Phase 2
Completed N=140
Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Participants With Nonalcoholic Steatohepatitis (NASH)
Nonalcoholic Steatohepatitis (NASH)
Source: ClinicalTrials.gov NCT02854605 ↗
Enrolled (actual)
140
Serious AEs
3.6%
Results posted
Jan 2019
Primary outcomePrimary: Overall Safety of GS-9674 as Assessed By Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) — 89.3; 76.8; 67.9; 1.8 Percentage of participants
Summary
The primary objective of this study is to evaluate the safety and tolerability of GS-9674 in participants with nonalcoholic steatohepatitis (NASH).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Safety of GS-9674 as Assessed By Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) |
89.3; 76.8; 67.9; 1.8; 8.9; 7.1 | — |
| PRIMARY Overall Safety of GS-9674 as Assessed By Percentage of Participants With Treatment-Emergent Laboratory Abnormalities |
89.3; 92.9; 92.9; 35.7; 42.9; 50.0 | — |
Eligibility Criteria
Key Inclusion Criteria
- Meets 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 kilopascal (kPa) OR
- A historical liver biopsy within 12 months of screening consistent with NASH with fibrosis, but not cirrhosis, and
- No documented weight loss > 5% between the date of the liver biopsy and screening.
- Platelet count ≥ 150,000/mm^3
- Albumin ≥ 3.3 g/dL
- Serum creatinine ≤ upper limit of normal (ULN)
Key Exclusion Criteria
- Pregnant or lactating females
- Alanine aminotransferase (ALT) > 5x 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) 9% at screening)
- International normalized ratio (INR) > 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 (NCT02854605). 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.