NCT04971785

Study of Semaglutide, and Cilofexor/Firsocostat, Alone and in Combination, in Adults With Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)

A Phase 2, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Study Evaluating the Safety and Efficacy of Semaglutide, and the Fixed-Dose Combination of Cilofexor and Firsocostat, Alone and in Combination, in Subjects With Compensated Cirrhosis (F4) Due to Nonalcoholic Steatohepatitis (NASH)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 457 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nonalcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	Semaglutide (SEMA)	Administered as subcutaneous (SC) injection
DRUG	Cilofexor (CILO)/Firsocostat (FIR)	Tablets administered orally
DRUG	PTM SEMA	Administered as SC injection
DRUG	PTM CILO/FIR	Tablets administered orally

Timeline

• Start date: 2021-08-09
• Primary completion: 2024-11-12
• Completion: 2024-12-09
• First posted: 2021-07-21
• Last updated: 2025-11-26
• Results posted: 2025-11-26

Locations

242 sites across 7 countries: United States, Australia, Canada, France, Japan, Puerto Rico, Spain

Regulatory

• FDA-regulated drug study