Intranasal Oxytocin in Hypothalamic Obesity
Summary
This research study will test if oxytocin, delivered by nasal spray, will promote weight loss in children, adolescents, and adults with Hypothalamic Obesity as compared to a placebo. The study is divided into two parts. During the first part, subjects will receive either oxytocin or placebo. In the second part, subjects will "cross-over" to receive the other treatment - either oxytocin or placebo. During study visits participants will do blood tests, physical exams, metabolic testing, a MRI scan, and some surveys and questionnaires.
Timeline
- Start
- 2016-10
- Primary completion
- 2021-04
- Completion
- 2022-05
Outcome
Missed primary endpoint
registry MEDIAN Oxytocin: Change at 8 Weeks: 1.2 (0.9 to 1.8) kg NCT02849743 ↗
registry analysis (other test); Oxytocin vs Placebo; p = 0.92; Least Means Square -0.5; Regression, Linear NCT02849743 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Oxytocin | Peptide | 16 iu | Intranasal |
| Subject | Oxytocin | Peptide | 24 iu | Intranasal |