Obesity, Adolescent study: Oxytocin nasal spray
Official title Oxytocin for Weight Loss in Adolescents
ClinicalTrials.gov ID: NCT04551482
What this study is testing
What is Oxytocin nasal spray?
An investigational nasal spray being studied as a potential treatment for obesity in adolescents. It is designed to act as a hormone that helps regulate energy balance, which may reduce appetite and increase energy expenditure.
Also referred to as Syntocin.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether a nose spray called oxytocin helps with weight loss. It also checks how safe the spray is for teens.
- Who it's for
- You may be able to join if you are a teen between 10 and 18 years old with obesity.
- What's involved
- You would use a nose spray four times a day. You would also have check-ups to look at your health and habits.
- Time commitment
- The study lasts 12 weeks, plus a final check-up six weeks later.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 10 to 18
You may be able to join if
- 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
You likely can't join if
- 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...
- 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
See the full eligibility 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 10 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Boston, Massachusetts, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.