Oxytocin for Weight Loss in Adolescents

NCT04551482 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: 2020P0025111R01DK124223-01A1
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Body mass index (BMI)

  Mean difference in BMI between Oxytocin and Placebo group after 12 weeks of treatment. BMI will be calculated as weight/height2

  12 weeks

Secondary Outcomes (2)

• Lean mass and Fat mass

  12 weeks

• Fasting Resting Energy Expenditure (kCal)

  12 weeks

Study Arms (2)

Oxytocin

EXPERIMENTAL

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

Drug: Oxytocin nasal spray

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Oxytocin nasal spray DRUG

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

Also known as: Syntocin

Oxytocin

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• Weight \>450 lbs due to limits for MRI and DXA scanners
• Type 1 Diabetes Mellitus or Type 2 Diabetes Mellitus if HbA1c \>8%

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Elizabeth Lawson, MD, MMSc

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth A Lawson, MD, MMSc

CONTACT

617-726-3870; ealawson@partners.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 16, 2020
• Study Start: July 28, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: June 26, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Following publication and ending 36 months following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal will receive IPD to achieve aims in the approved proposal. Proposals should be directed to Drs. Lawson, Misra or Bredella. After approval, we will provide a copy of the requested data, as well as any additional required documentation, to the requesting researchers. The data will be housed on a secure password protected network drive at the MGH, that will be sent to investigators who ask for the data.

Locations

US (1)