Tirzepatide for Prader-Willi Syndrome and Obesity

Tirzepatide in PWS, HO and GNSO

Recruiting Phase 4 Interventional Study
Prader-Willi Syndrome Hypothalamic Obesity Obesity/Therapy
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 26
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
36 (estimated)
Sponsor
Grace Kim · Other
Who this trial is looking for

This trial is looking for young adults aged 18 to 26 with obesity, Prader-Willi Syndrome, or hypothalamic obesity. Participants will take a weight loss medication called Tirzepatide for one year to see how it affects their weight and health.

Are You a Good Fit for This Trial?
Must not be taking InsulinSulfonylureaGLP1A inhibitorsDPP4 inhibitors
Rules you out PregnancyPancreatitisChronic kidney diseaseMedullary thyroid carcinomaUncontrolled diabetes

You may be able to join if

  • I am 18 to 26 years old.
  • I have obesity or a diagnosis of Prader-Willi Syndrome or hypothalamic obesity.
  • I have been in a stable care setting for at least 6 months.
  • I can tolerate blood draws and other study visits.
  • I can take weekly injections of Tirzepatide.
  • I have a consistent caregiver if I am not independent.
  • I have maintained a stable diet and exercise for at least 6 months.
  • I can use contraception if I can get pregnant.

You may not be able to join if

  • I have used weight loss medications in the last 3 months.
  • I am currently using insulin or certain other diabetes medications.
  • I have had significant weight changes in the last 2 months.
  • I am pregnant or planning to become pregnant during the study.
  • I have a history of pancreatitis or certain kidney conditions.
  • I have uncontrolled diabetes.
  • I have any significant heart, kidney, or liver disease.
  • I have had cancer in the last 5 years.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 medicati…
Trial Locations
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Eligibility Criteria
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 satie…
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