Recruiting
Phase 2

Oxytocin

Sponsor:

Massachusetts General Hospital

Code:

NCT04551482

Conditions

Obesity, Adolescent

Oxytocin

Eligibility Criteria

Sex: All

Age: 10 - 18

Healthy Volunteers: Not accepted

Interventions

Oxytocin nasal spray

Placebo

Study Details

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.

Conditions

Obesity, Adolescent

Oxytocin

Study ID

NCT04551482

Start date

Jul 28, 2021

Status verified date

Jun, 2026

Completion date

Feb 28, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 18

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

55 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Oxytocin

Oxytocin nasal spray (24 IU nasal spray, 4 times per day for 12 weeks)

placebo comparator: Placebo

Placebo nasal spray (24 IU nasal spray, 4 times per day for 12 weeks)

Interventions

Oxytocin nasal spray

24 IU nasal spray, 4 times per day for 12 weeks

Placebo

24 IU nasal spray, 4 times per day for 12 weeks

Primary outcome measure

  • Body mass index (BMI) [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Elizabeth A Lawson, MD, MMSc

617-726-3870ealawson@partners.org

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Elizabeth A Lawson, MD

ealawson@partners.org

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Jun 26, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-06-26.