The Effects of Tirzepatide in Young Adults With Prader-Willi Syndrome, Hypothalamic Obesity and General Non-Syndromic Obesity

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 26
Healthy Volunteers: f
View:

• 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

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

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

Locations
United States
Minnesota
Children's Minnesota
RECRUITING
Saint Paul
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Washington
Seattle Children's Hospital
RECRUITING
Seattle
Time Frame
Start Date: 2025-05-01
Estimated Completion Date: 2026-12
Participants
Target number of participants: 36
Treatments
Active_comparator: Prader-Willi Syndrome
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.
Active_comparator: Hypothalamic Obesity
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.
Active_comparator: General Non-Syndromic Obesity
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.
Related Therapeutic Areas
Sponsors
Collaborators: Vanderbilt University Medical Center, Children's Hospitals and Clinics of Minnesota, Seattle Children's Hospital
Leads: Grace Kim

This content was sourced from clinicaltrials.gov