Oxytocin for Weight Loss in Adolescents (NCT04551482) | Clinical Trial Compass
RecruitingPhase 2
Oxytocin for Weight Loss in Adolescents
United States55 participantsStarted 2021-07-28
Plain-language 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.
Who can participate
Age range
10 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.