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LY3849891

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment115

FDA Designations

No designations recorded

Clinical trial landscape

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
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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
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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
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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
HIGHJun 24, 2026NCT05395481Status: ACTIVE_NOT_RECRUITING → COMPLETED
HIGHJun 24, 2026NCT05395481Status: ACTIVE_NOT_RECRUITING → COMPLETED

Frequently asked questions about LY3849891

What is LY3849891 used for?

LY3849891 is an investigational small molecule being developed for Metabolic Dysfunction-Associated Steatohepatitis (MASH), a form of fatty liver disease. It is also being studied in patients with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). The drug is in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes LY3849891?

LY3849891 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The company is conducting clinical trials to evaluate the safety and tolerability of this investigational drug in patients with metabolic liver diseases.

What phase is LY3849891 in?

LY3849891 is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational. It has not been approved by the FDA or any other regulatory agency, and its safety and efficacy have not been established.

What clinical trials is LY3849891 in?

LY3849891 has one completed clinical trial, registered as NCT05395481. This was a Phase 1, single-ascending and repeated dose study in participants with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). The trial enrolled 115 participants and was conducted in the United States, Japan, and Puerto Rico.

Is LY3849891 a small molecule?

Yes, LY3849891 is a small molecule therapeutic. It is being developed as an oral treatment for Metabolic Dysfunction-Associated Steatohepatitis (MASH) and related fatty liver conditions. The drug is currently in early-stage clinical testing.