Tirzepatide to improve blood sugar and triglycerides in partial lipodystrophy
Tirzepatide for Partial Lipodystrophy Treatment: A New Horizon in 2024
This trial will see if tirzepatide can help adults with familial partial lipodystrophy lower blood sugar and triglycerides by reducing how much they eat.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Drugs / interventions | prednisone |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT07091734 on ClinicalTrials.gov |
What this trial studies
This Phase 2 interventional study will give tirzepatide alongside participants' usual care medications to adults with familial partial lipodystrophy who have elevated HbA1c and triglycerides. A 12-week run-in period confirms stable diet, weight, HbA1c (≥7.0%) and triglycerides (≥200 mg/dL) before treatment begins. The protocol includes clinic visits, metabolic assessments and optional MRI to track body composition, caloric intake changes, glycemic control, triglycerides and safety. The study is conducted at a single site (University of Michigan, Ann Arbor) and focuses on metabolic outcomes and tolerability.
Who should consider this trial
Good fit: Adults (≥18 years) with a diagnosis of familial partial lipodystrophy who have HbA1c ≥7.0% and triglycerides ≥200 mg/dL after a 12-week run-in, with stable weight and diet and ability to attend clinic visits are ideal candidates.
Not a fit: Patients with generalized or acquired lipodystrophy, those who have previously received GLP‑1 agonist therapy, or those with recent major weight or diet changes are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, tirzepatide could improve blood sugar control and lower triglycerides in people with familial partial lipodystrophy, potentially reducing metabolic complications.
How similar studies have performed: Tirzepatide has shown large improvements in glucose control and weight loss in diabetes and obesity trials, but its application to partial lipodystrophy is novel and unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Ann Arbor, Michigan
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Elif Oral, MD — University of Michigan
- Study coordinator: Adam Neidert, MS
- Email: aneidert@med.umich.edu
- Phone: 734-615-0539
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.