Oxytocin for Weight Loss in Adolescents

Description

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.

Conditions

Obesity, Adolescent, Oxytocin

Study Overview

Study Details

Study overview

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.

Oxytocin as a Neuroendocrine Therapy for Obesity in Youth

Oxytocin for Weight Loss in Adolescents

Condition
Obesity, Adolescent
Intervention / Treatment

-

Contacts and Locations

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Males and Females, 12-18 years
  • * Obesity (BMI ≥95th percentile for age and gender)
  • * Willingness to maintain current diet and lifestyle for the duration of study participation
  • * 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

Ages Eligible for Study

12 Years to 18 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Massachusetts General Hospital,

Elizabeth Lawson, MD, MMSc, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

2027-03-31