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- | selonsertib (GS-4997) / Gilead
Preclinical, Journal: Development and validation of an in vitro 3D model of NASH with severe fibrotic phenotype. (Pubmed Central) - Apr 12, 2019
We further validated the model using a phase 3 clinical compound, GS-4997, an apoptosis signal-regulating kinase 1 (ASK-1) inhibitor and showed that GS-4997 significantly decreased PA induced profibrotic and proinflammatory response in the 3D-hLMTs with decreases in apoptosis and stellate cell activation in the microtissues. Taken together we have established and validated an in vitro 3D-hLMT NASH model with severe fibrotic phenotype that can be a powerful tool to investigate experimental compounds for the treatment of NASH.
- |||| selonsertib (GS-4997) / Gilead
Trial completion date, Trial primary completion date: STELLAR 4: Safety and Efficacy of Selonsertib in Adults With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - Mar 5, 2019
P3, N=883, Active, not recruiting, Sponsor: Gilead Sciences
Taken together we have established and validated an in vitro 3D-hLMT NASH model with severe fibrotic phenotype that can be a powerful tool to investigate experimental compounds for the treatment of NASH. Trial completion date: Nov 2022 --> Apr 2019 | Trial primary completion date: Nov 2022 --> Apr 2019
- || selonsertib (GS-4997) / Gilead, Firsocostat (GS-0976) / Gilead, cilofexor (GS-9674) / Gilead
Enrollment closed: Safety, Tolerability, and Efficacy of Selonsertib, Firsocostat, and Cilofexor in Adults With Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - Feb 18, 2019
P2, N=154, Active, not recruiting, Sponsor: Gilead Sciences
Trial completion date: Nov 2022 --> Apr 2019 | Trial primary completion date: Nov 2022 --> Apr 2019 Recruiting --> Active, not recruiting
- |||| selonsertib (GS-4997) / Gilead
Trial primary completion date: STELLAR 3: Safety and Efficacy of Selonsertib in Adults With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis (clinicaltrials.gov) - Jan 22, 2019
P3, N=808, Active, not recruiting, Sponsor: Gilead Sciences
Recruiting --> Active, not recruiting Trial primary completion date: Mar 2019 --> Feb 2023
- |||| selonsertib (GS-4997) / Gilead
Trial primary completion date: STELLAR 4: Safety and Efficacy of Selonsertib in Adults With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - Jan 22, 2019
P3, N=883, Active, not recruiting, Sponsor: Gilead Sciences
Trial primary completion date: Mar 2019 --> Feb 2023 Trial primary completion date: Jan 2019 --> Nov 2022
- | Enrollment closed: ATLAS: 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) (clinicaltrials.gov) - Nov 16, 2018
P2, N=395, Active, not recruiting, Sponsor: Gilead Sciences
Trial primary completion date: Jan 2019 --> Nov 2022 Recruiting --> Active, not recruiting
- | P2 data, Review, Journal: Future Pharmacotherapy for Non-alcoholic Steatohepatitis (NASH): Review of Phase 2 and 3 Trials. (Pubmed Central) - Oct 3, 2018
The past decade has seen an explosion of interest in drug development targeting pathologic pathways in non-alcoholic steatohepatitis, with numerous phase 2 and 3 trials currently in progress. Here, we concisely review the major targets and mechanisms of action by class, summarize results from completed pivotal phase 2 studies, and provide a detailed outline of key active studies with trial data for drugs in development, including obeticholic acid, elafibranor, cenicriviroc and selonsertib.
