Evaluating LY3849891 for liver disease related to metabolic dysfunction
A Single-Ascending and Repeated Subcutaneous Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3849891 in Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) Who Have the PNPLA3 I148M Genotype
This study is testing a new drug called LY3849891 to see if it is safe and helps people with a specific type of liver disease related to metabolic issues.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 176 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Locations | 16 sites (Chandler, Arizona and 15 other locations) |
| Trial ID | NCT05395481 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and tolerability of the drug LY3849891 in individuals with metabolic dysfunction-associated steatotic liver disease (MASLD) who carry the PNPLA3 I148M genotype. Participants will undergo blood tests and magnetic resonance imaging (MRI) to evaluate the drug's effects on liver fat and fibrosis. The study consists of two parts and may last up to 32 weeks, involving up to 12 visits for each participant. The research will also measure how long it takes for the body to eliminate the drug.
Who should consider this trial
Good fit: Ideal candidates include adults with a BMI between 25 and 50, liver fat content above 10%, and carriers of the PNPLA3 I148M allele.
Not a fit: Patients with known or suspected alcohol abuse will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients suffering from MASLD, potentially improving liver health and reducing complications.
How similar studies have performed: Other studies have explored treatments for MASLD, but the specific approach of using LY3849891 in this genetic context is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants must have a body mass index (BMI) within the range greater than or equal to (≥) 25 and less than (\<) 50 kilogram per square meter (kg/m²) inclusive * Participants must have liver fat content ≥10% in Part A and ≥8% for Part B as determined by MRI-PDFF * Participants must be carriers of the PNPLA3 I148M allele * Participants with or without type 2 diabetes mellitus (T2DM) o For participants with T2DM, hemoglobin A1c (HbA1c) \<8% in Part A and \<9% in Part B * Male participants agree to use an effective method of contraception for the duration of the study and for 90 days after the last dose of study intervention * Women not of childbearing potential may participate and include those who are: infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation), congenital anomaly such as Mullerian agenesis; or those who are postmenopausal Exclusion Criteria: * Participants must not have known or suspected alcohol abuse (\>14 units/week for women and \>21 units/week for men) or active substance abuse * Participants must not have evidence of cirrhosis or other forms of liver disease * Participants must not have heart attack, stroke, or hospitalization for congestive heart failure in the past 3 months * Participants must not have active cancer within the last 5 years * Participants must not have uncontrolled high blood pressure * Participants must not have renal impairment with estimated glomerular filtration rate (eGFR) \<60 milliliter per minute per 1.73 square meter (ml/min/1.73m²) * Participants must not have a diagnosis of type 1 diabetes * Participants must not have a contraindication to MRI examinations, such as persons with cardiac pacemaker and implants made out of metal (for example, cochlear implant, nerve stimulators, magnetic vascular clips, and metallic heart valve) or other contraindications for MRI
Where this trial is running
Chandler, Arizona and 15 other locations
- Arizona Liver Health - Chandler — Chandler, Arizona, United States (Not_yet_recruiting)
- Orange County Research Center — Orange, California, United States (Recruiting)
- Inland Empire Clinical Trials, LLC — Rialto, California, United States (Not_yet_recruiting)
- Synergy Healthcare LLC — Brandon, Florida, United States (Not_yet_recruiting)
- Accel Research Sites - Maitland — Maitland, Florida, United States (Recruiting)
- Floridian Clinical Research — Miami, Florida, United States (Recruiting)
- Evolution Clinical Trials, Inc — Miami, Florida, United States (Not_yet_recruiting)
- Advanced Pharma Clinical Research — Miami, Florida, United States (Recruiting)
- Charter Research - Winter Park — Orlando, Florida, United States (Not_yet_recruiting)
- IU Health University Hospital — Indianapolis, Indiana, United States (Recruiting)
- Houston Research Institute — Houston, Texas, United States (Not_yet_recruiting)
- Clinical Trials of Texas, Inc. — San Antonio, Texas, United States (Recruiting)
- Pinnacle Clinical Research — San Antonio, Texas, United States (Recruiting)
- P-One Clinic — Hachioji, Tokyo, Japan (Recruiting)
- Clinical Research Hospital Tokyo — Shinjuku-ku, Tokyo, Japan (Recruiting)
- FDI Clinical Research — San Juan, Puerto Rico (Not_yet_recruiting)
Study contacts
- Study coordinator: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
- Email: clinical_inquiry_hub@lilly.com
- Phone: 1-317-615-4559
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.