Safety, Pharmacokinetics, and Efficacy Signals of Larsucosterol (DUR-928) in Alcohol-Associated Hepatitis.

"CONFLICTS OF INTEREST Guarantor of the article: WeiQi Lin, MD, PhD, and Craig J. McClain, MD. Specific author contributions: C.J.M., V.V., and W.Q.L. drafted the manuscript. T.H., L.S., S.L.F., P.M., and M.C.C. were PI of the study. C.J.M., V.V., M.M., B.B., L.N., G.S., A.M., and S.D. were PI and data analysts of the contemporaneous DASH trial. J.S., C.B., D.S., W.K., J.E.B., and W.Q.L. conceived, designed, and executed the trial. Financial support: DURECT Corporation sponsored larsucosterol phase 2a trial. Funding was provided by the NIH (U01AA026934, U01AA021893-01, and P50AA024337) to C.J.M. Potential competing interests: None to report."

"Financial support: DURECT Corporation sponsored larsucosterol phase 2a trial. Funding was provided by the NIH (U01AA026934, U01AA021893-01, and P50AA024337) to C.J.M."

"The study was conducted in 5 centers in the United States (Southern California Research Center, Piedmont Hospital Transplant Services, Northwestern University Health System, University of Miami, and University of Louisville School of Medicine) and registered at ClinicalTrials.gov, NCT03432260. The protocol was approved by a central Institutional Review Board (IRB) (WCG IRB No. 20180736) and each local IRB. Written informed consent was obtained from each subject or the subject's legal guardian before any undertaking any study-related activity. The trial was conducted and reported in accordance with US FDA guidance, the International Conference on Harmonization Good Clinical Practice, and the provisions of the Declaration of Helsinki."