drugset / Trial / NCT05402371
A Study to Evaluate the Efficacy and Safety of Rencofilstat in Subjects With NASH and Advanced Liver Fibrosis
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a randomized, double-blind, placebo-controlled, parallel-dosing, multi-center study to evaluate the efficacy and safety of Rencofilstat as evidenced by histopathological improvements in fibrosis in adult NASH subjects with F2 or F3 fibrosis (NASH CRN system). Antifibrotic biomarker activity will be evaluated on an exploratory basis.
Timeline
- Start
- 2022-10-15
- Primary completion
- 2025-05
- Completion
- 2025-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | rencofilstat | Small molecule | 75 mg | — |
| Subject | rencofilstat | Small molecule | 150 mg | — |
| Subject | rencofilstat | Small molecule | 225 mg | — |