Using oxytocin nasal spray to help adolescents lose weight
Oxytocin as a Neuroendocrine Therapy for Obesity in Youth
PHASE2 · Massachusetts General Hospital · NCT04551482
This study is testing if a nasal spray with oxytocin can help teenagers aged 12-18 who are struggling with obesity to lose weight by reducing their appetite and boosting their metabolism.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 10 Years to 18 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital (other) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04551482 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 12-18 years with obesity defined as a BMI at or above the 95th percentile for their age and gender.
Not a fit: Patients with active substance abuse, certain chronic health conditions, or those on specific weight-loss medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel and effective weight loss option for adolescents struggling with obesity.
How similar studies have performed: While oxytocin has shown promise in adult obesity treatments, this specific application in adolescents is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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: * Active substance abuse * Use of prescription or over-the-counter drugs or dietary/herbal supplements for the purpose of weight loss. Medications/supplements that may affect weight will be allowed if participants are on a stable dose with stable weight for at least 3 months. * Greater than 5kg weight loss over 3 months; * Follows a nonstandard diet (e.g., gluten-free, vegan, Paleo, Atkins, raw diet, macrobiotic diet) * Cardiovascular disease * Prolonged QT interval * Chronic gastrointestinal disorders and other inflammatory conditions * Epilepsy * Untreated thyroid disease * 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 this trial is running
Boston, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obesity, Adolescent, Oxytocin