NCT07091734

Tirzepatide for Partial Lipodystrophy Treatment: A New Horizon in 2024

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lipodystrophy, Partial

Interventions

Type	Name	Description
DRUG	Tirzepatide	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.
DRUG	Usual 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.

Timeline

• Start date: 2025-09-08
• Primary completion: 2029-09-01
• Completion: 2029-09-01
• First posted: 2025-07-29
• Last updated: 2025-09-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study