RecruitingPhase 2NCT04551482

Oxytocin for Weight Loss in Adolescents

Oxytocin as a Neuroendocrine Therapy for Obesity in Youth

Sponsor

Massachusetts General Hospital

Enrollment

75 participants

Start Date

Jul 28, 2021

Study Type

INTERVENTIONAL

Conditions

Obesity, Adolescent Oxytocin

Summary

This is a randomized, double blind, placebo-controlled study of the effects of intranasal oxytocin in youths with obesity, ages 12-18 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

Min Age: 10 YearsMax Age: 18 Years

Inclusion Criteria3

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 Criteria16

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
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