DRUG
Oxytocin nasal spray
24 IU nasal spray, 4 times per day for 12 weeks
Status
Recruiting
Phase
Phase 2
Enrollment
55
Locations
1
Results
Not posted
Publications
0
Study 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.
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 10-18-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.
Interventions
DRUG
24 IU nasal spray, 4 times per day for 12 weeks
DRUG
24 IU nasal spray, 4 times per day for 12 weeks
Timeline
First posted
Sep 16, 2020
Study start
Jul 28, 2021
Primary completion
Dec 31, 2026
Study completion
Feb 28, 2027
Results posted
Not reported
Registry updated
Jun 26, 2026
Outcomes
Body mass index (BMI)
Time frame · 12 weeks
Mean difference in BMI between Oxytocin and Placebo group after 12 weeks of treatment. BMI will be calculated as weight/height2
Lean mass and Fat mass
Time frame · 12 weeks
Dual Energy Absorptiometry (DXA) will be used for measuring fat mass (kg) and lean mass (Kg)
Fasting Resting Energy Expenditure (kCal)
Time frame · 12 weeks
Assessed by Indirect calorimetry
Eligibility
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: * 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 * 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
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
Massachusetts General Hospital
Boston, Massachusetts, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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