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TILT-2024

RecruitingPhase 2

Tirzepatide for Partial Lipodystrophy Treatment: A New Horizon in 2024

Lead sponsor

University of Michigan

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Diabetes (other / unspecified), Dyslipidemia

Key I/E criterion

•HbA1c ≥7%

Primary endpoints

•BMI, change•HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07091734

Org study IDHUM00251971

Timeline

Milestones

Study first posted2025-07-29actual

Study start2025-09-08actual

Last update posted2025-09-09actual

Primary completion2029-09estimated (month precision)

Study completion2029-09estimated (month precision)

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Diabetes (other / unspecified)Dyslipidemia

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•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)

Exclusion criteria

•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

•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

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition

Glycemic / diabetes

Weight & body composition

1 endpoint

Primary/protocol endpoint

Change in Body Mass Index (BMI) from baseline in Group A (Tirzepatide-treated) versus Group B (control) at 24 weeks

Time frame:Baseline, 24 weeks

BMI, change

change from baseline, improvement

Glycemic / diabetes

1 endpoint

Primary/protocol endpoint

Change in Hemoglobin A1c from baseline in Group A (Tirzepatide-treated) versus Group B (control) at 24 weeks

Time frame:Baseline, 24 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.