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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02854605




Registration number
NCT02854605
Ethics application status
Date submitted
29/07/2016
Date registered
3/08/2016
Date last updated
29/01/2019

Titles & IDs
Public title
Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Participants With Nonalcoholic Steatohepatitis (NASH)
Scientific 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)
Secondary ID [1] 0 0
2016-002496-10
Secondary ID [2] 0 0
GS-US-402-1852
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nonalcoholic Steatohepatitis (NASH) 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Diet and Nutrition 0 0 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GS-9674
Treatment: Drugs - Placebo to match GS-9674

Experimental: GS-9674 30 mg - GS-9674 30 mg + placebo to match GS-9674 100 mg for 24 weeks

Experimental: GS-9674 100 mg - GS-9674 100 mg + placebo to match GS-9674 30 mg for 24 weeks

Placebo Comparator: Placebo - Placebo to match GS-9674 30 mg + placebo to match GS-9674 100 mg for 24 weeks


Treatment: Drugs: GS-9674
Tablet administered orally once daily

Treatment: Drugs: Placebo to match GS-9674
Tablet(s) administered orally once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Safety of GS-9674 as Assessed By Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
Up to 24 weeks plus 30 days
Primary outcome [2] 0 0
Overall Safety of GS-9674 as Assessed By Percentage of Participants With Treatment-Emergent Laboratory Abnormalities
Timepoint [2] 0 0
Up to 24 weeks plus 30 days

Eligibility
Key inclusion criteria
Key

- 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/10/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/01/2018
Sample size
Target
Accrual to date
Final
140
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Utah
Country [13] 0 0
United States of America
State/province [13] 0 0
Virginia
Country [14] 0 0
United States of America
State/province [14] 0 0
Washington
Country [15] 0 0
Canada
State/province [15] 0 0
Alberta
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
Hong Kong
State/province [17] 0 0
Kowloon
Country [18] 0 0
Hong Kong
State/province [18] 0 0
Sha Tin
Country [19] 0 0
New Zealand
State/province [19] 0 0
Auckland
Country [20] 0 0
Switzerland
State/province [20] 0 0
Bern
Country [21] 0 0
Switzerland
State/province [21] 0 0
Zurich
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Cambridge

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of this study is to evaluate the safety and tolerability of GS-9674 in
participants with nonalcoholic steatohepatitis (NASH).
Trial website
https://clinicaltrials.gov/ct2/show/NCT02854605
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02854605