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Could a diabetes drug help teens with rare obesity syndromes shed pounds?

NCT ID NCT06901245

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 36 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

18 to 26 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Children's Minnesota

    RECRUITING

    Saint Paul, Minnesota, 55102, United States

  • Seattle Children's Hospital

    RECRUITING

    Seattle, Washington, 98105, United States

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37203, United States

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