Phase 2
N=395
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)
Nonalcoholic Steatohepatitis
Bottom Line
View on ClinicalTrials.gov: NCT03449446 ↗Enrolled (actual)
395
Serious AEs
11.5%
Results posted
Dec 2020
Primary outcome: Primary: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) — 84.6; 85.0; 92.5; 88.6 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SEL (Drug); FIR (Drug); CILO (Drug); Placebo to match FIR (Drug); Placebo to match CILO (Drug); Placebo to match SEL (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Gilead Sciences
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) |
84.6; 85.0; 92.5; 88.6; 96.1; 91.0 | — |
| PRIMARY Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities |
94.9; 100.0; 97.5; 98.7; 96.1; 100.0 | — |
| PRIMARY Percentage of Participants Who Achieved a ≥ 1-Stage Improvement in Fibrosis Without Worsening of NASH at Week 48 |
28.6; 12.1; 11.8; 15.5; 19.1; 20.9 | 0.9449 |
Summary
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
Eligibility Criteria
Key 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) 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
Data sourced from ClinicalTrials.gov (NCT03449446). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.