Actively Recruiting
Oxytocin for Weight Loss in Adolescents
Led by Massachusetts General Hospital · Updated on 2025-07-20
75
Participants Needed
1
Research Sites
296 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 (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.
CONDITIONS
Official Title
Oxytocin for Weight Loss in Adolescents
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged 10 to 18 years
- Obesity defined as BMI at or above the 95th percentile for age and gender
- Willingness to maintain current diet and lifestyle during the study
You will not qualify if you...
- Active substance abuse
- Use of weight loss medications or supplements unless dose and weight have been stable for at least 3 months
- Weight loss greater than 5 kg within the past 3 months
- Following a nonstandard diet such as gluten-free, vegan, Paleo, Atkins, raw, or macrobiotic
- Cardiovascular disease or prolonged QT interval
- Chronic gastrointestinal or other inflammatory conditions
- Epilepsy
- Untreated thyroid disease
- Elevated liver enzymes (ALT or AST more than 2.5 times the upper limit)
- High creatinine levels (above 1.5 mg/dl)
- Low blood sodium (hyponatremia)
- Pregnancy, breastfeeding, or refusal to use estrogen-free contraception if female and sexually active
- MRI exclusion factors like pacemaker or cerebral aneurysm clips
- Weight over 450 lbs due to MRI and DXA limits
- Type 1 diabetes or type 2 diabetes with HbA1c over 8%
- Active eating disorder
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
E
Elizabeth A Lawson, MD, MMSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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