drugset / Trial / NCT04971785
Study of Semaglutide, and Cilofexor/Firsocostat, Alone and in Combination, in Adults With Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)
RandomizedParallel-groupDouble-blindTreatment
Summary
The goal of this clinical study is to understand whether the study drugs, semaglutide (SEMA) with the fixed-dose combination (FDC) of cilofexor/firsocostat (CILO/FIR), cause fibrosis improvement and Nonalcoholic Steatohepatitis (NASH) resolution in participants with cirrhosis due to NASH.
Timeline
- Start
- 2021-08-09
- Primary completion
- 2024-11-12
- Completion
- 2024-12-09
Outcome
Missed primary endpoint
registry analysis (superiority test); SEMA + CILO/FIR FDC vs PTM SEMA + PTM CILO/FIR; p = 0.2289; Difference in percentages 5.7 (95% CI -3.6 to 14.9) NCT04971785 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cilofexor | Small molecule | 30 mg | Oral |
| Subject | Firsocostat | Small molecule | 20 mg | Oral |
| Subject | Semaglutide | Peptide | 3 mg/ml | Subcutaneous |