- | Trial completion date, Trial primary completion date: ATLAS: 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) (clinicaltrials.gov) - Aug 1, 2018
P2, N=350, Recruiting, Sponsor: Gilead Sciences
Here, we concisely review the major targets and mechanisms of action by class, summarize results from completed pivotal phase 2 studies, and provide a detailed outline of key active studies with trial data for drugs in development, including obeticholic acid, elafibranor, cenicriviroc and selonsertib. Trial completion date: Apr 2020 --> Dec 2019 | Trial primary completion date: Mar 2020 --> Dec 2019
- ||| selonsertib (GS-4997) / Gilead, Firsocostat (GS-0976) / Gilead, cilofexor (GS-9674) / Gilead
Enrollment open, Trial completion date, Trial primary completion date: Safety, Tolerability, and Efficacy of Selonsertib, Firsocostat, and Cilofexor in Adults With Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - Jul 2, 2018
P2, N=150, Recruiting, Sponsor: Gilead Sciences
Trial completion date: Apr 2020 --> Dec 2019 | Trial primary completion date: Mar 2020 --> Dec 2019 Active, not recruiting --> Recruiting | Trial completion date: May 2018 --> Jul 2019 | Trial primary completion date: Apr 2018 --> Jul 2019
- ||| selonsertib (GS-4997) / Gilead
Trial completion, Combination therapy: Selonsertib in Combination With Prednisolone Versus Prednisolone Alone in Participants With Severe Alcoholic Hepatitis (AH) (clinicaltrials.gov) - Jun 4, 2018
P2, N=103, Completed, Sponsor: Gilead Sciences
Active, not recruiting --> Recruiting | Trial completion date: May 2018 --> Jul 2019 | Trial primary completion date: Apr 2018 --> Jul 2019 Active, not recruiting --> Completed
- ||||| selonsertib (GS-4997) / Gilead
Enrollment closed, Trial completion date, Trial primary completion date: STELLAR 3: Safety and Efficacy of Selonsertib in Adults With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis (clinicaltrials.gov) - Apr 27, 2018
P3, N=808, Active, not recruiting, Sponsor: Gilead Sciences
Active, not recruiting --> Completed Recruiting --> Active, not recruiting | Trial completion date: Oct 2023 --> Feb 2023 | Trial primary completion date: Jan 2020 --> Mar 2019
- |||| Enrollment open: ATLAS: 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) (clinicaltrials.gov) - Apr 8, 2018
P2, N=350, Recruiting, Sponsor: Gilead Sciences
Recruiting --> Active, not recruiting | Trial completion date: Oct 2023 --> Feb 2023 | Trial primary completion date: Jan 2020 --> Mar 2019 Not yet recruiting --> Recruiting
- || selonsertib (GS-4997) / Gilead
Trial primary completion date, Combination therapy: Selonsertib in Combination With Prednisolone Versus Prednisolone Alone in Participants With Severe Alcoholic Hepatitis (AH) (clinicaltrials.gov) - Mar 7, 2018
P2, N=103, Active, not recruiting, Sponsor: Gilead Sciences
Not yet recruiting --> Recruiting Trial primary completion date: Feb 2018 --> Feb 2018
- ||||| New P2 trial: ATLAS: 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) (clinicaltrials.gov) - Feb 27, 2018
P2, N=350, Not yet recruiting, Sponsor: Gilead Sciences
- ||||| selonsertib (GS-4997) / Gilead
Enrollment closed, Trial completion date, Trial primary completion date: STELLAR 4: Safety and Efficacy of Selonsertib in Adults With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - Feb 26, 2018
P3, N=883, Active, not recruiting, Sponsor: Gilead Sciences
Trial primary completion date: Feb 2018 --> Feb 2018 Recruiting --> Active, not recruiting | Trial primary completion date: Jan 2020 --> Jan 2019 | Trial completion date: Oct 2023 --> Nov 2022
