Phase 2
N=61
The Effects of Oxytocin in Obese Adults
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT03043053 ↗Enrolled (actual)
61
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Mean Difference in Weight Loss Between Oxytocin and Placebo 8 Weeks After Baseline — 0.20; 0.26 kilogram
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- oxytocin nasal spray (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Difference in Weight Loss Between Oxytocin and Placebo 8 Weeks After Baseline |
0.20; 0.26 | — |
| SECONDARY Change in Resting Energy Expenditure After 8 Weeks of Oxytocin Versus Placebo |
-17.8; 11.8 | — |
| SECONDARY Change in Fat Depots After 8 Weeks of Oxytocin Versus Placebo |
248.5; 52.5 | — |
| SECONDARY Difference in Caloric Intake After 6 Weeks of Oxytocin Versus Placebo |
-31.4; 120.6 | — |
Summary
This is a randomized, double blind, placebo-controlled study of the effects of intranasal oxytocin in obese adults, ages 18-45 years old. Subjects will be randomized to receive of intranasal oxytocin or placebo (3 sprays per nostril, 4 times per day) for 8 weeks. Study visits include screening to determine eligibility, a 2-part baseline visit, and visits every 2 weeks thereafter until week 14, with a safety follow-up visit 6 weeks after the last dose of study drug. Study procedures include behavioral, metabolic, neuroimaging, and endocrine assessments.
Eligibility Criteria
Inclusion Criteria
- 18-45 years old;
- BMI greater than or equal to 30 kg/m2
Exclusion Criteria
- Use of drug affecting metabolism, glucose, or appetite (Metformin is allowed if dose and weight are stable for at least 3 months);
- history of medication changes within 4 weeks of enrollment;
- active substance use;
- history of cardiovascular disease, gastrointestinal disorders, bariatric surgery, epilepsy, untreated thyroid disease;
- hematocrit >2% below normal;
- fasting glucose > 125 mg/dL or hemoglobin A1c ≥ 7% ;
- ALT or AST >2.5 times upper limit of normal;
- Cr >1.5 mg/dL; hyponatremia;
- pregnancy or breastfeeding;
- unwilling to use medically acceptable form of contraception (females only)
- follows a nonstandard diet (e.g., gluten free, pescatarian, vegetarian, vegan, Paleo, Atkins, raw diet, macrobiotic diet)
- current smoking or tobacco use
Data sourced from ClinicalTrials.gov (NCT03043053). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.