Oxytocin for Weight Loss in Adolescents

• Status: Recruiting
• Trial end date: 2025-09-30
• Target enrollment: 0
• Participant gender: All

Summary

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, 2, 4, and 6, with a safety follow-up visit 6 weeks after the last dose of study drug. Study procedures include appetite, behavioral, metabolic, and endocrine assessments.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: National Institutes of Health (NIH)
• Treatments: Oxytocin

Criteria

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 affecting metabolism, blood glucose, or appetite. Metformin will be allowed if participants are on a stable dose with stable weight for at least 3 months

• Greater than 5kg weight change 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

• ALT or 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

• Use of oral contraceptive pills

• 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 and type 2 Diabetes Mellitus if HbA1c >8%