Oxytocin for Weight Loss in Adolescents

NCT ID: NCT04551482

Last Updated: 2025-07-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-28
• Study Completion Date: 2027-03-31

Brief 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.

Detailed Description

In recent years there has been a dramatic increase in obesity and its complications in both children and adults. Earlier treatment substantially reduces the likelihood of developing complications later in life while concurrently improving quality of life and decreasing mortality. Therefore, it is essential to develop safe and effective therapeutic strategies for weight loss, particularly in adolescents. Oxytocin (OXT), a hypothalamic peptide hormone that regulates energy balance, is a novel neuroendocrine weight-loss therapeutic in adults with obesity because it simultaneously reduces energy intake and increases energy expenditure and is well-tolerated. Data are currently lacking regarding effects of OXT administration in adolescents with obesity.

The current study is a 12-week randomized controlled trial (RCT) of OXT vs. placebo in 12-18-year old adolescents with obesity. We hypothesize that OXT administration will decrease weight as a consequence of decreased caloric intake and increased energy expenditure, both partially mediated by reduced hypothalamic inflammation (such inflammation drives weight gain by increasing food intake and reducing energy expenditure). Further, OXT will improve metabolic risk markers, such as visceral and intrahepatic fat, systemic inflammation, and serum lipids.

Conditions

Obesity, Adolescent; Oxytocin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Oxytocin

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

Group Type: EXPERIMENTAL

Oxytocin nasal spray

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Syntocin

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth Austen Lawson

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elizabeth Lawson, MD, MMSc

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Elizabeth A Lawson, MD, MMSc

Role: CONTACT

ealawson@partners.org

617-726-3870

Facility Contacts

Elizabeth A Lawson, MD

Role: primary

ealawson@partners.org

Other Identifiers

1R01DK124223-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2020P002511

Identifier Type: -

Identifier Source: org_study_id