AURORA: A Study for the Efficacy and Safety of Cenicriviroc (CVC) for the Treatment of Liver Fibrosis in Adults With Nonalcoholic Steatohepatitis (NASH)

Phase 3 Terminated 1778 enrolled Tobira Therapeutics, Inc.

RandomizedParallel-groupDouble-blindTreatment

Summary

The AURORA study will be conducted to confirm the efficacy and safety of cenicriviroc (CVC) for the treatment of liver fibrosis in adult participants with NASH.

Timeline

Start: 2017-04-05
Primary completion: 2021-01-12
Completion: 2021-03-09

Outcome

Missed primary endpoint

Stopped: “This study was terminated early due to lack of efficacy based on the results of the planned interim analysis of Part 1 data.”

paper the primary endpoint (22.3% vs 25.5%; odds ratio, 0.84; 95% confidence interval, 0.63-1.10; P = .21) PMID 37061109 ↗

paper Cenicriviroc Lacked Efficacy to Treat Liver Fibrosis in Nonalcoholic Steatohepatitis PMID 37061109 ↗

paper This study did not demonstrate the efficacy of CVC for treating liver fibrosis assessed by histology in adults with NASH PMID 37061109 ↗

Publications

Anstee QM, Neuschwander-Tetri BA, Wai-Sun Wong V, Abdelmalek MF, Rodriguez-Araujo G, Landgren H, Park GS, Bedossa P, Alkhouri N, Tacke F, Sanyal AJ. Cenicriviroc Lacked Efficacy to Treat Liver Fibrosis in Nonalcoholic Steatohepatitis: AURORA Phase III Randomized Study. Clin Gastroenterol Hepatol. 2024 Jan;22(1):124-134.e1. doi: 10.1016/j.cgh.2023.04.003. Epub 2023 Apr 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cenicriviroc	Small molecule	150 mg	Oral