The Effects of Tirzepatide in Young Adults With Prader-Willi Syndrome, Hypothalamic Obesity and General Non-Syndromic Obesity
Grace Kim
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.
Description
This study is for the following individuals: * Age 18-26. * Have Prader-Willi Syndrome, Hypothalamic Obesity, or Obesity unrelated to a genetic syndrome or medical condition. * Have a BMI in the obesity range If you/your child decide to take part in the research study, you/your child would participate in the study for approximately 56-60 weeks. During this time the following can be expected: * Receive tirzepatide for once-weekly dosing. * Complete 6 in-person SCH study visits * Complete 4 telehealth visits. * Complete the following research procedures: * Medical Record Review * Vital S…
Eligibility
- Age range
- 18–26 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugTirzepatide
Subjects will take Tirzepatide for 48 weeks
Locations (3)
- Children's MinnesotaSaint Paul, Minnesota
- Vanderbilt University Medical CenterNashville, Tennessee
- Seattle Children's HospitalSeattle, Washington