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

Phase 2

Completed

• Conditions: Nonalcoholic Steatohepatitis (NASH)
• Interventions: Drug: Firsocostat; Drug: Placebo

• Registration Number: NCT02856555
• Lead Sponsor: Gilead Sciences

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-02
• Study First Submitted QC: 2016-08-04
• Study First Posted: 2016-08-05
• Study Start: 2016-08-08
• Primary Completion: 2017-07-18
• Study Completion: 2017-07-18
• Disposition First Submitted: 2018-07-09
• Disposition First Submitted QC: 2018-07-09
• Disposition First Posted: 2018-07-11
• Status Verified: 2020-07
• Results First Submitted: 2020-07-08
• Results First Submitted QC: 2020-07-08
• Last Update Submitted: 2020-07-08
• Results First Posted: 2020-07-24
• Last Update Posted: 2020-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Firsocostat 20 mg	Placebo	Participants will receive firsocostat 2 X 10 mg + 2 x placebo matched to firsocostat 5 mg for 12 weeks.
Placebo	Placebo	Participants will receive 2 x placebo matched to firsocostat 5 mg + 2 x placebo matched to firsocostat 10 mg for 12 weeks.
Firsocostat 5 mg	Placebo	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.
Firsocostat 20 mg	Firsocostat	Participants will receive firsocostat 2 X 10 mg + 2 x placebo matched to firsocostat 5 mg for 12 weeks.
Firsocostat 5 mg	Firsocostat	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Experiencing Treatment-Emergent Adverse Events	First Dose date up to last dose (Week 12) plus 30 days