Actively Recruiting
Tirzepatide for Partial Lipodystrophy Treatment: A New Horizon in 2024
Led by University of Michigan · Updated on 2025-09-09
32
Participants Needed
1
Research Sites
207 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Tirzepatide for Partial Lipodystrophy Treatment: A New Horizon in 2024
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older with familial partial lipodystrophy diagnosis
- Hemoglobin A1c of 7.0% or higher at screening and after a 12-week run-in period
- Triglycerides of 200 mg/dL or higher at screening and after a 12-week run-in period
- Stable body weight (no more than 5% change) during the 3 months before screening
- Stable diet with no major changes in macronutrient composition for the 3 months prior
- Willingness and ability to comply with clinic visits and study procedures
You will not qualify if you...
- Diagnosis of generalized or acquired lipodystrophy
- Treatment with GLP-1 agonist or Tirzepatide within the past 6 months
- Treatment with metreleptin within the past 3 months
- Pancreatitis within the past 3 months
- History of bone marrow transplant, immune checkpoint inhibitor use, or CNS tumor involving the hypothalamus
- Use of weight loss medications within 3 months before screening
- Active treatment with oral glucocorticoids above 7.5 mg prednisone equivalents per day or plans to start such treatment during the study
- Treatment with oral estrogens, aromatase inhibitors, LHRH agonists, or systemic testosterone started within 6 months before screening
- Any malignancy within the past year except fully treated basal or squamous cell skin carcinomas or carcinoma in situ of cervix or anus
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia Type 2
- Recent serious heart conditions or procedures within 3 months before screening
- Advanced heart failure or severe uncontrolled hypertension
- Autoimmune Type 1 diabetes diagnosis
- HIV positivity or history
- Uncontrolled hepatitis B or C infection or active tuberculosis
- Participation in another investigational study within 3 months before screening
- Any illness or condition that may pose additional risk or confound results
- Excessive alcohol use (>21 drinks/week for males, >14 for females)
- Pregnant or breastfeeding persons; agreement to use effective contraception
- Male participants unwilling to use medically acceptable birth control during and after treatment
- Known serious allergy to Tirzepatide or its components
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
A
Adam Neidert, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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