Actively Recruiting
The Effects of Tirzepatide in Young Adults With Prader-Willi Syndrome, Hypothalamic Obesity, and General Non-Syndromic Obesity
Led by Grace Kim · Updated on 2025-09-16
36
Participants Needed
3
Research Sites
26 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
Researchers are evaluating the effects of the weight loss medication Tirzepatide in young adults aged 18 to 26 years with Prader-Willi Syndrome, Hypothalamic Obesity, or general obesity unrelated to genetic syndromes or medical conditions. The study compares how Tirzepatide influences weight and other health factors across these groups. Participants have a body mass index (BMI) in the obesity range. Participants will receive Tirzepatide once weekly for 48 weeks as part of the study. The study includes three groups based on their obesity type: those with genetically confirmed Prader-Willi Syndrome, those diagnosed with hypothalamic obesity by a physician, and those with general non-syndromic obesity. The study involves six in-person visits and four telehealth visits over approximately 56 to 60 weeks. Throughout the study, participants will undergo medical record reviews, vital sign checks, physical exams, and anthropometric measures such as height, weight, and waist circumference. Laboratory tests including fasting blood draws and urine tests, as well as Dual-Energy Absorptiometry (DXA) scans and questionnaires, will be completed. Researchers will monitor changes in weight, BMI, fat mass, appetite, and various metabolic markers. The primary outcome is weight change after 48 weeks of treatment.
CONDITIONS
Brief Title
Tirzepatide in PWS, HO and GNSO
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals aged 18 to 26 years with a BMI in the obesity range (≥95th percentile for age and sex or ≥30 kg/m2) and either a genetically confirmed diagnosis of Prader-Willi Syndrome, hypothalamic obesity diagnosed by a physician, or general obesity unrelated to genetic syndromes or medical conditions
- 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 scans
- Ability to take weekly subcutaneous Tirzepatide injections
- Consistent caregiver support if not independent
- Stable diet and exercise regimen for at least 6 months before enrollment
- Use of contraceptive methods if able to conceive during the study period
You will not qualify if you...
- Current or recent (within 3 months) use of weight loss medications
- 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
- Changes in dose of chronic endocrine medications by more than 10% per kg per day in the 3 months before study
- Current pregnancy, desire to become pregnant during the 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 past 5 years
- Current participation in another interventional clinical study
- Previous or planned surgical treatment for obesity
- Moderate or severe substance abuse based on DSM 5 criteria
- Any suicidal ideation in the past year
- Unable to perform study procedures
- Body size preventing accurate measurements per DXA specifications
- Any condition preventing successful study participation
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 48 weeks
Participants receive once-weekly doses of Tirzepatide for 48 weeks.
6 in-person visits and 4 telehealth visits
Duration - Approximately 6 to 8 weeks
Participants are monitored after completing treatment to assess ongoing effects and safety.
No specific visits detailed
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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