Oxytocin for Weight Loss in Adolescents

Phase

Condition

Obesity

Diabetes Prevention

Treatment

Oxytocin nasal spray

Placebo

Clinical Study ID

NCT04551482

2020P002511

1R01DK124223-01A1

Ages 10-18
All Genders

Study 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 Criteria

Inclusion

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 studyparticipation

Exclusion

Exclusion Criteria:

Active substance abuse
Use of prescription or over-the-counter drugs or dietary/herbal supplements for thepurpose of weight loss. Medications/supplements that may affect weight will beallowed if participants are on a stable dose with stable weight for at least 3months.
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 ofnormal
Creatinine >1.5 mg/dl
Hyponatremia
Pregnancy/breastfeeding or refusal to use contraception not containing estrogenthroughout the study if female and sexually active
MRI exclusion criteria such as the presence of a pacemaker or cerebral aneurysmclips
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

Oxytocin nasal spray

July 28, 2021

March 31, 2027

Study 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.

Connect with a study center

Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Active - Recruiting

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