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

NCT04971785 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 457

Last updated 2025-11-26

Study results available
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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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-09
Primary Completion
2024-11-12
Completion
2024-12-09
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • France
  • Japan
  • Puerto Rico
  • Spain

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04971785 on ClinicalTrials.gov