drugset / Trial / NCT06215716
A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with non-cirrhotic NASH/MASH and fibrosis stage 2 or 3 (F2 or F3). The study will enroll subjects in two cohorts for a total samples size of 1650 subjects.
Timeline
- Start
- 2023-12-01
- Primary completion
- 2033-02
- Completion
- 2033-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Efruxifermin | Protein / enzyme biologic | 28 mg | Subcutaneous |
| Subject | Efruxifermin | Protein / enzyme biologic | 50 mg | Subcutaneous |