- ||| selonsertib (GS-4997) / Gilead, Firsocostat (GS-0976) / Gilead, cilofexor (GS-9674) / Gilead
Enrollment closed: Safety, Tolerability, and Efficacy of Selonsertib, Firsocostat, and Cilofexor in Adults With Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - Feb 8, 2018
P2, N=123, Active, not recruiting, Sponsor: Gilead Sciences
Recruiting --> Active, not recruiting | Trial primary completion date: Jan 2020 --> Jan 2019 | Trial completion date: Oct 2023 --> Nov 2022 Recruiting --> Active, not recruiting
- ||| selonsertib (GS-4997) / Gilead
Enrollment closed, Combination therapy: Selonsertib in Combination With Prednisolone Versus Prednisolone Alone in Participants With Severe Alcoholic Hepatitis (AH) (clinicaltrials.gov) - Jan 10, 2018
P2, N=103, Active, not recruiting, Sponsor: Gilead Sciences
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- |||||||||| selonsertib (GS-4997) / Gilead
Enrollment change, Trial withdrawal, Trial primary completion date: Evaluation of HepQuant SHUNT to Assess Liver Disease; Substudy Within GS-US-416-2124 (clinicaltrials.gov) - Sep 15, 2017
P, N=0, Withdrawn, Sponsor: HepQuant, LLC
Recruiting --> Active, not recruiting N=60 --> 0 | Recruiting --> Withdrawn | Trial primary completion date: Apr 2018 --> Sep 2017
- ||| selonsertib (GS-4997) / Gilead, Firsocostat (GS-0976) / Gilead, cilofexor (GS-9674) / Gilead
Enrollment change, Trial primary completion date: Safety, Tolerability, and Efficacy of Selonsertib, Firsocostat, and Cilofexor in Adults With Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - May 8, 2017
P2, N=110, Recruiting, Sponsor: Gilead Sciences
N=60 --> 0 | Recruiting --> Withdrawn | Trial primary completion date: Apr 2018 --> Sep 2017 N=50 --> 110 | Trial primary completion date: Sep 2017 --> Mar 2018
- || selonsertib (GS-4997) / Gilead
Trial primary completion date, Combination therapy: Selonsertib in Combination With Prednisolone Versus Prednisolone Alone in Participants With Severe Alcoholic Hepatitis (AH) (clinicaltrials.gov) - Apr 6, 2017
P2, N=120, Recruiting, Sponsor: Gilead Sciences
N=50 --> 110 | Trial primary completion date: Sep 2017 --> Mar 2018 Trial primary completion date: Apr 2018 --> Jan 2018
- || selonsertib (GS-4997) / Gilead
Trial primary completion date, Combination therapy: Selonsertib in Combination With Prednisolone Versus Prednisolone Alone in Participants With Severe Alcoholic Hepatitis (AH) (clinicaltrials.gov) - Mar 3, 2017
P2, N=120, Recruiting, Sponsor: Gilead Sciences
Trial primary completion date: Apr 2018 --> Jan 2018 Trial primary completion date: Oct 2017 --> Apr 2018
- | selonsertib (GS-4997) / Gilead, Firsocostat (GS-0976) / Gilead, cilofexor (GS-9674) / Gilead
Enrollment change, Trial primary completion date: Safety, Tolerability, and Efficacy of Selonsertib, Firsocostat, and Cilofexor in Adults With Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - Feb 15, 2017
P2, N=50, Recruiting, Sponsor: Gilead Sciences
Trial primary completion date: Oct 2017 --> Apr 2018 N=30 --> 50 | Trial primary completion date: Mar 2017 --> Sep 2017
- |||||||||| selonsertib (GS-4997) / Gilead
New P3 trial: STELLAR 3: Safety and Efficacy of Selonsertib in Adults With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis (clinicaltrials.gov) - Feb 14, 2017
P3, N=800, Recruiting, Sponsor: Gilead Sciences
- |||||||||| selonsertib (GS-4997) / Gilead
New P3 trial: STELLAR 4: Safety and Efficacy of Selonsertib in Adults With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - Feb 14, 2017
P3, N=800, Recruiting, Sponsor: Gilead Sciences
- |||| selonsertib (GS-4997) / Gilead
