Tirzepatide in PWS, HO and GNSO

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Prader-Willi Syndrome Hypothalamic Obesity Obesity/Therapy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Tirzepatide

Intervention Type DRUG

Subjects will take Tirzepatide for 48 weeks

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.

Group Type ACTIVE_COMPARATOR

Tirzepatide

Intervention Type DRUG

Subjects will take Tirzepatide for 48 weeks

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.

Group Type ACTIVE_COMPARATOR

Tirzepatide

Intervention Type DRUG

Subjects will take Tirzepatide for 48 weeks

Interventions

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Tirzepatide

Subjects will take Tirzepatide for 48 weeks

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

26 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No