Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Participants With Nonalcoholic Steatohepatitis (NASH)

Gilead Sciences

Status and phase: Completed; Phase 2

Conditions: Nonalcoholic Steatohepatitis (NASH)

Treatments: Drug: Placebo to match GS-9674; Drug: GS-9674

Study type: Interventional

Funder types: Industry

Identifiers

NCT02854605

GS-US-402-1852

2016-002496-10 (EudraCT Number)

Details and patient eligibility

About

The primary objective of this study is to evaluate the safety and tolerability of GS-9674 in participants with nonalcoholic steatohepatitis (NASH).

Enrollment: 140 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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) < 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 3 patient groups, including a placebo group

GS-9674 30 mg

Experimental group

Description:

GS-9674 30 mg + placebo to match GS-9674 100 mg for 24 weeks

Treatment:

Drug: Placebo to match GS-9674

Drug: GS-9674

GS-9674 100 mg

Experimental group

Description:

GS-9674 100 mg + placebo to match GS-9674 30 mg for 24 weeks

Treatment:

Drug: Placebo to match GS-9674

Drug: GS-9674

Placebo

Placebo Comparator group

Description:

Placebo to match GS-9674 30 mg + placebo to match GS-9674 100 mg for 24 weeks

Treatment:

Drug: Placebo to match GS-9674