A Study of BMS-986036 in Subjects With Non-Alcoholic Steatohepatitis (NASH)

Summary

The purpose of this study is to determine whether BMS-986036 is effective in the treatment of subjects with Non-alcoholic Steatohepatitis (NASH).

Timeline

Start

2015-05-08

Primary completion

2017-01-18

Completion

2017-06-19

Outcome

Met primary endpoint

registry BMS-986036 10 mg QD vs Placebo QD; p = 0.0004; Mean Difference (Final Values) -5.43 (90% CI -8.01 to -2.84) NCT02413372 ↗

registry BMS-986036 20 mg QW vs Placebo QD; p = 0.0084; Mean Difference (Final Values) -3.85 (90% CI -6.47 to -1.23) NCT02413372 ↗

Publications

• Sanyal A, Charles ED, Neuschwander-Tetri BA, Loomba R, Harrison SA, Abdelmalek MF, Lawitz EJ, Halegoua-DeMarzio D, Kundu S, Noviello S, Luo Y, Christian R. Pegbelfermin (BMS-986036), a PEGylated fibroblast growth factor 21 analogue, in patients with non-alcoholic steatohepatitis: a randomised, double-blind, placebo-controlled, phase 2a trial. Lancet. 2019 Dec 22;392(10165):2705-2717. doi: 10.1016/S0140-6736(18)31785-9. Epub 2018 Dec 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pegbelfermin	Protein / enzyme biologic	10 mg	Subcutaneous
Subject	Pegbelfermin	Protein / enzyme biologic	20 mg	Subcutaneous

Indications