Study of Semaglutide, and Cilofexor/Firsocostat, Alone and in Combination, in Adults With Cirrhos… (NCT04971785) | Clinical Trial Compass
CompletedPhase 2
Study of Semaglutide, and Cilofexor/Firsocostat, Alone and in Combination, in Adults With Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)
United States457 participantsStarted 2021-08-09
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Key Inclusion Criteria:
* Liver biopsy consistent with cirrhosis (F4) due to nonalcoholic steatohepatitis (NASH) in the opinion of the central reader. In individuals who have never had a liver biopsy, a screening liver biopsy may be performed.
* Screening laboratory parameters as determined by the study central laboratory:
* Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m\^2, as calculated by the Modification of Diet in Renal Disease (MDRD) equation.
* Hemoglobin A1c (HbA1c) ≤ 10%
* International normalized ratio (INR) ≤ 1.4, unless due to therapeutic anticoagulation
* Platelet count ≥ 125,000/µL
* Alanine aminotransferase (ALT) \< 5 x upper limit of normal (ULN)
* Serum albumin ≥ 3.5 g/dL
* Serum alkaline phosphatase (ALP) ≤ 2 x ULN
* Body mass index (BMI) ≥ 23 kg/m\^2 at screening.
Key Exclusion Criteria:
* Prior history of decompensated liver disease, including ascites, hepatic encephalopathy (HE), or variceal bleeding.
* Child-Pugh (CP) score \> 6 at screening, unless due to an alternative etiology such as Gilbert's syndrome or therapeutic anticoagulation.
* Model for End-stage Liver Disease (MELD) score \> 12 at screening, unless due to an alternative etiology such as therapeutic anticoagulation.
* Other causes of liver disease based on medical history and/or central reader review of liver histology, including but not limited to: alcoholic liver disease, autoimmune disorders (eg, primary biliary cholangitis, primary sclerosing cholangitis…
What they're measuring
1
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