Phase 2
Completed N=127
Study to Evaluate Safety, Tolerability, and Efficacy of GS-0976 in Adults With Nonalcoholic Steatohepatitis
Nonalcoholic Steatohepatitis (NASH)
Source: ClinicalTrials.gov NCT02856555 ↗
Enrolled (actual)
127
Serious AEs
3.2%
Results posted
Jul 2020
Primary outcomePrimary: Percentage of Participants Experiencing Treatment-Emergent Adverse Events — 70.6; 71.4; 61.5 percentage of participants
Summary
The primary objective of this study is to evaluate the safety and tolerability of firsocostat in adults with nonalcoholic steatohepatitis (NASH).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Experiencing Treatment-Emergent Adverse Events |
70.6; 71.4; 61.5 | — |
Eligibility Criteria
Key Inclusion Criteria
- Meets all of the following conditions:
- A clinical diagnosis of nonalcoholic fatty liver disease (NAFLD)
- Screening magnetic resonance imaging - proton density fat fraction (MRI-PDFF) with ≥ 8% steatosis
- Screening magnetic resonance elastography (MRE) with liver stiffness ≥ 2.5 kPa
- OR
- A historical liver biopsy consistent with NASH and non-cirrhotic fibrosis
- Platelet count ≥ 100,000/mm^3
- Creatinine Clearance (CLcr ) as calculated by the Cockcroft-Gault equation ≥ 60 ml/min
Key Exclusion Criteria
- Pregnant or lactating females
- Alanine aminotransferase (ALT) > 5 x upper limit of the normal range (ULN)
- Other causes of liver disease including autoimmune, viral, and alcoholic liver disease
- Cirrhosis of the liver
- Prior history of decompensated liver disease, including ascites, hepatic encephalopathy or variceal bleeding
- Body mass index (BMI) 1.2 unless on anticoagulant therapy
- Total bilirubin > 1 x ULN, except with diagnosis of Gilbert's syndrome
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02856555). 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.