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RECRUITING
NCT07091734
PHASE2

Tirzepatide for Partial Lipodystrophy Treatment: A New Horizon in 2024

Sponsor: University of Michigan

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2025-09-08

Completion Date

2029-09

Last Updated

2025-09-09

Healthy Volunteers

No

Interventions

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.

Locations (1)

University of Michigan

Ann Arbor, Michigan, United States