Study of Safety and Efficacy of Tropifexor (LJN452) in Patients With Non-alcoholic Steatohepatitis (NASH)

Summary

The purpose of the study was to assess the effects of different doses of tropifexor (LJN452) with respect to safety, tolerability, and on markers of liver inflammation in patients with NASH

Timeline

Start

2016-08-01

Primary completion

2020-04-06

Completion

2020-04-06

Publications

• Sanyal AJ, Lopez P, Lawitz EJ, Lucas KJ, Loeffler J, Kim W, Goh GBB, Huang JF, Serra C, Andreone P, Chen YC, Hsia SH, Ratziu V, Aizenberg D, Tobita H, Sheikh AM, Vierling JM, Kim YJ, Hyogo H, Tai D, Goodman Z, Schaefer F, Carbarns IRI, Lamle S, Martic M, Naoumov NV, Brass CA. Tropifexor for nonalcoholic steatohepatitis: an adaptive, randomized, placebo-controlled phase 2a/b trial. Nat Med. 2023 Feb;29(2):392-400. doi: 10.1038/s41591-022-02200-8. Epub 2023 Feb 16.
• Naoumov NV, Brees D, Loeffler J, Chng E, Ren Y, Lopez P, Tai D, Lamle S, Sanyal AJ. Digital pathology with artificial intelligence analyses provides greater insights into treatment-induced fibrosis regression in NASH. J Hepatol. 2022 Nov;77(5):1399-1409. doi: 10.1016/j.jhep.2022.06.018. Epub 2022 Jun 30.

Drugs

Indications