Enrolling

A Single-Ascending and Repeated Dose Study of LY3849891 in Participants With Nonalcoholic Fatty Liver Disease

The main purpose of this study is to evaluate the safety and tolerability of the study drug LY3849891 in participants with nonalcoholic fatty liver disease 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 fatty liver disease. Blood tests will also determine how long it takes the body to eliminate LY3849891.

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See if You May Qualify

Answer a few questions to see if you meet key criteria for this study.

Trial Summary

Age Range
18 - 70 years
Conditions the trial is for
Non-Alcoholic Fatty Liver Disease
What the trial is testing?
LY3849891
Could I receive a Placebo?
Yes
Enrollment Goal
176
Trial Dates
Jun 8, 2022 - Nov 2024
How long will I be in the trial?
This is a 2-part study, your participation could last about 32 weeks and may include up to 13 visits (including part A and B) to the study center.
Trial Phase
I

Key Requirements

Clinical trials have inclusion and exclusion requirements to determine which individuals qualify for participation. Listed below are key requirements for this clinical trial, but there may be additional requirements to qualify.

Participants Must:

  • Participants must have a body mass index (BMI) ≥25 kilograms per square meter (kg/m²) and ≤50 kg/m²

  • Participants must have liver fat content ≥10% as determined by magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF)

  • Participants with or without type 2 diabetes mellitus (T2DM). If the participant has T2DM, the hemoglobin A1c (HbA1c)

  • Male participants must agree to use birth control during the study

  • Female participants must not be able to get pregnant

Participants Must Not:

  • 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 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 a diagnosis of type 1 diabetes

  • Participants must not have a history of inflammation of the pancreas

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