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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02781584




Registration number
NCT02781584
Ethics application status
Date submitted
20/05/2016
Date registered
24/05/2016
Date last updated
13/06/2019

Titles & IDs
Public title
Safety, Tolerability, and Efficacy of Selonsertib, Firsocostat, and Cilofexor in Adults With Nonalcoholic Steatohepatitis (NASH)
Scientific title
A Proof of Concept, Open-Label Study Evaluating the Safety, Tolerability, and Efficacy of Regimens in Subjects With Nonalcoholic Steatohepatitis (NASH)
Secondary ID [1] 0 0
GS-US-384-3914
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 - SEL
Treatment: Drugs - Firsocostat
Treatment: Drugs - Cilofexor
Treatment: Drugs - Fenofibrate

Experimental: SEL (Cohort 1) - SEL (1 x 18 mg tablet) for 12 weeks

Experimental: Firsocostat (Cohort 2) - Firsocostat (2 x 10 mg capsules) for 12 weeks
Enrollment into Cohort 2 will begin upon completion of enrollment for Cohort 1.

Experimental: Cilofexor (Cohort 3) - Cilofexor (3 x 10 mg tablets) for 12 weeks
Enrollment into Cohort 3 will begin upon completion of enrollment for Cohort 2.

Experimental: SEL+ Cilofexor(Cohort 4) - SEL (1 x 18 mg tablet) + Cilofexor (1 x 30 mg tablet) for 12 weeks
Enrollment into Cohort 4 will begin upon completion of enrollment for Cohort 3.

Experimental: SEL + Firsocostat(Cohort 5) - SEL (1 x 18 mg tablet) + firsocostat (1 x 20 mg tablet) for 12 weeks
Enrollment into Cohort 5 will begin upon completion of enrollment for Cohort 4.

Experimental: Firsocostat + Cilofexor(Cohort 6) - Firsocostat (1 x 20 mg tablet) + Cilofexor (1 x 30 mg tablet) for 12 weeks
Enrollment into Cohort 6 will begin upon completion of enrollment for Cohort 5.

Experimental: Firsocostat Cirrhotic (Cohort 7) - Firsocostat (1 x 20 mg tablet) for 12 weeks (participants with Child-Pugh-Turcotte Class A (CPT A) cirrhosis)
Enrollment into Cohorts 7 and 8 will be randomized in parallel.

Experimental: Cilofexor Cirrhotic (Cohort 8) - Cilofexor (1 x 30 mg tablet) for 12 weeks (participants with CPT A cirrhosis)
Enrollment into Cohorts 7 and 8 will be randomized in parallel.

Experimental: SEL + Firsocostat + Cilofexor (Cohort 9) - SEL (1 x 18 mg tablet) + Firsocostat (1 x 20 mg tablet) + Cilofexor (1 x 30 mg tablet) for 12 weeks
Enrollment into Cohort 9 will begin upon completion of enrollment for Cohort 6.

Experimental: Firsocostat + Fenofibrate 48 mg (Cohort 10) - Pre-treatment with fenofibrate 48 mg from Day -14 to Day -1 and will be treated with firsocostat (1 x 20 mg tablet) + fenofibrate (1 x 48 mg tablet) for 24 weeks

Experimental: Firsocostat + Fenofibrate 145 mg (Cohort 11) - Pre-treatment with fenofibrate 145 mg from Day -14 to Day -1 and will be treated with firsocostat (1 x 20 mg tablet) + fenofibrate (1 x 145 mg tablet) for 24 weeks


Treatment: Drugs: SEL
Administered orally once daily

Treatment: Drugs: Firsocostat
Administered orally once daily

Treatment: Drugs: Cilofexor
Administered orally once daily

Treatment: Drugs: Fenofibrate
Administered orally once daily

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Treatment-Emergent Adverse Events
Timepoint [1] 0 0
Up to 24 weeks plus 30 days
Primary outcome [2] 0 0
Incidence of Treatment-Emergent Serious Adverse Events
Timepoint [2] 0 0
Up to 24 weeks plus 30 days
Primary outcome [3] 0 0
Incidence of Treatment-Emergent Laboratory Abnormalities
Timepoint [3] 0 0
Up to 24 weeks plus 30 days

Eligibility
Key inclusion criteria
Key

- Males and females between 18-75 years of age (Cohorts 1-9: 18-75 years and Cohorts
10-11: = 18 years); inclusive based on the date of the screening visit

- Willing and able to provide informed consent prior to any study specific procedures
being performed

- Meets the following conditions (Cohorts 1-6 and 9):

- Clinical diagnosis of non-alcoholic fatty liver disease and evidence of F2-3
fibrosis

- For Cohorts 7 and 8, participants must have a clinical diagnosis of NAFLD and
cirrhosis

- For Cohorts 10 and 11, individuals must have a clinical diagnosis of NAFLD and meet
one of the following criteria :

- a) A historical liver biopsy within 6 months of Screening consistent with NASH
and bridging fibrosis (F3) or within 12 months of Screening consistent with NASH
and compensated cirrhosis (F4) in the opinion of the investigator,

- b) Screening liver stiffness by MRE = 3.64 kPa;

- c) Screening liver stiffness by FibroScan® = 9.9 kPa;

Key
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pregnant or lactating females

- Other causes of liver disease including autoimmune, viral, and alcoholic liver disease

- Any history of decompensated liver disease, including ascites, hepatic encephalopathy
or variceal bleeding

- For Cohorts 7, 8, 10, and 11, Child-Pugh-Turcotte (CPT) score > 6

- History of liver transplantation

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Tennessee
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
New Zealand
State/province [5] 0 0
Auckland

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 selonsertib
(SEL; formerly GS-4997), firsocostat, cilofexor and /or fenofibrate in adults with
nonalcoholic steatohepatitis (NASH).
Trial website
https://clinicaltrials.gov/show/NCT02781584
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
Other publications