A Single-Ascending and Repeated Dose Study of LY3849891 in Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
NCT ID: NCT05395481
Last Updated: 2026-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
176 participants
INTERVENTIONAL
2022-06-08
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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LY3849891 (Part A)
Single ascending doses of LY3849891 administered subcutaneously (SC)
LY3849891
Administered SC
LY3849891 (Part B)
Repeated doses of LY3849891 administered SC
LY3849891
Administered SC
Placebo (Part A)
Placebo administered SC
Placebo
Administered SC
Placebo (Part B)
Placebo administered SC
Placebo
Administered SC
Interventions
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LY3849891
Administered SC
Placebo
Administered SC
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
70 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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
Houston Research Institute
Houston, Texas, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
Pinnacle Clinical Research
San Antonio, Texas, United States
P-One Clinic
Hachiōji, , Japan
Clinical Research Hospital Tokyo
Shinjuku-ku, , Japan
FDI Clinical Research
San Juan, , Puerto Rico
Countries
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Related Links
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A Single-Ascending and Repeated Dose Study of LY3849891 in Participants With Nonalcoholic Fatty Liver Disease
Other Identifiers
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J3W-MC-GZOA
Identifier Type: OTHER
Identifier Source: secondary_id
18214
Identifier Type: -
Identifier Source: org_study_id
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