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Safety and Efficacy of Selonsertib, Firsocostat, Cilofexor, and Combinations in Participants With Bridging Fibrosis or Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (ATLAS)

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ClinicalTrials.gov Identifier: NCT03449446
Recruitment Status : Active, not recruiting
First Posted : February 28, 2018
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:

The primary objectives of this study are:

  • To assess the safety and tolerability of selonsertib (SEL), firsocostat, and cilofexor, administered alone or in combination, in participants with bridging fibrosis or compensated cirrhosis due to Nonalcoholic Steatohepatitis (NASH)
  • To evaluate changes in liver fibrosis, without worsening of NASH

Condition or disease Intervention/treatment Phase
Nonalcoholic Steatohepatitis Drug: SEL Drug: Firsocostat Drug: Cilofexor Drug: SEL Placebo Drug: Firsocostat Placebo Drug: Cilofexor Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 395 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib, Firsocostat, Cilofexor, and Combinations in Subjects With Bridging (F3) Fibrosis or Compensated Cirrhosis (F4) Due to Nonalcoholic Steatohepatitis (NASH)
Actual Study Start Date : March 21, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019


Arm Intervention/treatment
Experimental: SEL+ Firsocostat + Cilofexor Placebo
SEL + Firsocostat + Cilofexor Placebo for 48 weeks
Drug: SEL
18 mg tablet administered orally once daily without regard to food

Drug: Firsocostat
20 mg tablet administered orally once daily without regard to food
Other Name: GS-0976

Drug: Cilofexor Placebo
Tablet administered orally once daily without regard to food

Experimental: SEL+ Firsocostat Placebo + Cilofexor
SEL + Firsocostat Placebo + Cilofexor for 48 weeks
Drug: SEL
18 mg tablet administered orally once daily without regard to food

Drug: Cilofexor
30 mg tablet administered orally once daily without regard to food
Other Name: GS-9674

Drug: Firsocostat Placebo
Tablet administered orally once daily without regard to food

Experimental: SEL+ Firsocostat Placebo + Cilofexor Placebo
SEL + Firsocostat Placebo + Cilofexor Placebo for 48 weeks
Drug: SEL
18 mg tablet administered orally once daily without regard to food

Drug: Firsocostat Placebo
Tablet administered orally once daily without regard to food

Drug: Cilofexor Placebo
Tablet administered orally once daily without regard to food

Experimental: SEL Placebo + Firsocostat + Cilofexor Placebo
SEL Placebo + Firsocostat + Cilofexor Placebo for 48 weeks
Drug: Firsocostat
20 mg tablet administered orally once daily without regard to food
Other Name: GS-0976

Drug: SEL Placebo
Tablet administered orally once daily without regard to food

Drug: Cilofexor Placebo
Tablet administered orally once daily without regard to food

Experimental: SEL Placebo + Firsocostat Placebo + Cilofexor
SEL Placebo + Firsocostat Placebo + Cilofexor for 48 weeks
Drug: Cilofexor
30 mg tablet administered orally once daily without regard to food
Other Name: GS-9674

Drug: SEL Placebo
Tablet administered orally once daily without regard to food

Drug: Firsocostat Placebo
Tablet administered orally once daily without regard to food

Experimental: SEL Placebo + Firsocostat Placebo + Cilofexor Placebo
SEL Placebo + Firsocostat Placebo + Cilofexor Placebo for 48 weeks
Drug: SEL Placebo
Tablet administered orally once daily without regard to food

Drug: Firsocostat Placebo
Tablet administered orally once daily without regard to food

Drug: Cilofexor Placebo
Tablet administered orally once daily without regard to food

Experimental: SEL Placebo + Firsocostat + Cilofexor
SEL Placebo + Firsocostat + Cilofexor for 48 weeks
Drug: Firsocostat
20 mg tablet administered orally once daily without regard to food
Other Name: GS-0976

Drug: Cilofexor
30 mg tablet administered orally once daily without regard to food
Other Name: GS-9674

Drug: SEL Placebo
Tablet administered orally once daily without regard to food




Primary Outcome Measures :
  1. Proportion of Participants Experiencing Adverse Events [ Time Frame: Up to 52 Weeks ]
  2. Proportion of Participants Experiencing Laboratory Abnormalities [ Time Frame: Up to 52 weeks ]
  3. Proportion of Participants who Achieve a ≥ 1-Stage Improvement in fibrosis without worsening of NASH at Week 48 [ Time Frame: Week 48 ]
    Improvement in liver fibrosis will be evaluated by the Nonalcoholic Steatohepatitic (NASH) Clinical Research Network (CRN)classification.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Liver biopsy consistent with NASH and bridging fibrosis (F3) and cirrhosis (F4) in the opinion of the central reader
  • In participants who have never had a liver biopsy, liver stiffness by FibroScan® and Enhanced Liver Fibrosis (ELF™) Test score at Screening
  • Screening laboratory parameters, as determined by the central laboratory:

    • Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min, as calculated by the Cockcroft-Gault equation
    • HbA1c ≤ 9.5%
    • Alanine aminotransferase (ALT) < 5 x Upper Limits of Normal (ULN)
    • Platelet count ≥ 125,000/μL

Key Exclusion Criteria:

  • Prior history of decompensated liver disease including ascites, hepatic encephalopathy, or variceal bleeding
  • Child-Pugh (CP) score > 6 at Screening, unless due to an alternative etiology such as Gilbert's syndrome or therapeutic anticoagulation
  • Model for End-Stage Liver Disease (MELD) score > 12 at Screening, unless due to an alternate etiology such as therapeutic anticoagulation
  • Other causes of liver disease based on medical history and/or centralized review of liver histology, including but not limited to: alcoholic liver disease, hepatitis B, hepatitis C, autoimmune disorders (eg, primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis), drug-induced hepatotoxicity, Wilson disease, clinically significant iron overload, or alpha-1-antitrypsin deficiency requiring treatment
  • History of liver transplantation
  • Current or prior history of hepatocellular carcinoma

Note: Other protocol defined Inclusion/ Exclusion criteria may apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03449446


  Show 101 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT03449446     History of Changes
Other Study ID Numbers: GS-US-454-4378
First Posted: February 28, 2018    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases