Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05395481 · ClinicalTrials.gov registry record · Phase 1
A Single-Ascending and Repeated Dose Study of LY3849891 in Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
A Phase 1 study of Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), sponsored by Eli Lilly and Company.
- Active
- Registry status
- Phase 1
- Development phase
- 176
- Enrollment target
- 16
- Study locations
NCT05395481 is a Phase 1 study of Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) that is active but no longer recruiting, run by Eli Lilly and Company. The registered enrollment target is 176 participants, below the 439-participant average among 5 other Metabolic Dysfunction-Associated Steatohepatitis (MASH) trials with a reported enrollment target (60% lower). The trial reports 16 study locations across 6 states.
The verdict
NCT05395481, a Phase 1 study of Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), is active but no longer recruiting, sponsored by Eli Lilly and Company.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 176 participants
- Enrollment target
- 16
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG LY3849891
Study Locations (16)
Florida
- Synergy Healthcare LLC - Brandon
- Accel Research Sites - Maitland - Maitland
- Evolution Clinical Trials, Inc - Miami
- Advanced Pharma Clinical Research - Miami
- Floridian Clinical Research - Miami Lakes
- Charter Research - Winter Park - Orlando
Texas
- Houston Research Institute - Houston
- Clinical Trials of Texas, Inc. - San Antonio
- Pinnacle Clinical Research - San Antonio
Other
- P-One Clinic - Hachiōji
- Clinical Research Hospital Tokyo - Shinjuku-ku
- FDI Clinical Research - San Juan
California
- Orange County Research Center - Orange
- Inland Empire Clinical Trials, LLC - Rialto
Arizona
- Arizona Liver Health - Chandler - Chandler
Indiana
- IU Health University Hospital - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 176 participants |
| Start Date | 2022-06-08 |
| Est. Completion | 2026-05 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05395481
The ClinicalTrials.gov registry entry for NCT05395481 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 176 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 439-participant average among 5 other Metabolic Dysfunction-Associated Steatohepatitis (MASH) trials with a reported enrollment target (60% lower). The listed sponsor is Eli Lilly and Company, which has 1,341 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Metabolic Dysfunction-Associated Steatohepatitis (MASH) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05395481 reports 16 study locations spanning 6 distinct geographic areas - top geographies include Florida, Texas, Other.
Frequently Asked Questions
What is clinical trial NCT05395481 about?
NCT05395481 is a clinical study titled "A Single-Ascending and Repeated Dose Study of LY3849891 in Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)". 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 mag...
What is the current status of trial NCT05395481?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 176 participants. The study started on 2022-06-08. Estimated completion is 2026-05.
What conditions does trial NCT05395481 study?
This clinical trial studies the following conditions: Metabolic Dysfunction-Associated Steatohepatitis (MASH), Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD).
What interventions are being tested in trial NCT05395481?
The interventions under investigation include: Placebo (DRUG), LY3849891 (DRUG).
Who is sponsoring clinical trial NCT05395481?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05395481 being conducted?
This trial has 16 study locations across Arizona, California, Florida, Indiana, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Evaluation of Miricorilant on Liver Fat in Patients With MASLD
RECRUITING · Phase 1
-
Fibrosis Lessens After Metabolic Surgery
RECRUITING · Phase 4
-
A Precision Medicine Approach Using Gene Silencing to Treat a Chronic Liver Disease Called Metabolic Dysfunction-Associated Steatohepatitis (MASH) in Adult Participants at Increased Genetic Risk for This Condition
RECRUITING · Phase 2
-
LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis
RECRUITING · Phase 3
-
A Phase 2b, Study Evaluating Miricorilant in Adult Patients With Nonalcoholic Steatohepatitis/Metabolic Dysfunction-Associated Steatohepatitis (MONARCH)
ACTIVE NOT RECRUITING · Phase 2
Explore more on PlainTrial
Metabolic Dysfunction-Associated Steatohepatitis (MASH)
All registered trials for this condition
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
All registered trials for this condition
Arizona
All trials with a study site in Arizona
Recruiting now
Find trials open to new participants near you
Rankings
Top sponsors, conditions, and phases
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.