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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
457
Administered as subcutaneous (SC) injection
Tablets administered orally
Administered as SC injection
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
Fibrosis improvement was defined as ≥ 1-stage decrease from baseline in fibrosis according to the NASH clinical research network (CRN) classification. Worsening of NASH was defined as ≥ 1-point increase from baseline in hepatocellular ballooning or lobular inflammation. Clopper-Pearson method was used in outcome measure analysis in each arm. Percentages were rounded-off.
Time frame: Week 72
Percentage of Participants Who Achieved ≥1-Stage Improvement in Fibrosis Without Worsening of NASH at Week 72 in SEMA + CILO/FIR FDC Versus SEMA Alone
Fibrosis improvement was defined as ≥ 1-stage decrease from baseline in fibrosis according to the NASH CRN classification. Worsening of NASH was defined as ≥ 1-point increase from baseline in hepatocellular ballooning or lobular inflammation. Clopper-Pearson method was used in outcome measure analysis in each arm. Percentages were rounded-off.
Time frame: Week 72
Percentage of Participants With NASH Resolution Without Worsening in Fibrosis at Week 72 in SEMA + CILO/FIR FDC Versus Placebo Groups
NASH resolution is defined as lobular inflammation of 0 or 1 and hepatocellular ballooning of 0. Worsening in fibrosis was defined as a change in fibrosis worsening stage as per NASH CRN criteria. Clopper-Pearson method was used in outcome measure analysis in each arm. Percentages were rounded-off.
Time frame: Week 72
Percentage of Participants With NASH Resolution Without Worsening in Fibrosis In Participants Treated With SEMA + CILO/FIR FDC Versus CILO/FIR Alone Groups
NASH resolution is defined as lobular inflammation of 0 or 1 and hepatocellular ballooning of 0. Worsening in fibrosis was defined as a change in fibrosis worsening stage as per NASH CRN criteria. Clopper-Pearson method was used in outcome measure analysis in each arm. Percentages were rounded-off.
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Tablets administered orally
University of Alabama at Birmingham Hospital
Birmingham, Alabama, United States
Digestive Health Specialists
Dothan, Alabama, United States
North Alabama Health Research, LLC
Madison, Alabama, United States
The Institution For Liver Health dba Arizona Liver Health
Chandler, Arizona, United States
Arizona Health Research
Chandler, Arizona, United States
The Institute for Liver Health DBA Arizona Liver Health
Peoria, Arizona, United States
Gastrointestinal Alliance - Sun City
Sun City, Arizona, United States
Adobe Clinical Research, LLC
Tucson, Arizona, United States
The Institution For Liver Health dba Arizona Liver Health
Tucson, Arizona, United States
Arkansas Diagnostic Center
Little Rock, Arkansas, United States
...and 232 more locations
Time frame: Week 72