A study testing whether a new weekly shot from Grace Kim, tirzepatide, works for this condition.
- Who can join
- Adults 18 to 26, have prader-willi syndrome, BMI 30+.
- What you take
- tirzepatide, given as part of the study at no cost to you. Some participants may receive a placebo (an inactive version) instead, decided at random.
- How long it lasts
- The full study runs about 1.6 years; your own time in it is usually shorter.
- What you get
- The study medication and study-related care at no cost. Compensation varies by study site; many cover travel and provide the study medication at no cost. The trial coordinator will explain what that site offers before you join.
What this study is for
Primary condition: Prader-Willi Syndrome. Also studied in: Hypothalamic Obesity, Obesity/Therapy.
Full scientific study title: Tirzepatide in PWS, HO and GNSO.
Who can join
Adults 18 to 26, have prader-willi syndrome, BMI 30+. A site coordinator confirms whether you qualify during a free screening visit. The exact medical requirements are below.
Full medical eligibility (for you and your doctor)verbatim from the registry
This is the exact wording from ClinicalTrials.gov, including clinical measures (lab values, imaging scores). Bring it to your doctor if any of it is unclear.
Key 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
Key exclusion criteria
- Current or recent (within 3 months of start of study drug initiation) use of weight loss medications
- Current use of insulin or sulfonylurea or other medication affecting insulin secretion or GLP1 clearance
- Current or prior use of any GLP1A or DPP4 inhibitor during the 6 months before screening
- Any medications that may affect the study endpoints
- Significant weight change (>3% weight gain or loss) in the last 2 months prior to enrollment
Where this study is enrolling
This trial has 3 sites across 3 states. Contact a site coordinator directly to start screening.
Minnesota1 site
- Children's MinnesotaSaint Paul, Minnesota
Tennessee1 site
- Vanderbilt University Medical CenterNashville, Tennessee
Washington1 site
- Seattle Children's HospitalSeattle, Washington
Timeline
Started enrolling: 2025-05-01. Expected completion: 2026-12. Last updated on ClinicalTrials.gov: 2025-09-16.
Official source
We sync this data quarterly from ClinicalTrials.gov, the federal registry for clinical research. Before contacting a site, verify the trial is still recruiting on the official page:
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