NCT04551482 Oxytocin for Weight Loss in Adolescents
| NCT ID | NCT04551482 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Massachusetts General Hospital |
| Condition | Obesity, Adolescent |
| Study Type | INTERVENTIONAL |
| Enrollment | 55 participants |
| Start Date | 2021-07-28 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 55 participants in total. It began in 2021-07-28 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Elizabeth Lawson, MD, MMSc
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT04551482 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 18 Years, studying Obesity, Adolescent. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04551482 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04551482 currently recruiting?
Yes, NCT04551482 is actively recruiting participants. Contact the research team at ealawson@partners.org for enrollment information.
Where is the NCT04551482 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT04551482 clinical trial?
NCT04551482 is sponsored by Massachusetts General Hospital. The principal investigator is Elizabeth Lawson, MD, MMSc at Massachusetts General Hospital. The trial plans to enroll 55 participants.
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