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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: Active Phase 1 study of Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), sponsored by Eli Lilly and Company.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
A summary of TEAEs and AEs, regardless of causality, will be reported in the Reported Adverse Events module
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 |
What the registry record for NCT05395481 still lists
NCT05395481 is an interventional study that assigns participants to a tested intervention. The registered 176 participants enrollment target is mid-sized for trials with a published cap, below the 439-participant average among 5 other Metabolic Dysfunction-Associated Steatohepatitis (MASH) trials with a reported enrollment target (60% lower).
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 lists 16 locations in 6 states (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.
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