Tirzepatide for Weight Loss in Prader-Willi Syndrome and Obesity

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Grace Kim

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of 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 medication.

Research Team

Eligibility Criteria

This trial is for young adults with Prader-Willi Syndrome, hypothalamic obesity, or general obesity without a genetic syndrome. Participants will be given Tirzepatide for weight loss over a year to see its effects on weight and health.

Inclusion Criteria

Consistent caregiver if not independent

Stable diet and exercise regimen for at least 6 months prior to enrollment

Able to use contraceptive methods if able to conceive offspring to prevent unintentional pregnancy during the study

Exclusion Criteria

I am currently using or have recently used weight loss medications.

Significant weight change (>3% weight gain or loss) in the last 2 months prior to enrollment

Current pregnancy, desire to become pregnant within study period, or current lactation

Treatment Details

Interventions

• Tirzepatide (Other)

Trial Overview The study tests the effectiveness of Tirzepatide, a weight loss medication, in different groups: those with Prader-Willi Syndrome/hypothalamic obesity versus those with non-syndromic obesity.

Participant Groups

Group I: General Non-Syndromic Obesity Active Control 1 Intervention

Individuals 18-26 years with a BMI in the obesity range (BMI ≥95th percentile for age and sex or ≥30 kg/m2) and general obesity unrelated to a genetic syndrome or underlying medical condition.

Group II: Hypothalamic Obesity Active Control 1 Intervention

Individuals 18-26 years with a BMI in the obesity range (BMI ≥95th percentile for age and sex or ≥30 kg/m2) and hypothalamic obesity as defined by damage to the medial hypothalamic region resulting in dysregulation of satiety and energy balance as diagnosed by a physician.

Group III: Prader-Willi Syndrome Active Control 1 Intervention

Individuals 18-26 years with a BMI in the obesity range (BMI ≥95th percentile for age and sex or ≥30 kg/m2) with genetically confirmed Prader-Willi Syndrome between 18-26 years old.

Who Is Running the Clinical Trial?

Grace Kim

Lead Sponsor

Trials

1

Recruited

40+

Vanderbilt University Medical Center

Collaborator

Trials

922

Recruited

939,000+

Jeffrey R. Balser

Vanderbilt University Medical Center

Chief Executive Officer since 2009

MD and PhD from Vanderbilt University

Rick W. Wright

Vanderbilt University Medical Center

Chief Medical Officer since 2023

MD from University of Missouri-Columbia

Seattle Children's Hospital

Collaborator

Trials

319

Recruited

5,232,000+

Dr. Jeff Sperring

Seattle Children's Hospital

Chief Executive Officer since 2015

MD from Indiana University School of Medicine

Dr. Jeff Ojemann

Seattle Children's Hospital

Chief Medical Officer since 2022

MD from Washington University in St. Louis

Children's Hospitals and Clinics of Minnesota

Collaborator

Trials

67

Recruited

5,022,000+

Dr. Marc Gorelick

Children's Hospitals and Clinics of Minnesota

Chief Executive Officer since 2017

AB in History from Princeton University, MD from Duke University, MS in Clinical Epidemiology from the University of Pennsylvania

Dr. Emily Chapman

Children's Hospitals and Clinics of Minnesota

Chief Medical Officer

MD from Dartmouth Medical School