NCT04551482 · Massachusetts General Hospital
Oxytocin for Weight Loss in Adolescents
What this study is about
This is a randomly assigned, double blind, compared against an inactive treatment study of the effects of intranasal oxytocin in youths with obesity, ages 10-18 years old. Subjects will be randomly assigned to receive intranasal oxytocin or placebo (1 spray per nostril, 4 times per day) for 12 weeks.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
Where
- Boston, Massachusetts
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 26, 2026 · Source of record for eligibility and locations