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LY3849891

Phase 1

Metabolic Dysfunction-Associated Steatohepatitis (MASH) | Small molecule | Infectious Disease |Eli Lilly and Company|Last Updated: Jan 22, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment176
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05395481A Single-Ascending and Repeated Dose Study of LY3849891 in Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)PHASE1 ACTIVE NOT_RECRUITING 176Jun 8, 2022May 1, 2026Jan 22, 202616 United States, Japan +1
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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 — 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)
LOWMay 26, 2026NCT05395481primaryCompletionDate: changed
LOWMay 24, 2026NCT05395481studyFirstPostDate: changed