Trials / Active Not Recruiting
Active Not RecruitingNCT05395481
A Single-Ascending and Repeated Dose Study of LY3849891 in Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
A Single-Ascending and Repeated Subcutaneous Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3849891 in Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) Who Have the PNPLA3 I148M Genotype
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 176 (estimated)
- Sponsor
- Eli Lilly and Company · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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
- Metabolic Dysfunction-Associated Steatohepatitis (MASH)
- Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | LY3849891 | Administered SC |
| DRUG | Placebo | Administered SC |
Timeline
- Start date
- 2022-06-08
- Primary completion
- 2026-05-01
- Completion
- 2026-05-01
- First posted
- 2022-05-27
- Last updated
- 2026-01-22
Locations
16 sites across 3 countries: United States, Japan, Puerto Rico
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05395481. Inclusion in this directory is not an endorsement.