Oxytocin for Weight Loss in Adolescents

This study is looking into whether oxytocin nasal spray can help adolescents (young people aged 10-18) with obesity lose weight. Researchers want to see if oxytocin, a natural hormone, can help by possibly reducing how much food is eaten and increasing how many calories are burned. You could be eligible if you are between 10 and 18 years old, have obesity (a body mass index, or BMI, at or above the 95th percentile for your age and gender), and are willing to keep your current diet and lifestyle during the study. The main goal is to see if there's a change in your BMI after 12 weeks. The current status of this study is unclear.

Study design
This is a randomized, double-blind, placebo-controlled study, meaning participants will be randomly assigned to receive either oxytocin nasal spray or a placebo (an inactive spray), and neither you nor the researchers will know which you are receiving. About 55 participants are planned for this study.
What's involved
You would use a nasal spray four times a day for 12 weeks. This study involves screening, main study visits at baseline, week 8, and week 12, safety check-in visits at weeks 1 and 4, and phone calls at weeks 2, 6, and 10.
Compensation
Not stated in the trial record.
Follow-up
There will be a safety follow-up visit 6 weeks after your last dose of the study drug.

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NCT04551482

Oxytocin for Weight Loss in Adolescents

Recruiting
PHASE2Ages 10–18InterventionalTreatment
Massachusetts General Hospital
~55 participants
Updated 2026-06-26 on ClinicalTrials.gov
What's tested:Oxytocin nasal sprayPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Body mass index (BMI)
Measured over 12 weeks
Obesity, Adolescent
Oxytocin
1 sites across 1 states
Massachusetts1
  • Elizabeth Lawson, MD, MMSc · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

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Eligibility criteria

Inclusion

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

Exclusion

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
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
  • Body mass index (BMI)12 weeks

    Mean difference in BMI between Oxytocin and Placebo group after 12 weeks of treatment. BMI will be calculated as weight/height2