A study testing whether a new weekly shot, tirzepatide, can help people with Prader-Willi syndrome lose weight.

Recruiting now. Registry record last updated September 16, 2025.

Who can join
Adults 18 to 26, have Prader-Willi syndrome, BMI 30+.
What you take
tirzepatide, given as part of the study. Check ClinicalTrials.gov for this trial's study groups, including any placebo or comparison medicine.
How long it lasts
The full study runs about 1.6 years; your own time in it is usually shorter.
What you get
Many clinical trials pay for the study medication and the study visits. Some also pay for travel. Ask the study team what this one covers before you sign the consent form.
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Phase Phase 4Sponsor Grace KimDrug tirzepatideClass GLP-1/GIPSites 3 USEnrollment target 36

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

Age18 to 26SexAnyBMI30 or higher

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 trial is enrolling

This trial has 3 sites across 3 states. Contact a site coordinator directly to start screening.

Minnesota1 site
Tennessee1 site
Washington1 site

Timeline

Started enrolling: May 1, 2025. Expected completion: December 2026. Last updated on ClinicalTrials.gov: September 16, 2025.

Official source

Every Monday we check this trial against ClinicalTrials.gov, the federal registry for clinical research. Last checked August 21, 2026. Confirm the current status there before you contact a site:

View on ClinicalTrials.gov →

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