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.
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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Subjects will take Tirzepatide for 48 weeks
Children's Minnesota
Saint Paul, Minnesota, United States
RECRUITINGVanderbilt University Medical Center
Nashville, Tennessee, United States
RECRUITINGSeattle Children's Hospital
Seattle, Washington, United States
RECRUITINGChange in weight
Weight will be measured in kilograms through anthropometric measurements. Change in percent weight from baseline to week 48 of treatment with tirzepatide in young adults with PWS, HO, GNSO and obesity will then be assessed.
Time frame: 48 weeks
Change in BMI
Change in BMI from baseline to 48 weeks of treatment with tirzepatide in young adults with PWS, HO, GNSO and obesity through anthropometric measurements. BMI will be calculated using weight (kg) and height (m) which will be combined to report BMI in kg/m\^2. The percent change in this BMI value from baseline to 48 weeks will be calculated.
Time frame: 48 weeks
Change in fat mass
Change in fat mass (measured in kg by DXA scan) from baseline to 48 weeks of treatment with tirzepatide in young adults with PWS, HO, GNSO and obesity.
Time frame: 48 weeks
Change in appetite - CoEQ (Control of Eating Questionnaire)
Change in appetite during 48 weeks of treatment with tirzepatide in young adults with PWS, HO, GNSO and obesity using an appetite questionnaire (CoEQ - Control of Eating Questionnaire). CoEQ is a 21-item scale to assess the severity and type of food cravings an individual experiences using a visual analog scale. Higher scores indicate higher severity of hyperphagia.
Time frame: 48 weeks
Change in appetite - Physician Rated Hyperphagia Severity Scale
Change in appetite during 48 weeks of treatment with tirzepatide in young adults with PWS, HO, GNSO and obesity assed with a physician rated hyperphagia severity scale. This is a 5 point scale (0 to 5) to rate clinical imppression of hyperphagia severity. Higher scores mean more severity.
Time frame: 48 weeks
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Change in metabolic markers - fasting lipids
Change in metabolic markers during 48 weeks of treatment with tirzepatide in young adults with PWS, HO, GNSO and obesity including: fasting lipids via lipid profile assay via blood sample
Time frame: 48 weeks
Change in metabolic markers - fasting plasma glucose
Change in metabolic markers during 48 weeks of treatment with tirzepatide in young adults with PWS, HO, GNSO and obesity including: fasting plasma glucose, via chemistry panel via blood sample
Time frame: 48 weeks
Change in metabolic markers- fasting insulin
Change in metabolic markers during 48 weeks of treatment with tirzepatide in young adults with PWS, HO, GNSO and obesity including: fasting insulin via insulin assay via blood sample
Time frame: 48 weeks
Change in metabolic markers - hemoglobin A1C
Change in metabolic markers during 48 weeks of treatment with tirzepatide in young adults with PWS, HO, GNSO and obesity including: hemoglobin A1C via hemoglobin A1C assay via blood sample
Time frame: 48 weeks
Change in metabolic markers- Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Change in metabolic markers during 48 weeks of treatment with tirzepatide in young adults with PWS, HO, GNSO and obesity including: Homeostatic Model Assessment of Insulin Resistance (HOMA-IR). This is product measuring insulin resistance calculated using fasting insulin and fasting glucose values. Higher numbers indicate more insulins resistance.
Time frame: 48 weeks