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

Description

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.

Conditions

Metabolic Dysfunction-Associated Steatohepatitis (MASH), Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Intervention / Treatment

-

Contacts and Locations

Chandler

Arizona Liver Health - Chandler, Chandler, Arizona, United States, 85225

Orange

Orange County Research Center, Orange, California, United States, 92868

Rialto

Inland Empire Clinical Trials, LLC, Rialto, California, United States, 92377

Brandon

Synergy Healthcare LLC, Brandon, Florida, United States, 33511

Maitland

Accel Research Sites - Maitland, Maitland, Florida, United States, 32751

Miami

Floridian Clinical Research, Miami, Florida, United States, 33016

Miami

Evolution Clinical Trials, Inc, Miami, Florida, United States, 33122

Miami

Advanced Pharma Clinical Research, Miami, Florida, United States, 33175

Orlando

Charter Research - Winter Park, Orlando, Florida, United States, 32803

Indianapolis

IU Health University Hospital, Indianapolis, Indiana, United States, 46290

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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)
  • * 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
  • * 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

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Eli Lilly and Company,

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

2026-10