Recruiting

Tirzepatide

Sponsor:

Grace Kim

Code:

NCT06901245

Conditions

Prader-Willi Syndrome

Hypothalamic Obesity

Obesity/Therapy

Eligibility Criteria

Sex: All

Age: 18 - 26

Healthy Volunteers: Not accepted

Interventions

Tirzepatide

Study Details

Brief summary:

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.

Conditions

Prader-Willi Syndrome

Hypothalamic Obesity

Obesity/Therapy

Study ID

NCT06901245

Start date

May 1, 2025

Status verified date

Jan, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 26

Healthy Volunteers: Not accepted

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 Design

Enrollment

36 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Prader-Willi Syndrome

Individuals 18-26 years with a BMI in the obesity range (BMI ≥95th percentile for age and sex or ≥30 kg/m2) with genetically confirmed Prader-Willi Syndrome between 18-26 years old.

active comparator: Hypothalamic Obesity

Individuals 18-26 years with a BMI in the obesity range (BMI ≥95th percentile for age and sex or ≥30 kg/m2) and hypothalamic obesity as defined by damage to the medial hypothalamic region resulting in dysregulation of satiety and energy balance as diagnosed by a physician.

active comparator: General Non-Syndromic Obesity

Individuals 18-26 years with a BMI in the obesity range (BMI ≥95th percentile for age and sex or ≥30 kg/m2) and general obesity unrelated to a genetic syndrome or underlying medical condition.

Interventions

Tirzepatide

Subjects will take Tirzepatide for 48 weeks

Primary outcome measure

  • Change in weight [ Time Frame: 48 weeks ]

Central Contacts and Locations

Locations

Children's Minnesota

Recruiting

Saint Paul, Minnesota, United States, 55102

Contacts

Diabetes/Endocrinology Research Team

651-220-5730endocrineresearch@childrensmn.org

Principal Investigator:

Jennifer Abuzzahab, MD

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Martha Upchurch

6158754274martha.upchurch@vumc.org

Principal Investigator:

Ashley Shoemaker, MD

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

Contacts

Endocrine Research Team

206-987-2540EndocrineResearch@seattlechildrens.org

Principal Investigator:

Grace Kim, MD

More Information

Sponsor

Grace Kim

Last update posted

Sep 16, 2025

Last verified

Jan, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Grace Kim on 2025-09-16.