Trial completion: ARROW: Selonsertib in Adults With Pulmonary Arterial Hypertension (clinicaltrials.gov) - Dec 23, 2016
P2, N=151, Completed, Sponsor: Gilead Sciences
N=30 --> 50 | Trial primary completion date: Mar 2017 --> Sep 2017 Active, not recruiting --> Completed
- |||| selonsertib (GS-4997) / Gilead, simtuzumab (GS 6624) / Gilead
Trial completion, Combination therapy: Safety, Tolerability, and Efficacy of GS-4997 Alone or in Combination With Simtuzumab (SIM) in Adults With Nonalcoholic Steatohepatitis (NASH) and Fibrosis Stages F2-F3 (clinicaltrials.gov) - Nov 15, 2016
P2, N=72, Completed, Sponsor: Gilead Sciences
Active, not recruiting --> Completed Active, not recruiting --> Completed
- |||| selonsertib (GS-4997) / Gilead
Enrollment open, Combination therapy: Selonsertib in Combination With Prednisolone Versus Prednisolone Alone in Participants With Severe Alcoholic Hepatitis (AH) (clinicaltrials.gov) - Sep 19, 2016
P2, N=120, Recruiting, Sponsor: Gilead Sciences
Active, not recruiting --> Completed Not yet recruiting --> Recruiting
- selonsertib (GS-4997) / Gilead, Firsocostat (GS-0976) / Gilead, cilofexor (GS-9674) / Gilead
Trial primary completion date: Safety, Tolerability, and Efficacy of Selonsertib, Firsocostat, and Cilofexor in Adults With Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - Sep 15, 2016
P2, N=30, Recruiting, Sponsor: Gilead Sciences
Not yet recruiting --> Recruiting Trial primary completion date: Oct 2016 --> Mar 2017
- |||| selonsertib (GS-4997) / Gilead
Trial completion: Efficacy, Safety, and Tolerability of Selonsertib (GS-4997) in Participants With Diabetic Kidney Disease (clinicaltrials.gov) - Sep 1, 2016
P2, N=334, Completed, Sponsor: Gilead Sciences
Trial primary completion date: Oct 2016 --> Mar 2017 Active, not recruiting --> Completed
- | selonsertib (GS-4997) / Gilead, Firsocostat (GS-0976) / Gilead, cilofexor (GS-9674) / Gilead
Enrollment change: Safety, Tolerability, and Efficacy of Selonsertib, Firsocostat, and Cilofexor in Adults With Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - Aug 9, 2016
P2, N=30, Recruiting, Sponsor: Gilead Sciences
Active, not recruiting --> Completed N=10 --> 30
- ||||| selonsertib (GS-4997) / Gilead
New P2 trial, Combination therapy: Selonsertib in Combination With Prednisolone Versus Prednisolone Alone in Participants With Severe Alcoholic Hepatitis (AH) (clinicaltrials.gov) - Aug 3, 2016
P2, N=120, Not yet recruiting, Sponsor: Gilead Sciences
- selonsertib (GS-4997) / Gilead, Firsocostat (GS-0976) / Gilead, cilofexor (GS-9674) / Gilead
Enrollment open: Safety, Tolerability, and Efficacy of Selonsertib, Firsocostat, and Cilofexor in Adults With Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - Jun 23, 2016
P2, N=10, Recruiting, Sponsor: Gilead Sciences
N=10 --> 30 Not yet recruiting --> Recruiting
- selonsertib (GS-4997) / Gilead, Firsocostat (GS-0976) / Gilead, cilofexor (GS-9674) / Gilead
New P2 trial: Safety, Tolerability, and Efficacy of Selonsertib, Firsocostat, and Cilofexor in Adults With Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - May 24, 2016
P2, N=10, Not yet recruiting, Sponsor: Gilead Sciences
- ||| selonsertib (GS-4997) / Gilead
Enrollment change: ARROW: Selonsertib in Adults With Pulmonary Arterial Hypertension (clinicaltrials.gov) - May 20, 2016
P2, N=151, Active, not recruiting, Sponsor: Gilead Sciences
Not yet recruiting --> Recruiting N=120 --> 151
- ||| selonsertib (GS-4997) / Gilead, simtuzumab (GS 6624) / Gilead
Enrollment closed, Combination therapy: Safety, Tolerability, and Efficacy of GS-4997 Alone or in Combination With Simtuzumab (SIM) in Adults With Nonalcoholic Steatohepatitis (NASH) and Fibrosis Stages F2-F3 (clinicaltrials.gov) - Apr 7, 2016
