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
The Lancet Dec 19, 2018
Sanyal A, et al. - Researchers evaluated the safety and efficacy of pegbelfermin in patients with non-alcoholic steatohepatitis in this multicentre, randomized, double-blind, placebo-controlled, parallel-group, phase 2a study. At 17 medical centers in the USA, enrollment of patients was done. Eligible patients were stratified by type 2 diabetes status and were randomly assigned (1:1:1) by a computer-based system to receive subcutaneous injections of placebo once a day, 10 mg pegbelfermin once a day, or 20 mg pegbelfermin once a week, all for 16 weeks. Patients with non-alcoholic steatohepatitis generally well tolerated the treatment with subcutaneously administered pegbelfermin for 16 weeks and displayed a significant reduction in hepatic fat fraction.
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