NCT06901245

Tirzepatide in PWS, HO and GNSO

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Grace Kim · Academic / Other
• Sex: All
• Age: 18 Years – 26 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is for the following individuals: * Age 18-26. * Have Prader-Willi Syndrome, Hypothalamic Obesity, or Obesity unrelated to a genetic syndrome or medical condition. * Have a BMI in the obesity range If you/your child decide to take part in the research study, you/your child would participate in the study for approximately 56-60 weeks. During this time the following can be expected: * Receive tirzepatide for once-weekly dosing. * Complete 6 in-person SCH study visits * Complete 4 telehealth visits. * Complete the following research procedures: * Medical Record Review * Vital Signs * Anthropometry (e.g., height, weight, waist measurements) * Physical Exams * Laboratory Tests (e.g., fasting blood draws, urine test) * Dual-Energy Absorptiometry (DXA) scans * Questionnaires

Conditions

• Prader-Willi Syndrome
• Hypothalamic Obesity
• Obesity/Therapy

Interventions

Type	Name	Description
DRUG	Tirzepatide	Subjects will take Tirzepatide for 48 weeks

Timeline

• Start date: 2025-05-01
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2025-03-28
• Last updated: 2025-09-16

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study