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

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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

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

Trial documents
4

Trial contacts and locations

37

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Data sourced from clinicaltrials.gov

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