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Oxytocin for Weight Loss in Adolescents

RecruitingPhase 2Ages 10 Years - 18 YearsAllMassachusetts General Hospital
NCT04551482 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Oxytocin nasal spray
  • Placebo
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Where

1 site
Massachusetts General Hospital
Boston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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