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ACTIVE NOT RECRUITING
NCT05395481
PHASE1

A Single-Ascending and Repeated Dose Study of LY3849891 in Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

Sponsor: Eli Lilly and Company

View on ClinicalTrials.gov

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

Interventions

DRUG

LY3849891

Administered SC

DRUG

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