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Tirzepatide for Partial Lipodystrophy Treatment: A New Horizon in 2024

NCT07091734 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-09-09

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Elif Oral, MD · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-08
Primary Completion
2029-09-30
Completion
2029-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07091734 on ClinicalTrials.gov