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

Last updated: May 20, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

1

Condition

Primary Biliary Cholangitis

Liver Disease

Treatment

Placebo

LY3849891

Clinical Study ID

NCT05395481
18214
J3W-MC-GZOA
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants must have a body mass index (BMI) within the range greater than orequal 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 asdetermined 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 durationof 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, ortubal ligation), congenital anomaly such as Mullerian agenesis; or those who arepostmenopausal

Exclusion

Exclusion Criteria:

  • Participants must not have known or suspected alcohol abuse (>14 units/week forwomen 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 congestiveheart 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 filtrationrate (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 personswith cardiac pacemaker and implants made out of metal (for example, cochlearimplant, nerve stimulators, magnetic vascular clips, and metallic heart valve) orother contraindications for MRI

Study Design

Total Participants: 176
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
June 08, 2022
Estimated Completion Date:
October 31, 2026

Connect with a study center

  • P-One Clinic

    Hachioji, Tokyo 192-0071
    Japan

    Active - Recruiting

  • Clinical Research Hospital Tokyo

    Shinjuku-ku, Tokyo 160-0004
    Japan

    Active - Recruiting

  • FDI Clinical Research

    San Juan, 00927
    Puerto Rico

    Site Not Available

  • Arizona Liver Health - Chandler

    Chandler, Arizona 85225
    United States

    Site Not Available

  • Orange County Research Center

    Orange, California 92868
    United States

    Active - Recruiting

  • Inland Empire Clinical Trials, LLC

    Rialto, California 92377
    United States

    Site Not Available

  • Orange County Research Center

    Tustin, California 92780
    United States

    Site Not Available

  • Synergy Healthcare LLC

    Brandon, Florida 33511
    United States

    Site Not Available

  • Accel Research Sites - Maitland

    Maitland, Florida 32751
    United States

    Active - Recruiting

  • Advanced Pharma Clinical Research

    Miami, Florida 33175
    United States

    Active - Recruiting

  • Evolution Clinical Trials, Inc

    Miami, Florida 33122
    United States

    Site Not Available

  • Floridian Clinical Research

    Miami, Florida 33016
    United States

    Active - Recruiting

  • Charter Research - Winter Park

    Orlando, Florida 32803
    United States

    Site Not Available

  • IU Health University Hospital

    Indianapolis, Indiana 46290
    United States

    Active - Recruiting

  • Houston Research Institute

    Houston, Texas 77079
    United States

    Site Not Available

  • Clinical Trials of Texas, Inc.

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Pinnacle Clinical Research

    San Antonio, Texas 78229
    United States

    Active - Recruiting

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