Tirzepatide in Special Populations

18 Mar Tirzepatide in Special Populations

Tirzepatide is an FDA-approved medication for the treatment of obesity. It has proven success for weight management populations with non-syndromic obesity. Special populations such as Prader-Willi Syndrome and Hypothalamic Obesity do not have FDA-approved medications for weight loss. In addition, these special populations have not responded to weight loss medications in the same way as populations with non-syndromic general obesity. The aim of this study is to assess the efficacy and safety of tirzepatide in special populations in comparison to general non-syndromic obesity. This will be a multi-site, open-label, non-randomized pilot study study focused on young adults 18-26 years of age with either Prader-Willi Syndrome, Hypothalamic Obesity or General Non-syndromic Obesity. This study will be a 48 week trial using trizepatide with an additional visit 8 weeks after stopping medication. It includes 6 in-person study visits and 4 telehealth visits. Research procedures will include: medical record review, physical exams, laboratory tests (blood draws and urine), DXA scans and questionnaires.

Participant Eligibility

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 1 year
– Current participation in an interventional clinical study
– Previous or planned surgical treatment for obesity
– Individuals with current substance abuse equivalent 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

Contact

Stephanie Purdy
(206) 987-2540