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)

Gilead Sciences, Inc.0 sites440 target enrollmentOctober 8, 2021

Overview

No summary available.

Registry

who.int

Start Date

October 8, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\)Men and women between 18 and 80 years of age, inclusive, based on the date of the screening visit
•2\)Willing and able to give informed consent prior to any study\-specific procedures being performed
•3\)Cirrhosis (F4\) due to NASH as defined in the protocol
•4\)The following laboratory parameters at screening, as determined by the central laboratory:
•a)Estimated glomerular filtration rate (eGFR) \= 30 mL/min/1\.73m2, as calculated by the Modification of Diet in Renal Disease (MDRD) equation to estimate creatinine clearance (CLcr)
•b)HbA1c \= 10% (or serum fructosamine \= 400 umol/L if HbA1c is not quantifiable)
•c)Hemoglobin \> 10\.6 g/dL
•d)INR \= 1\.4, unless due to therapeutic anticoagulation
•e)Total bilirubin \= 1\.3 x ULN (unless due to an alternative etiology such as Gilbert’s syndrome or hemolytic anemia)
•f)Serum albumin \= 3\.5 g/dL

•1\)Any history of decompensated liver disease in the opinion of the investigator, including clinically relevant ascites, hepatic encephalopathy (HE), or variceal bleeding
•2\)Child\-Pugh (CP) score \> 6 at screening, unless due to an alternative etiology such as Gilbert’s syndrome or therapeutic anticoagulation
•3\)Model for End\-stage Liver Disease (MELD) score \>12 at screening, unless due to an alternative etiology such as therapeutic anticoagulation
•4\)Chronic HBV infection (HBsAg positive)
•5\)Chronic HCV infection (HCV antibody and HCV RNA positive). Subjects cured of HCV infection less than 2 years prior to the screening visit are not eligible.
•6\)Other causes of liver disease based on medical history and/or central pathologist review of liver histology, including but not limited to: alcoholic liver disease, autoimmune disorders (eg, PBC, PSC, autoimmune hepatitis), drug\-induced hepatotoxicity, Wilson disease, clinically significant iron overload, or alpha\-1\-antitrypsin deficiency
•7\)History of liver transplantation
•8\)Current or prior history of HCC
•9\)HIV infection
•10\)Weight loss \>10% within 180 days of screening, or \>5% between the date of the biopsy used for eligibility and the date of screening