Oxytocin for Weight Loss in Adolescents

Mass General Brigham

Status and phase: Enrolling; Phase 2

Conditions: Obesity, Adolescent; Oxytocin

Treatments: Drug: Placebo; Drug: Oxytocin nasal spray

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04551482

1R01DK124223-01A1 (U.S. NIH Grant/Contract)

2020P002511

Details and patient eligibility

About

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 (3 sprays 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.

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion 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

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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 2 patient groups, including a placebo group

Oxytocin

Experimental group

Description:

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

Treatment:

Drug: Oxytocin nasal spray

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo