Tirzepatide in PWS, HO and GNSO
This research study is comparing the effectiveness of a weight loss medication called Tirzepatide in young adults with Prader-Willi Syndrome and/or hypothalamic obesity, as compared to young adults with obesity that is unrelated to a genetic syndrome or underlying medical cause. These groups will be given medication fo
| Condition(s) | Prader-Willi Syndrome, Hypothalamic Obesity, Obesity/Therapy |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| Summary | This research study is comparing the effectiveness of a weight loss medication called Tirzepatide in young adults with Prader-Willi Syndrome and/or hypothalamic obesity, as compared to young adults with obesity that is unrelated to a genetic syndrome or underlying medical cause. These groups will be given medication for 1 year to see how weight and other health factors are effected by the medication. |
| Who can participate | Inclusion Criteria: * Individuals 18-26 years with a BMI in the obesity range (BMI ≥95th percentile for age and sex or ≥30 kg/m2) with either 1) genetically confirmed diagnosis of PWS, 2) hypothalamic obesity as defined by damage to the medial hypothalamic region resulting in dysregulation of satiety and energy balance as diagnosed by a physician, 3) general obesity unrelated to a genetic syndrome or underlying medical condition * In a stable care setting at least 6 months prior to enrollment * Able and willing to participate in study visits including tolerating blood draws, urine samples and tolerate DXA scan. * Ability to take weekly subcutaneous tirzepatide * Consistent caregiver if they are not independent * Stable diet and exercise regimen for at least 6 months prior to enrollment * A |
| Ages | 18 Years to 26 Years |
| Sex | All |
| Lead sponsor | Grace Kim |
| Locations | Saint Paul, Minnesota, United States; Nashville, Tennessee, United States; Seattle, Washington, United States |
| Start date | 2025-05-01 |
| NCT ID | NCT06901245 |
| Official listing | https://clinicaltrials.gov/study/NCT06901245 |