NCT04551482RecruitingPhase 2
Oxytocin for Weight Loss in Adolescents
Oxytocin as a Neuroendocrine Therapy for Obesity in Youth
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 54 (estimated)
- First submitted
- 31 Aug 2020
- Start date
- 28 Jul 2021
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Obesity
- NCT number
- NCT04551482
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 54
- From 28 Jul 2021 to the primary completion date, 31 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Cardiovascular disease
- Chronic inflammatory bowel disease and other inflammatory conditions
- Epilepsy
- Active eating disorder
Lab values
- 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%
Other
- 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
Who the study is looking for
- 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
Age in the registry: 10 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.