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A Single-Ascending and Repeated Dose Study of LY3849891 in Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Sponsor: Eli Lilly and Company
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
176
Start Date
2022-06-08
Completion Date
2026-05
Last Updated
2026-01-22
Healthy Volunteers
No
Conditions
Interventions
LY3849891
Administered SC
Placebo
Administered SC
Locations (16)
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