Phase 2
Completed 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)
Source: ClinicalTrials.gov NCT03449446 ↗Enrolled (actual)
395
Serious AEs
11.5%
Results posted
Dec 2020
Primary outcomePrimary: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) — 84.6; 85.0; 92.5; 88.6 percentage of participants
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
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 |
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. Informational only — not medical advice.