P2, N=72, Active, not recruiting, Sponsor: Gilead Sciences
N=120 --> 151 Recruiting --> Active, not recruiting
- ||| selonsertib (GS-4997) / Gilead
Trial completion, Trial primary completion date: Study to Evaluate the Pharmacokinetics of Selonsertib in Participants With Normal and Impaired Hepatic Function (clinicaltrials.gov) - Dec 22, 2015
P1, N=60, Completed, Sponsor: Gilead Sciences
Recruiting --> Active, not recruiting Recruiting --> Completed | Trial primary completion date: Apr 2016 --> Dec 2015
- ||| selonsertib (GS-4997) / Gilead
Enrollment closed: ARROW: Selonsertib in Adults With Pulmonary Arterial Hypertension (clinicaltrials.gov) - Oct 22, 2015
P2, N=120, Active, not recruiting, Sponsor: Gilead Sciences
Recruiting --> Completed | Trial primary completion date: Apr 2016 --> Dec 2015 Recruiting --> Active, not recruiting
- ||| selonsertib (GS-4997) / Gilead
Enrollment closed: Efficacy, Safety, and Tolerability of Selonsertib (GS-4997) in Participants With Diabetic Kidney Disease (clinicaltrials.gov) - Aug 28, 2015
P2, N=334, Active, not recruiting, Sponsor: Gilead Sciences
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- ||| selonsertib (GS-4997) / Gilead
Enrollment open: Study to Evaluate the Pharmacokinetics of Selonsertib in Participants With Normal and Impaired Hepatic Function (clinicaltrials.gov) - Aug 26, 2015
P1, N=60, Recruiting, Sponsor: Gilead Sciences
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- ||| selonsertib (GS-4997) / Gilead
New P1 trial: Study to Evaluate the Pharmacokinetics of Selonsertib in Participants With Normal and Impaired Hepatic Function (clinicaltrials.gov) - Jul 28, 2015
P1, N=60, Not yet recruiting, Sponsor: Gilead Sciences
- |||| selonsertib (GS-4997) / Gilead, simtuzumab (GS 6624) / Gilead
Enrollment open, Combination therapy: Safety, Tolerability, and Efficacy of GS-4997 Alone or in Combination With Simtuzumab (SIM) in Adults With Nonalcoholic Steatohepatitis (NASH) and Fibrosis Stages F2-F3 (clinicaltrials.gov) - Jul 9, 2015
P2, N=70, Recruiting, Sponsor: Gilead Sciences
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- ||||| selonsertib (GS-4997) / Gilead, simtuzumab (GS 6624) / Gilead
New P2 trial, Combination therapy: Safety, Tolerability, and Efficacy of GS-4997 Alone or in Combination With Simtuzumab (SIM) in Adults With Nonalcoholic Steatohepatitis (NASH) and Fibrosis Stages F2-F3 (clinicaltrials.gov) - Jun 9, 2015
P2, N=70, Not yet recruiting, Sponsor: Gilead Sciences
- |||| selonsertib (GS-4997) / Gilead
Enrollment open: ARROW: Selonsertib in Adults With Pulmonary Arterial Hypertension (clinicaltrials.gov) - Dec 5, 2014
P2, N=120, Recruiting, Sponsor: Gilead Sciences
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- ||||| selonsertib (GS-4997) / Gilead
New P2 trial: ARROW: Selonsertib in Adults With Pulmonary Arterial Hypertension (clinicaltrials.gov) - Sep 9, 2014
P2, N=120, Not yet recruiting, Sponsor: Gilead Sciences
- |||| selonsertib (GS-4997) / Gilead
Enrollment open: Efficacy, Safety, and Tolerability of Selonsertib (GS-4997) in Participants With Diabetic Kidney Disease (clinicaltrials.gov) - Jul 21, 2014
P2, N=300, Recruiting, Sponsor: Gilead Sciences
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- ||||| selonsertib (GS-4997) / Gilead
New P2 trial: Efficacy, Safety, and Tolerability of Selonsertib (GS-4997) in Participants With Diabetic Kidney Disease (clinicaltrials.gov) - Jul 1, 2014
P2, N=300, Not yet recruiting, Sponsor: Gilead Sciences