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Tirzepatide for Prader-Willi Syndrome, Hypothalamic Obesity, and General Obesity

This research study is looking at how a medication called Tirzepatide affects weight in young adults. It includes individuals aged 18 to 26 who have Prader-Willi Syndrome (a genetic condition affecting development), hypothalamic obesity (obesity due to brain damage affecting hunger), or general obesity not caused by a specific genetic problem. Participants will take Tirzepatide for 48 weeks. The main goal is to see how much weight changes after this time. The study aims to compare the effects of Tirzepatide across these different groups. The current status of this study is unclear, and it plans to enroll 36 participants.

Study design
This is an interventional study planning to enroll 36 participants aged 18-26. It will compare the effects of Tirzepatide in different groups of young adults with obesity.
What's involved
If you join, you would participate for about 56-60 weeks, receiving weekly Tirzepatide doses. You would have 6 in-person visits and 4 telehealth visits, including medical record reviews, vital signs, measurements, physical exams, lab tests, DXA scans, and questionnaires.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for measuring weight change is at 48 weeks, which is the duration of the intervention.

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NCT06901245

Tirzepatide in PWS, HO and GNSO

Recruiting
PHASE4Ages 18–26InterventionalTreatment
Grace Kim
~36 participants
Updated 2025-09-16 on ClinicalTrials.gov
What's tested:Tirzepatide

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in weight
Measured over 48 weeks

Conditions

Prader-Willi Syndrome
Hypothalamic Obesity
Obesity/Therapy

Explore related trials

Hypothalamic ObesityObesityPrader-Willi Syndrome

Where it's being run

3 sites across 3 states
Minnesota1
Tennessee1
Washington1

Who to contact

Diabetes/Endocrinology Research Team
[email protected]
651-220-5730
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

Current or recent (within 3 months of start of study drug initiation) use of weight loss medications
Current use of insulin or sulfonylurea or other medication affecting insulin secretion or GLP1 clearance
Current or prior use of any GLP1A or DPP4 inhibitor during the 6 months before screening
Any medications that may affect the study endpoints
Significant weight change (\>3% weight gain or loss) in the last 2 months prior to enrollment
Change in dose of chronic endocrine medications (testosterone, estrogen, levothyroxine, or growth hormone medications) \>10%/kg/day for at least 3 months prior to study
Current pregnancy or desire to become pregnant within study period, current lactation
History of recurrent pancreatitis, CKD, gastroparesis
Chronic/acute heart, kidney, or liver disease
Personal or family history of medullary thyroid carcinoma or MEN syndrome type 2
Uncontrolled diabetes (A1C \>8.5%)
DVT
Cancer within the previous 5 years
Current participation in an interventional clinical study
Previous or planned surgical treatment for obesity
Individuals with current substance abuse equivalnt to moderate or severe based on DSM 5 criteria (Hasin DS, 2013)
Any suicidal ideation in the past year
Unable to perform any of the procedures for the study
Have a body weight, height, and/or width that that prohibits the ability to obtain accurate measurements according to the DXA manufacturer's specification
Any condition that would prevent successful participation in the study.

What this trial measures

  • Change in weight48 weeks

    Weight will be measured in kilograms through anthropometric measurements. Change in percent weight from baseline to week 48 of treatment with tirzepatide in young adults with PWS, HO, GNSO and obesity will then be assessed.