Who may be eligible for the Tirzepatide in PWS, HO and GNSO trial?

Inclusion Criteria: * 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 Criteria: * 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.

ClinicalTrials.gov record NCT06901245

Tirzepatide in PWS, HO and GNSO

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

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

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.

Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.

PhasePhase 4A study of a treatment that is already approved, to learn more about its long-term effects, safety or use in everyday practice.

Age18 years old to 26 years old

SexAll

LocationUnited States

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This interventional study gives once-weekly tirzepatide for 48 weeks to young adults (ages 18–26) in three groups: genetically confirmed Prader-Willi syndrome, hypothalamic obesity, or general non‑syndromic obesity. Participants are followed for about 56–60 weeks overall and have in-person and telehealth visits, scans, blood and urine tests, and questionnaires. The main measurement is change in weight at 48 weeks.

What it is studying. Whether and how once-weekly tirzepatide changes weight, body composition, appetite (including hyperphagia), and metabolic blood measures in young adults with PWS, hypothalamic obesity, or general obesity.

What the researchers hope to learn. Primary scientific goal: measure change in weight from baseline to 48 weeks of tirzepatide treatment. Secondary goals: measure changes in BMI, fat mass by DXA, appetite (Control of Eating Questionnaire and a physician-rated hyperphagia scale), and metabolic markers (fasting lipids, fasting glucose, fasting insulin, hemoglobin A1C, and HOMA-IR) over 48 weeks.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug: Tirzepatide

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

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 criteria

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.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants take once‑weekly tirzepatide injections for 48 weeks and are followed for about 56–60 weeks total. They will attend six in‑person study visits and four telehealth visits and have medical record review, physical exams, vital‑signs and anthropometric measurements (height, weight, waist), fasting blood draws and urine tests, DXA scans to measure fat mass, and questionnaires about appetite and health. Participants must be willing to receive weekly subcutaneous injections and tolerate blood draws and DXA scanning. Contraception is required for those who can become pregnant.

How the study is structured. A phase 4, non-randomized, open (non-masked) interventional study with three parallel groups. All participants receive weekly subcutaneous tirzepatide for 48 weeks; measurements (weight, DXA scans, blood tests, and questionnaires) are taken at baseline and during treatment. There is no placebo or blinded comparison.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on Prader-Willi syndrome

Clinical trials19 trials listed for Prader-Willi syndromeEvery trial the registry lists for Prader-Willi syndrome, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Prader-Willi syndrome researchLatest monthly update: September 2026. Includes: Hunger symptoms. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: May 1, 2025
Primary completion: June 2026 (estimated)
Study completion: December 2026 (estimated)
Target enrollment: 36 participants (estimated)
Last updated on registry: Sep 16, 2025
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: Grace Kim
Collaborators: Vanderbilt University Medical Center
Children's Hospitals and Clinics of Minnesota
Seattle Children's Hospital

Participating sites (3)

Children's MinnesotaRecruiting
Saint Paul, Minnesota, 55102 · United States
- Diabetes/Endocrinology Research Team · 651-220-5730 · endocrineresearch@childrensmn.org
- Jennifer Abuzzahab, MD
Vanderbilt University Medical CenterRecruiting
Nashville, Tennessee, 37203 · United States
- Martha Upchurch · 6158754274 · martha.upchurch@vumc.org
- Ashley Shoemaker, MD
Seattle Children's HospitalRecruiting
Seattle, Washington, 98105 · United States
- Endocrine Research Team · 206-987-2540 · EndocrineResearch@seattlechildrens.org
- Grace Kim, MD
- Parisa Salehi, MD
- Melinda Pierce, MD

Terms used on this page · explanations by MedicalUpdates.ai

enrollment: The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
study drug: A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
before screening: The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
endpoints: Something the study measures to judge its results, such as a symptom score, a blood test or survival. Outcomes are grouped as primary, secondary and sometimes exploratory.
Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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