Tirzepatide in PWS, HO and GNSO

Part of paid clinical trials in Saint Paul, Minnesota.

Sponsor
Grace Kim
Study ID
NCT06901245
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Hypothalamic Obesity
  • Obesity/Therapy
  • Prader-Willi Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - 26 Years
Healthy Volunteers
Not accepted

Interventions

  • Tirzepatide — DRUG
    Subjects will take Tirzepatide for 48 weeks

Study Details

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.

Key Dates

Start date
May 1, 2025
Status verified
Jan 2025
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
36 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Change in weight [ Time Frame: 48 weeks ]

Locations (3)

FacilityCityStateZIPSite coordinators
Children's MinnesotaSaint PaulMinnesota55102
Diabetes/Endocrinology Research Team
[email protected]
651-220-5730
Jennifer Abuzzahab, MD (PRINCIPAL_INVESTIGATOR)
Vanderbilt University Medical CenterNashvilleTennessee37203
Martha Upchurch
[email protected]
6158754274
Ashley Shoemaker, MD (PRINCIPAL_INVESTIGATOR)
Seattle Children's HospitalSeattleWashington98105
Endocrine Research Team
[email protected]
206-987-2540
Grace Kim, MD (PRINCIPAL_INVESTIGATOR)
Parisa Salehi, MD (SUB_INVESTIGATOR)
Melinda Pierce, MD (SUB_INVESTIGATOR)

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Children's Minnesota· Saint Paul, MNVanderbilt University Medical Center· Nashville, TNSeattle Children's Hospital· Seattle, WA

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