Tests oxytocin nasal spray for weight loss in teens with obesity
Tests an oxytocin nasal spray against a placebo in youths with obesity.
Plain-language title generated from the registry record
Registry title: Oxytocin for Weight Loss in Adolescents
Key facts
- Where
- Boston, United StatesSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 10 and 18 years old?
Source: NCT04551482, who can take part
Where in United States
- Massachusetts General HospitalBoston, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Massachusetts General Hospital
- Trial code
- NCT04551482
- Record updated
- 4 November 2026
- Original description
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.Read full original descriptionShow less
Oxytocin as a Neuroendocrine Therapy for Obesity in Youth
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.
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: 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; Cardiovascular disease; Chronic inflammatory bowel disease and other inflammatory conditions; Epilepsy; Active eating disorder; Prolonged QT interval; Alanine transaminase (ALT) or aspartate transaminase (AST) >2.5 times upper limit of normal; Creatinine >1.5 mg/dl; Type 1 Diabetes Mellitus or Type 2 Diabetes Mellitus if HbA1c >8%; Current substance abuse; Greater than 5kg weight loss over 3 months; Follows a nonstandard diet (e.g., Paleo, Atkins, raw diet, macrobiotic diet); TSH > 2.5 times upper limit of normal; 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.