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OpenTrials
Completed

NCT Number: NCT03449446

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

The primary objectives of this study are:

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Royal Brisbane & Women's Hospital, Herston, Queensland, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Liver biopsy consistent with NASH and F3 or F4 in the opinion of the central reader
  • In participants who have never had a liver biopsy, liver stiffness by FibroScan® ≥ 14.0 kPa and Enhanced Liver Fibrosis (ELF™) Test score ≥ 9.8 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
  • Hemoglobin A1c (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

Treatment and study plan

SEL

Drug

18 mg tablet administered orally once daily without regard to food

FIR

Drug

20 mg tablet administered orally once daily without regard to food

Other names: GS-0976

CILO

Drug

30 mg tablet administered orally once daily without regard to food

Other names: GS-9674

Placebo to match FIR

Drug

Tablet administered orally once daily without regard to food

Placebo to match CILO

Drug

Tablet administered orally once daily without regard to food

Placebo to match SEL

Drug

Tablet administered orally once daily without regard to food

Primary outcomes

  1. Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)

    Time frame: First dose date up to 48 weeks plus 30 days

  2. Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities

    Time frame: First dose date up to 48 weeks plus 30 days

    Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. Participants with any laboratory abnormality were reported.

  3. Percentage of Participants Who Achieved a ≥ 1-Stage Improvement in Fibrosis Without Worsening of NASH at Week 48

    Time frame: Week 48

    Fibrosis improvement was defined as ≥ 1-stage decrease from baseline in fibrosis according to the NASH clinical research network classification (CRN) classification. Worsening of NASH was defined as ≥ 1-point increase from baseline in hepatocellular ballooning or lobular inflammation. The 95% CI was based on the Clopper-Pearson method.

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib, GS-0976, GS-9674, and Combinations in Subjects With Bridging (F3) Fibrosis or Compensated Cirrhosis (F4) Due to Nonalcoholic Steatohepatitis (NASH)

Acronym: ATLAS

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 28, 2018
Registry last updated
Dec 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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