Using oxytocin nasal spray to help adolescents lose weight

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of intranasal oxytocin on weight loss in adolescents aged 12-18 years with obesity. Participants will be randomly assigned to receive either oxytocin or a placebo for 12 weeks, with assessments of appetite, behavior, metabolism, and endocrine function. The study aims to determine if oxytocin can reduce caloric intake and increase energy expenditure, potentially improving metabolic health markers. Regular safety check-ins and follow-ups will ensure participant well-being throughout the trial.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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's running

• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Elizabeth Lawson, MD, MMSc — Massachusetts General Hospital
• Study coordinator: Elizabeth A Lawson, MD, MMSc
• Email: ealawson@partners.org
• Phone: 617-726-3870

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.