Status and phase
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Study type
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About
The primary objective of this study is to evaluate the safety and tolerability of GS-9674 in participants with nonalcoholic steatohepatitis (NASH).
Enrollment
Sex
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Volunteers
Inclusion and exclusion criteria
Key Inclusion Criteria:
Meets the following conditions:
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
Body mass index (BMI) < 18 kg/m^2
Uncontrolled diabetes mellitus (hemoglobin A1c > 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.
Primary purpose
Allocation
Interventional model
Masking
140 participants in 3 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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