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

Phase 2

Completed

• Conditions: Nonalcoholic Steatohepatitis (NASH)
• Interventions: Drug: GS-9674; Drug: Placebo to match GS-9674

• Registration Number: NCT02854605
• Lead Sponsor: Gilead Sciences

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-29
• Study First Submitted QC: 2016-07-29
• Study First Posted: 2016-08-03
• Study Start: 2016-10-26
• Primary Completion: 2018-01-09
• Study Completion: 2018-01-09
• Status Verified: 2019-01
• Results First Submitted: 2019-01-07
• Results First Submitted QC: 2019-01-07
• Last Update Submitted: 2019-01-07
• Results First Posted: 2019-01-29
• Last Update Posted: 2019-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Overall Safety of GS-9674 as Assessed By Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)	Up to 24 weeks plus 30 days	TEAEs were defined as 1 or both of the following: 1) Any adverse events (AE) with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug, 2) Any AEs leading to premature discontinuation of study drug.
Overall Safety of GS-9674 as Assessed By Percentage of Participants With Treatment-Emergent Laboratory Abnormalities	Up to 24 weeks plus 30 days	Treatment-emergent laboratory abnormalities are defined as values that increase at least 1 toxicity grade from baseline at any post-baseline time point, up to and including the date of last dose of study drug plus 30 days for participants who permanently discontinued study.

Trial Locations

Locations (37)

Ruane Clinical Research Group Inc.; 🇺🇸 Los Angeles, California, United States

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Inland Empire Liver Foundation; 🇺🇸 Rialto, California, United States

Clinical Research of South Florida; 🇺🇸 Coral Gables, Florida, United States

Atlanta Gastroenterology Associates; 🇺🇸 Atlanta, Georgia, United States

Northwestern Memorial Hospital, Clinical Research Unit; 🇺🇸 Chicago, Illinois, United States

Crescent Clinical Research Center, LLC; 🇺🇸 Metairie, Louisiana, United States

Tulane University Health Sciences Center; 🇺🇸 New Orleans, Louisiana, United States

Kansas City Research Institute; 🇺🇸 Kansas City, Missouri, United States

Concorde Medical Group, PLLC; 🇺🇸 New York, New York, United States

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