RECRUITING

Tirzepatide in PWS, HO and GNSO

Conditions

Prader-Willi Syndrome Hypothalamic Obesity Obesity/Therapy Tirzepatide GLP1 Agonist Obesity General Obesity

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-03

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06901245

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 26 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Locations (Sites)

Children's Minnesota

Minneapolis, Minnesota, 55404

United States

Vanderbilt University Medical Center

Nashville, Tennessee, 37203

United States

Seattle Children's Hospital

Seattle, Washington, 98105

United States

Collaborators and Investigators

Sponsor: Grace Kim

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03

Study Completion Date2026-12

Study Record Updates

Study Start Date2025-03

Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

Tirzepatide
GLP1 Agonist
Obesity
Prader-Willi Syndrome
Hypothalamic Obesity
General Obesity

Additional Relevant MeSH Terms

Prader-Willi Syndrome
Hypothalamic Obesity
Obesity/Therapy