A Single-Ascending and Repeated Dose Study of LY3849891 in Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Completed · Phase 1 · Has a placebo group
Conditions studied: Metabolic Dysfunction-Associated Steatohepatitis (MASH), Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)
In brief
The main purpose of this study is to evaluate the safety and tolerability of the study drug LY3849891 in participants with metabolic dysfunction-associated steatotic liver disease (MASLD) who have the patatin-like phospholipase domain-containing protein 3 (PNPLA3) I148M genotype. Blood tests and magnetic resonance imaging of the liver will be performed to determine the effects of LY3849891 on MASLD and assessment of resolution of liver fibroinflammation. Blood tests will also determine how long it takes the body to eliminate LY3849891. This is a 2-part study and may last up to 32 weeks for each participant and may include 12 visits in parts A and B.
Key facts
- Study ID
- NCT05395481
- Run by
- Eli Lilly and Company
- People needed
- 115
- Starts
- 2022-06-08
- Expected to finish
- 2026-05-12
- Last updated by the study team
- 2026-06-24
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 it is running
- Arizona Liver Health - Chandler — Chandler, Arizona, United States
- Orange County Research Center — Orange, California, United States
- Inland Empire Clinical Trials, LLC — Rialto, California, United States
- Synergy Healthcare LLC — Brandon, Florida, United States
- Accel Research Sites - Maitland — Maitland, Florida, United States
- Evolution Clinical Trials, Inc — Miami, Florida, United States
- Advanced Pharma Clinical Research — Miami, Florida, United States
- Floridian Clinical Research — Miami Lakes, Florida, United States
- Charter Research - Winter Park — Orlando, Florida, United States
- IU Health University Hospital — Indianapolis, Indiana, United States
- Houston Research Institute — Houston, Texas, United States
- Clinical Trials of Texas, Inc. — San Antonio, Texas, United States
- Pinnacle Clinical Research — San Antonio, Texas, United States
- P-One Clinic — Hachiōji, Japan
- Clinical Research Hospital Tokyo — Shinjuku-ku, Japan
- FDI Clinical Research — San Juan, Puerto Rico
Full record on ClinicalTrials.gov
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