Tirzepatide in PWS, HO and GNSO
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-26
SponsorGrace Kim
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Tirzepatide
Treatment groups
36 Participants
are divided into 3 treatment groupsSponsors and collaborators
Grace Kim
Lead sponsor
Seattle Children's Hospital
Sponsor institution
Vanderbilt University Medical Center
Collaborator
Children's Hospitals and Clinics of Minnesota
Collaborator
Seattle Children's Hospital
Collaborator
Source ClinicalTrials.gov