Tirzepatide in PWS, HO and GNSO

What Was Tested

This registered phase 4 trial tested Tirzepatide.

These groups will be given medication for 1 year to see how weight and other health factors are effected by the medication.

It had three arms (groups): Prader-Willi Syndrome (active comparator), Hypothalamic Obesity (active comparator) and General Non-Syndromic Obesity (active comparator).

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.

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.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 36 planned participants were the target.

It was open to people of any sex aged from 18 years up to 26 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 7 inclusion and 20 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

The Tirzepatide group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Tirzepatide study: the participants and staff both knew the treatment.

It started in 2025-05-01 with completion listed for 2026-06.

It ran at 3 sites in United States (3).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in weight (time frame: 48 weeks).

It also tracked 9 secondary outcomes, for example Change in BMI, Change in fat mass, Change in appetite - CoEQ (Control of Eating Questionnaire), Change in appetite - Physician Rated Hyperphagia Severity Scale, Change in metabolic markers - fasting lipids and Change in metabolic markers - fasting plasma glucose.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Tirzepatide in 36 people.

Its size is small, so on its own it can only give an early look.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tirzepatide compound page, all human trials.