Tirzepatide for Partial Lipodystrophy Treatment: A New Horizon in 2024

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 be willing and able to comply with clinic visits and study-related procedures (if patients cannot complete clinical outcomes assessments or unable to undergo magnetic resonance imaging (MRI), participants will not necessarily be excluded)

Locations
United States
Michigan
University of Michigan
RECRUITING
Ann Arbor
Contact Information
Primary
Adam Neidert, MS
aneidert@med.umich.edu
734-615-0539
Time Frame
Start Date: 2025-09-08
Estimated Completion Date: 2029-09
Participants
Target number of participants: 32
Treatments
Experimental: Tirzepatide then usual care (Group A)
Participants will have a 12-week run-in period and then recheck of eligibility. Eligible participants randomized to this group will receive Tirzepatide according to the dose titration plan described in the FDA-approved Prescribing Information (starting with 2.5 mg/week and increasing the dose every 4 weeks by increments of 2.5 milligrams (mg) for 24 weeks (up to 15 mg over the course of 6 months). Phase 2 weeks 25-48: Discontinuation of Tirzepatide (patients may continue on protocol if commercial use of GLP-1 receptor agonist is begun during this phase). Participants will continue the regular diabetic and hypertriglyceridemia medications that were used during the run-in period for weeks 25-48.
Experimental: Usual care treatment then Tirzepatide (Group B)
Participants will have a 12-week run-in period and then recheck of eligibility. Eligible participants randomized to this group will continue participant's regular diabetic and hypertriglyceridemia medications that were used during the run-in period for 24 weeks. During weeks 25-48 (phase 2) participants will receive Tirzepatide according to the dose titration plan described in the FDA-approved Prescribing Information (starting with 2.5 mg/week and increasing the dose every 4 weeks by increments of 2.5 milligrams (mg) for 24 weeks.
Sponsors
Leads: University of Michigan

This content was sourced from clinicaltrials.gov