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

NCT04971785 · Completed

Last updated 2026-05-28

This clinical trial is testing whether the medications semaglutide, cilofexor, and firsocostat—alone or combined—can improve liver scarring in adults with cirrhosis caused by nonalcoholic steatohepatitis (NASH).

Status Completed The study has finished.

Phase Phase 2 Tests whether it works and watches safety in a moderate group.

Type Interventional (clinical trial)

Design Randomized, double-blind treatment study

Participants 457 people

Who can join Ages 18–80 · all sexes

Timeline Started 2021-08 · est. completion 2024-12

Where 242 sites · Australia, Canada, France, Japan, Puerto Rico, Spain, United States

What this study is testing ClinicalTrials.gov NCT04971785 ↗

Description as written by the study sponsor.

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.

Treatments tested

Semaglutide (SEMA) Drug

Administered as subcutaneous (SC) injection
Cilofexor (CILO)/Firsocostat (FIR) also known as GS-9674/GS-0976 Drug

Tablets administered orally
PTM SEMA Drug

Administered as SC injection
PTM CILO/FIR Drug

Tablets administered orally

Main thing measured	Percentage of Participants Who Achieved ≥ 1-Stage Improvement in Fibrosis Without Worsening of Nonalcoholic Steatohepatitis (NASH) at Week 72 in Semaglutide (SEMA) + Cilofexor/Firsocostat (CILO/FIR) Fixed Dose Combination (FDC) Versus Placebo Groups
Sponsor	Gilead Sciences
Conditions studied	Nonalcoholic Steatohepatitis
GLP-1 drugs	semaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT04971785 ↗