Recent Updates
Recently added Catalysts

LY3849891

Phase 1

Metabolic Dysfunction-Associated Steatohepatitis (MASH) | Small molecule | Metabolic |Eli Lilly and Company|Trials Updated: Jun 24, 2026

LY3849891 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since May 2022

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment115

FDA Designations

No designations recorded

LY3849891 clinical trials

LY3849891 · 1 trial · 2 indications

Phase 1 1
NCT05395481A Single-Ascending and Repeated Dose Study of LY3849891 in Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)Metabolic Dysfunction-Associated Steatohepatitis (MASH)
COMPLETED115 Analytics
PHASE1COMPLETED
A Single-Ascending and Repeated Dose Study of LY3849891 in Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatohepatitis (MASH)Unlock trial analytics

Study Endpoints

Primary Endpoints

Part A: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Adverse Event(s) (AEs) Considered by the Investigator to be Related to Study Drug Administration
Predose up to 26 weeks post dose

A summary of TEAEs and AEs, regardless of causality, will be reported in the Reported Adverse Events module

Part B: Pharmacodynamics (PD): Mean change from baseline on liver inflammation and fibrosis measured by magnetic resonance imaging (MRI)
Baseline through 24 weeks

PD: Mean change from baseline on liver inflammation and fibrosis content measured by MRI

Secondary Endpoints

Part A: PD: Liver fat content measured by magnetic resonance imaging proton density fat fraction (MRI-PDFF)
Predose through Week 26
Part A: PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC(0-inf)) of LY3849891
Predose through Week 26
Part A: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3849891
Predose through Week 26
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
LY3849891 (Part A)EXPERIMENTALSingle ascending doses of LY3849891 administered subcutaneously (SC)
LY3849891 (Part B)EXPERIMENTALRepeated doses of LY3849891 administered SC
Placebo (Part A)PLACEBO_COMPARATORPlacebo administered SC
Placebo (Part B)PLACEBO_COMPARATORPlacebo administered SC

Interventions

NameTypeDescription
LY3849891DRUGAdministered SC
PlaceboDRUGAdministered SC
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites16

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 * Participan...

Countries:United StatesJapanPuerto Rico
Unlock Eligibility Criteria

Recent Changes (Last 90 Days)

MEDIUMJul 25, 2026NCT05395481TRIAL_REMOVED: changed
MEDIUMJul 25, 2026NCT05395481TRIAL_REMOVED: changed
MEDIUMJul 25, 2026NCT05395481TRIAL_REMOVED: changed
MEDIUMJul 25, 2026NCT05395481TRIAL_REMOVED: changed

Frequently asked questions about LY3849891

What is LY3849891?

LY3849891 is an investigational small molecule developed by Eli Lilly and Company for metabolic dysfunction-associated steatohepatitis (MASH), a progressive liver disease. It is in Phase 1 clinical development and has been studied in a single completed trial. It is not an approved medicine.

What is LY3849891 used for in MASH?

LY3849891 is being developed to treat metabolic dysfunction-associated steatohepatitis (MASH), also referred to as metabolic dysfunction-associated steatotic liver disease (MASLD). The Phase 1 program enrolled participants with these liver conditions rather than healthy volunteers, and the study has been completed.

Who makes LY3849891?

LY3849891 is developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly sponsored the Phase 1 clinical study of the compound in participants with metabolic dysfunction-associated steatotic liver disease.

What phase is LY3849891 in?

LY3849891 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. Because it remains investigational, LY3849891 has not been approved by the FDA for any indication.

What clinical trials is LY3849891 in?

LY3849891 has been evaluated in one Phase 1 trial, NCT05395481, titled a single-ascending and repeated dose study in participants with metabolic dysfunction-associated steatotic liver disease. The trial enrolled 115 participants across the United States, Japan, and Puerto Rico and is now completed.

How was the LY3849891 Phase 1 trial designed?

The Phase 1 trial NCT05395481 was a randomized, double-blind, placebo-controlled study of single-ascending and repeated doses of LY3849891 in adults with metabolic dysfunction-associated steatotic liver disease. It enrolled 115 participants aged 18 years and older, including both sexes, and used a biomarker-selected population.