check-in visits at weeks 1, and 4; phone calls at weeks 2, 6, and 10, with a safety follow-up visit 6 weeks after the last dose of study drug. Study procedures include appetite, behavioral, metabolic, and endocrine assessments.
Conditions:
🦠 Obesity, Adolescent 🦠 Oxytocin
🗓️ Study Start (Actual) 28 July 2021
🗓️ Primary Completion (Estimated) 30 June 2026
✅ Study Completion (Estimated) 31 March 2027
👥 Enrollment (Estimated) 75
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Boston, Massachusetts, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Males and Females, 12-18 years
    • * Obesity (BMI ≥95th percentile for age and gender)
    • * Willingness to maintain current diet and lifestyle for the duration of study participation

    Exclusion Criteria:

    • * Active substance abuse
    • * Use of prescription or over-the-counter drugs or dietary/herbal supplements for the purpose of weight loss. Medications/supplements that may affect weight will be allowed if participants are on a stable dose with stable weight for at least 3 months.
    • * Greater than 5kg weight loss over 3 months;
    • * Follows a nonstandard diet (e.g., gluten-free, vegan, Paleo, Atkins, raw diet, macrobiotic diet)
    • * Cardiovascular disease
    • * Prolonged QT interval
    • * Chronic gastrointestinal disorders and other inflammatory conditions
    • * Epilepsy
    • * Untreated thyroid disease
    • * Alanine transaminase (ALT) or aspartate transaminase (AST) \>2.5 times upper limit of normal
    • * Creatinine \>1.5 mg/dl
    • * Hyponatremia
    • * Pregnancy/breastfeeding or refusal to use contraception not containing estrogen throughout the study if female and sexually active
    • * MRI exclusion criteria such as the presence of a pacemaker or cerebral aneurysm clips
    • * Weight \>450 lbs due to limits for MRI and DXA scanners
    • * Type 1 Diabetes Mellitus or Type 2 Diabetes Mellitus if HbA1c \>8%
    • * Active eating disorder
Ages Eligible for Study: 12 Years to 18 Years (CHILD, ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 31 August 2020
  • First Submitted that Met QC Criteria 10 September 2020
  • First Posted 16 September 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 14 May 2024
  • Last Update Posted 16 May 2024
  • Last Verified May 2024
I'm interested ...!!