Lipodystrophy, PartialPhase 2TILT-2024NCT07091734
Tirzepatide for Partial Lipodystrophy Treatment: A New Horizon in 2024
A Phase 2 study testing Tirzepatide in people with Lipodystrophy, Partial, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lipodystrophy, Partial
- What is being tested?
- Tirzepatide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2025to Sep 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Diagnosis of generalized lipodystrophy or acquired lipodystrophy
- Having received treatment with a Glucagon-like peptide (GLP) -1 agonist or Tirzepatide within the past 6 months
- History of previous treatment with metreleptin within the past 3 months
- Pancreatitis within the past 3 months
- Patients with a medical history of bone morrow transplant, use of an immune check-point inhibitor, or central nervous system tumor involving the hypothalamus
- Treatment with of receiving over the counter or prescription medications for weight loss within 3 months prior to the screening visit
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- Active treatment with oral glucocorticoids >7.5 milligram (mg) prednisone equivalents per day or plans to begin treatment with oral glucocorticoids >7.5 mg prednisone equivalents per day during the study period
- Treatment with oral estrogens, aromatase inhibitors, Luteinizing hormone-releasing hormone (LHRH) agonists or systemic testosterone begun within 6 months prior to the screening visit
- Any malignancy, e.g., lymphoma, within the past 1 year, prior to screening visit except for fully treated basal cell or squamous epithelial cell carcinomas of the skin or carcinoma in situ of the cervix or anus
- A personal or family history of medullary thyroid carcinoma (MTC) or in patients with multiple endocrine neoplasia Type 2 (MEN 2)
- History of heart failure hospitalization, myocardial infarction, stroke, clinically significant arrhythmia (e.g., ventricular tachycardia, or any arrhythmia requiring medication adjustment to control), transient ischemic attack, unstable angina, percutaneous or surgical revascularization procedure (coronary, carotid, or peripheral vascular), or intracardiac device placement (e.g., pacemaker) within 3 months before the screening visit
- Advanced heart failure (New York Heart Association Class 3 to 4) or severe and uncontrolled hypertension
- Current diagnosis of autoimmune Type 1 diabetes mellitus
- History of human immunodeficiency virus (HIV) positivity or HIV positive at screening (to exclude HIV associated lipodystrophy).
- Uncontrolled infection with hepatitis B or hepatitis C infection or known active tuberculosis by history at screening
- A patient that has a documented, positive reverse-transcriptase polymerase chain reaction (RT-PCR) or serology test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) may be enrolled provided the patient has recovered from Coronavirus disease (COVID-19) (all COVID-19-related symptoms and have no major clinical findings which can potentially affect the safety of the patient)
- Participation in any clinical research study evaluating an investigational product (IP) or therapy within 3 months and less than 5 half-lives of IP prior to the screening visit. Participation in clinical research studies that only involve procedures (e.g., muscle biopsies, glycemic clamps) or testing (eg, MRI) that will not interfere with the current study is permitted
- Any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study
- Alcohol consumption >21 drinks per week for males or >14 drinks per week for females
- Pregnant or breastfeeding persons. Patients, if engaged in sexual relations with/and of childbearing potential, must agree to use a highly effective contraceptive method from the time of signing the informed consent form until at least 4 weeks after the last dose of study drug
- Sexually active adult men that are unwilling to use the following forms of medically acceptable birth control during the study drug treatment period and for 16 weeks after the last dose of study drug: vasectomy with medical assessment of surgical success OR consistent use of a condom. Sperm donation is prohibited during the study and for 16 weeks after the last dose of study drug
- Known serious hypersensitivity to Tirzepatide or any of the excipients in Mounjaro
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Adam Neidert, MS, 734-615-0539, aneidert@med.umich.edu
Elif Oral, MD
About this study
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
- Being tested
- Tirzepatide, Usual care medications
- Keywords
- Tirzepatide
- Medical subject headings
- Lipodystrophy, Partial, Acquired
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
Also called Mounjaro
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.
Usual care medicationsDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Tirzepatide then usual care (Group A) | Experimental | 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. Receives: Drug: Tirzepatide; Drug: Usual care medications |
| Usual care treatment then Tirzepatide (Group B) | Experimental | 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. Receives: Drug: Tirzepatide; Drug: Usual care medications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Mass Index (BMI) from baseline in Group A (Tirzepatide-treated) versus Group B (control) at 24 weeks
Height and weight will be collected to calculate BMI.
Measured: Baseline, 24 weeks
Change in Hemoglobin A1c from baseline in Group A (Tirzepatide-treated) versus Group B (control) at 24 weeks
The A1c is a blood test.
Measured: Baseline, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start8 Sep 2025
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lipodystrophy, PartialStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a randomized controlled, open label, delayed onset cross-over study.
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Oral, University of Michigan
- Investigators
- Elif Oral, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07091734
- Sponsor's protocol ID
- HUM00251971
- Acronym
- TILT-2024
- Status last verified
- Sep 2025
- First submitted
- 21 Jul 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Publication of data shall occur during the project, if appropriate, or at the end of the project, consistent with normal scientific practices. Research data that documents, supports, and validates research findings will be made available after the main findings from the final research data set have been accepted for publication. Such research data will be redacted to prevent the disclosure of personal identifiers. The study data will be submitted to the Central Biorepository at the University of Michigan or the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Central Repository when appropriate. Transcriptomic datasets that can be shared will be deposited in Gene Expression Omnibus (GEO, National Center for Biotechnology Information). Clinical and phenotypic datasets will be associated with the ribonucleic acid (RNA) sequencing submission to GEO.