Study to Evaluate Safety, Tolerability, and Efficacy of GS-0976 in Adults With Nonalcoholic Steatohepatitis

Gilead Sciences

Status and phase: Completed; Phase 2

Conditions: Nonalcoholic Steatohepatitis (NASH)

Treatments: Drug: Firsocostat; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02856555

GS-US-426-3989

Details and patient eligibility

About

The primary objective of this study is to evaluate the safety and tolerability of firsocostat in adults with nonalcoholic steatohepatitis (NASH).

Enrollment: 127 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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) < 18 kg/m^2

• 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: Sequential Assignment

Masking: Double Blind

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127 participants in 3 patient groups

Firsocostat 5 mg

Experimental group

Description:

Participants will receive firsocostat 1 x 5 mg + 1 x placebo matched to firsocostat 5 mg + 2 x placebo matched to firsocostat 10 mg for 12 weeks.

Treatment:

Drug: Placebo

Drug: Firsocostat

Firsocostat 20 mg

Experimental group

Description:

Participants will receive firsocostat 2 X 10 mg + 2 x placebo matched to firsocostat 5 mg for 12 weeks.

Treatment:

Drug: Placebo

Drug: Firsocostat

Placebo

Experimental group

Description:

Participants will receive 2 x placebo matched to firsocostat 5 mg + 2 x placebo matched to firsocostat 10 mg for 12 weeks.

Treatment:

Drug: Placebo