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

Nonalcoholic Steatohepatitis (NASH) Clinical Trial

Official title:

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Subjects With Nonalcoholic Steatohepatitis (NASH)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02854605
• Other study ID #: GS-US-402-1852
• Secondary ID: 2016-002496-10
• Status: Completed
• Phase: Phase 2
• Start date: October 26, 2016
• Est. completion date: January 9, 2018

Study information

• Verified date: January 2019
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: January 9, 2018
• Est. primary completion date: January 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Steatohepatitis (NASH)

Intervention

Drug:
• GS-9674
Tablet administered orally once daily
• Placebo to match GS-9674
Tablet(s) administered orally once daily

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	LMC Clinical Research Inc (Bayview)	Toronto	Ontario
Canada	Toronto General Hospital	Toronto	Ontario
Canada	Toronto Liver Center	Toronto	Ontario
Canada	Toronto Digestive Disease Associates, Inc.	Vaughan	Ontario
Hong Kong	Princess Margaret Hospital	Kowloon
Hong Kong	The Chinese University of Hong Kong	Sha Tin
New Zealand	Auckland Clinical Studies	Auckland
Switzerland	Universitatsspital Bern, Inselspital, Universitatsklinik fur Viszerale Chirurgie und Medizin, Hepatologie	Bern
Switzerland	Universitatsspital Zurich	Zurich
United Kingdom	Addenbrooke's Hospital	Cambridge
United States	Texas Clinical Research Institute	Arlington	Texas
United States	Atlanta Gastroenterology Associates	Atlanta	Georgia
United States	Northwestern Memorial Hospital, Clinical Research Unit	Chicago	Illinois
United States	Clinical Research of South Florida	Coral Gables	Florida
United States	Texas Digestive Disease Consultants	Dallas	Texas
United States	The Liver Institute at Methodist Dallas Medical Center	Dallas	Texas
United States	Carolinas Center for Liver Disease/Carolinas HealthCare System	Durham	North Carolina
United States	Duke University Medical Center, Duke South Clinics	Durham	North Carolina
United States	Gastro One	Germantown	Tennessee
United States	Houston Methodist Hospital	Houston	Texas
United States	Kansas City Research Institute	Kansas City	Missouri
United States	Pinnacle Clinical Research	Live Oak	Texas
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	Ruane Clinical Research Group Inc.	Los Angeles	California
United States	Crescent Clinical Research Center, LLC	Metairie	Louisiana
United States	Intermountain Liver Disease and Transplant Center	Murray	Utah
United States	Quality Medical Research, PC	Nashville	Tennessee
United States	Tulane University Health Sciences Center	New Orleans	Louisiana
United States	Concorde Medical Group, PLLC	New York	New York
United States	Bon Secours St. Mary's Hospital of Richmond, Inc d/b/a Bon Secours Liver Institute of Virginia	Newport News	Virginia
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Inland Empire Liver Foundation	Rialto	California
United States	Bon Secours St. Mary's Hospital of Richmond, Inc. d/b/a Bon Secours Liver Institute of Virginia	Richmond	Virginia
United States	McGuire VA Medical Center	Richmond	Virginia
United States	American Research Corporation at the Texas Liver Institute	San Antonio	Texas
United States	Swedish Organ Transplant and Liver Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Canada,  Hong Kong,  New Zealand,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Safety of GS-9674 as Assessed By Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)	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.	Up to 24 weeks plus 30 days
Primary	Overall Safety of GS-9674 as Assessed By Percentage of Participants With Treatment-Emergent Laboratory Abnormalities	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.	Up to 24 weeks plus 30 days