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

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

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

NCT05395481•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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion 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)
•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 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

Exclusion Criteria

•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

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

Key Dates

Start Date

June 8, 2022

Primary Completion Date

May 1, 2026

Completion Date

May 1, 2026

Last Updated

January 22, 2026

Enrollment

176

ESTIMATED participants

Conditions

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

Interventions

LY3849891

DRUG

Placebo

DRUG

A Multi-country, Cross-sectional Quantitative Study Exploring Awareness, Understanding, and Perceptions of the Relation Between Cardiorenal Metabolic Conditions and MASLD/MASH Among Healthcare Providers, People With MASLD/MASH, and At-risk Population

NCT07201831

Metabolic Dysfunction-associated Steatohepatitis (MASH)

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NOT_YET_RECRUITINGNA

Assessment of Gut Microbiota-Derived Amino Acid Metabolite Production in Patients With MASLD

NCT07313007

MASLD - Metabolic Dysfunction-Associated Steatotic Liver DiseaseMetabolic Dysfunction-Associated Steatohepatitis (MASH)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 22, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Multi-country, Cross-sectional Quantitative Study Exploring Awareness, Understanding, and Perceptions of the Relation Between Cardiorenal Metabolic Conditions and MASLD/MASH Among Healthcare Providers, People With MASLD/MASH, and At-risk Population

Assessment of Gut Microbiota-Derived Amino Acid Metabolite Production in Patients With MASLD

New Non-invasive Biomarkers of Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)