Oxytocin for Weight Loss in Adolescents

Oxytocin as a Neuroendocrine Therapy for Obesity in Youth

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity, Adolescent; Oxytocin
• Intervention / Treatment: Drug: Oxytocin nasal spray; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Elizabeth A Lawson, MD, MMSc; Phone Number: 617-726-3870; Email: ealawson@partners.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Elizabeth A Lawson, MD; Email: ealawson@partners.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 DM or type 2 Diabetes Mellitus if HbA1c >8%
• Active eating disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oxytocin; Oxytocin nasal spray (24 IU nasal spray, 4 times per day for 12 weeks)	Drug: Oxytocin nasal spray; 24 IU nasal spray, 4 times per day for 12 weeks; Other Names: Syntocin
Placebo Comparator: Placebo; Placebo nasal spray (24 IU nasal spray, 4 times per day for 12 weeks)	Drug: Placebo; 24 IU nasal spray, 4 times per day for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Mean difference in weight between Oxytocin and Placebo group after 12 weeks of treatment	12 weeks
Height	Measure height on a stadiometer to the nearest 0.1 cm	Baseline
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lean mass and Fat mass	Dual Energy Absorptiometry (DXA) will be used for measuring fat mass (kg) and lean mass (Kg)	12 weeks
Fasting Resting Energy Expenditure (kCal)	Assessed by Indirect calorimetry	12 weeks

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Elizabeth Lawson, MD, MMSc, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2021
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: August 31, 2020
• First Submitted That Met QC Criteria: September 10, 2020
• First Posted (Actual): September 16, 2020

Study Record Updates

• Last Update Posted (Estimated): December 7, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity; Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: 2020P002511

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No