At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 457 enrolled
Drug / intervention
Semaglutide (SEMA) +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating Semaglutide (SEMA), Cilofexor (CILO)/Firsocostat (FIR), and 2 other interventions for Nonalcoholic Steatohepatitis. Completed, enrolled 457 participants across 242 sites in 7 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNonalcoholic Steatohepatitis
CountriesAustralia, Canada, France, Japan, Puerto Rico, Spain, United States
CollaboratorsNovo Nordisk A/S
Timeline
Phase 2CompletedFinished
20222023202420252026
First PostedJul 2021
Enrollment StartAug 2021
Primary CompletionNov 2024
Study CompletionDec 2024
TodayJul 2026
First PostedJul 21, 2021
Enrollment StartAug 9, 2021
Primary CompletionNov 12, 2024
Study CompletionDec 9, 2024
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 4.9 years ago
Interventions
Semaglutide (SEMA)drug
Administered as subcutaneous (SC) injection
Cilofexor (CILO)/Firsocostat (FIR)drug
Tablets administered orally
PTM SEMAdrug
Administered as SC injection
PTM CILO/FIRdrug
Tablets administered orally