Oxytocin for Weight Loss in Adolescents
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Obesity, Adolescent, Oxytocin
In brief
This is a randomized, double blind, placebo-controlled study of the effects of intranasal oxytocin in youths with obesity, ages 10-18 years old. Subjects will be randomized to receive intranasal oxytocin or placebo (1 spray 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.
Key facts
- Study ID
- NCT04551482
- Run by
- Massachusetts General Hospital
- People needed
- 55
- Starts
- 2021-07-28
- Expected to finish
- 2027-02-28
- Last updated by the study team
- 2026-06-26
Who can join
Age: 10 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Males and Females, 10-18 years
- Obesity (BMI ≥95th percentile for age and gender)
- Willingness to maintain current diet and lifestyle for the duration of study participation
You may not qualify if…
- Current substance abuse
- Use of prescription or over-the-counter drugs or dietary/herbal supplements that may affect weight if dose increased in the three months preceding the baseline visit and/or if they plan to increase the dose during the 18 weeks of study participation.
- Greater than 5kg weight loss over 3 months;
- Follows a nonstandard diet (e.g., Paleo, Atkins, raw diet, macrobiotic diet)
- Cardiovascular disease
- Prolonged QT interval
- Chronic inflammatory bowel disease and other inflammatory conditions
- Epilepsy
- TSH > 2.5 times upper limit of normal
- 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
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
Full record on ClinicalTrials.gov
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