Actively Recruiting
Tirzepatide in PWS, HO and GNSO
Led by Grace Kim · Updated on 2025-09-16
36
Participants Needed
3
Research Sites
82 weeks
Total Duration
On this page
Sponsors
G
Grace Kim
Lead Sponsor
V
Vanderbilt University Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Tirzepatide in PWS, HO and GNSO
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals 18-26 years with a BMI in the obesity range (BMI 6395th percentile for age and sex or 6330 kg/m2) with either 1) genetically confirmed diagnosis of PWS, 2) hypothalamic obesity diagnosed by a physician due to medial hypothalamic damage, or 3) general obesity unrelated to a genetic syndrome or medical condition
- Stable care setting for at least 6 months before enrollment
- Able and willing to participate in study visits including tolerating blood draws, urine samples, and DXA scan
- Ability to take weekly subcutaneous tirzepatide
- Consistent caregiver if not independent
- Stable diet and exercise routine for at least 6 months before enrollment
- Able to use contraceptive methods to prevent pregnancy during the study if able to conceive
You will not qualify if you...
- Use of weight loss medications within 3 months before starting study drug
- Current use of insulin, sulfonylurea, or other medications affecting insulin secretion or GLP1 clearance
- Use of GLP1A or DPP4 inhibitors within 6 months before screening
- Use of any medications that may affect study endpoints
- Significant weight change (>3% gain or loss) in the 2 months before enrollment
- Change in dose of chronic endocrine medications >10%/kg/day for at least 3 months before study
- Current pregnancy, desire to become pregnant during study, or current lactation
- History of recurrent pancreatitis, chronic kidney disease, or gastroparesis
- Chronic or acute heart, kidney, or liver disease
- Personal or family history of medullary thyroid carcinoma or MEN syndrome type 2
- Uncontrolled diabetes (A1C >8.5%)
- Deep vein thrombosis
- Cancer within the previous 5 years
- Current participation in another interventional clinical study
- Previous or planned surgical treatment for obesity
- Moderate or severe substance abuse per DSM 5 criteria
- Suicidal ideation in the past year
- Unable to perform study procedures
- Body size that prevents accurate DXA measurements
- Any condition preventing successful study participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Children's Minnesota
Saint Paul, Minnesota, United States, 55102
Actively Recruiting
2
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37203
Actively Recruiting
3
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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