Tirzepatide for Partial Lipodystrophy Treatment: A New Horizon in 2024
University of Michigan
Summary
This study aims to see if the clinical use of Tirzepatide in patients with lipodystrophy (a rare disorder associated with abnormal loss of the body's fat tissue) may lead to improved diabetes mellitus control and lowering of participant's triglycerides through the reduction of caloric intake. Study Hypothesis: \- The clinical use of Tirzepatide in patients with lipodystrophy may lead to favorable outcomes through the reduction of caloric intake.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients (≥18 years old) with a diagnosis of familial partial lipodystrophy (per protocol) * Hemoglobin A1c ≥ 7.0% at screening and after 12-week run-in period and * Triglycerides ≥ 200 Milligrams Per Deciliter (mg/dL) at screening and after 12-week run-in period * Stable body weight during the 3 months prior to screening visit (no gain or loss of \>5% current body weight) * Diet must have been stable for the prior 3 months (i.e., no major change in macronutrient composition, e.g. starting or stopping diets such as Atkins, paleo, vegetarianism, veganism) * Patients must…
Interventions
- DrugTirzepatide
Participants will receive study drug (Tirzepatide) according to the dose titration plan described in the FDA-approved Prescribing Information (starting with 2.5 mg/wk and increasing the dose every 4 weeks by increments of 2.5 mg. Additionally, participants will have visits (virtual or remote visits every four weeks) as well as various tests and evaluations during the trial.
- DrugUsual care medications
Participant's will continue on participant's regular diabetic and hypertriglyceridemia medications that were used during the run-in period for 24 weeks. This will be either Phase 1 or Phase 2 based on randomization. Additionally, participants will have visits (virtual or remote visits every four weeks) as well as various tests and evaluations during the trial.
Location
- University of MichiganAnn Arbor, Michigan