Study to Evaluate the Safety and Efficacy of Selonsertib, Firsocostat, Cilofexor, and Combinations in Participants With Bridging Fibrosis or Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)
Purpose
The primary objectives of this study are: - To assess the safety and tolerability of selonsertib (SEL), firsocostat (FIR) and cilofexor (CILO), administered alone or in combination, in participants with bridging fibrosis or compensated cirrhosis due to NASH - To evaluate changes in liver fibrosis, without worsening of NASH
Condition
- Nonalcoholic Steatohepatitis
Eligibility
- Eligible Ages
- Between 18 Years and 80 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Liver biopsy consistent with NASH and F3 or F4 in the opinion of the central reader - In participants who have never had a liver biopsy, liver stiffness by FibroScan® ≥ 14.0 kPa and Enhanced Liver Fibrosis (ELF™) Test score ≥ 9.8 at Screening - Screening laboratory parameters, as determined by the central laboratory: - Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min, as calculated by the Cockcroft-Gault equation - Hemoglobin A1c (HbA1c) ≤ 9.5% - Alanine aminotransferase (ALT) < 5 x Upper Limits of Normal (ULN) - Platelet count ≥ 125,000/μL
Exclusion Criteria
- Prior history of decompensated liver disease including ascites, hepatic encephalopathy, 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 alternate etiology such as therapeutic anticoagulation - Other causes of liver disease based on medical history and/or centralized review of liver histology, including but not limited to: alcoholic liver disease, hepatitis B, hepatitis C, autoimmune disorders (eg, primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis), drug-induced hepatotoxicity, Wilson disease, clinically significant iron overload, or alpha-1-antitrypsin deficiency requiring treatment - History of liver transplantation - Current or prior history of hepatocellular carcinoma Note: Other protocol defined Inclusion/ Exclusion criteria may apply
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Selonsertib (SEL) |
Participants will receive SEL + placebo to match firsocostat 20 mg tablet + placebo to match cilofexor 30 mg tablet orally once daily for 48 weeks. |
|
Experimental Firsocostat (FIR) |
Participants will receive placebo to match SEL 18 mg tablet + FIR + placebo to match CILO 30 mg tablet orally once daily for 48 weeks. |
|
Experimental Cilofexor (CILO) |
Participants will receive placebo to match SEL 18 mg tablet + placebo to match FIR 20 mg tablet + CILO orally once daily for 48 weeks. |
|
Experimental Selonsertib (SEL) + Firsocostat (FIR) |
Participants will receive SEL + FIR + placebo to match CILO 30 mg tablet orally once daily for 48 weeks. |
|
Experimental Selonsertib (SEL) + Cilofexor (CILO) |
Participants will receive SEL + placebo to match FIR 20 mg tablet + CILO orally once daily for 48 weeks. |
|
Experimental Firsocostat (FIR) + Cilofexor (CILO) |
Participants will receive placebo to match SEL 18 mg tablet + FIR + CILO orally once daily for 48 weeks. |
|
Experimental Placebo |
Participants will receive placebo to match SEL 18 mg + placebo to match FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks. |
|
More Details
- Status
- Completed
- Sponsor
- Gilead Sciences