Could a diabetes drug help teens with rare obesity syndromes shed pounds?
NCT ID NCT06901245
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tests tirzepatide, a weight loss medication, in 36 young adults aged 18-26 with obesity from Prader-Willi syndrome, hypothalamic obesity, or general causes. Participants take the drug for 48 weeks to see how much weight they lose and how their health changes. The goal is to find if tirzepatide works as well for genetic or brain-injury-related obesity as it does for common obesity.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Tirzepatide
- What this could lead to
- If it works, this could point toward a weight management option for young adults with hard-to-treat obesity due to genetic or brain injury causes.
- What could go wrong
- This is a small, early-phase study with only 36 participants, so results may not apply widely. Tirzepatide may cause side effects like nausea or vomiting, and weight loss may not be sustained long-term.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 36 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 26 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Children's Minnesota
RECRUITINGSaint Paul, Minnesota, 55102, United States
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Seattle Children's Hospital
RECRUITINGSeattle, Washington, 98105, United States
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Vanderbilt University Medical Center
RECRUITINGNashville, Tennessee, 37203, United States
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Other studies related to the condition(s) this trial covers.
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- Can early parent coaching help infants with rare genetic disorders thrive?
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- Newborn screening study aims to catch rare diseases at birth
- Brain and eye clues to emotion recognition in autism and psychosis