A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Stage 3 Liver Fibrosis

Summary

This is a study of experimental medication BMS-986036 given to adults with Nonalcoholic Steatohepatitis (NASH; the buildup of fat and inflammation in the liver that is not caused by alcohol) and stage 3 liver fibrosis (severe fibrosis).

Timeline

Start

2018-06-19

Primary completion

2020-09-14

Completion

2021-08-17

Outcome

Missed primary endpoint

paper The FALCON 1 study did not meet its primary endpoint PMID 37088457 ↗

registry analysis (superiority test); BMS-986036 10 mg vs Placebo; p = 0.055 NCT03486899 ↗

Publications

• Loomba R, Sanyal AJ, Nakajima A, Neuschwander-Tetri BA, Goodman ZD, Harrison SA, Lawitz EJ, Gunn N, Imajo K, Ravendhran N, Akahane T, Boone B, Yamaguchi M, Chatterjee A, Tirucherai GS, Shevell DE, Du S, Charles ED, Abdelmalek MF. Pegbelfermin in Patients With Nonalcoholic Steatohepatitis and Stage 3 Fibrosis (FALCON 1): A Randomized Phase 2b Study. Clin Gastroenterol Hepatol. 2024 Jan;22(1):102-112.e9. doi: 10.1016/j.cgh.2023.04.011. Epub 2023 Apr 23.
• Brown EA, Minnich A, Sanyal AJ, Loomba R, Du S, Schwarz J, Ehman RL, Karsdal M, Leeming DJ, Cizza G, Charles ED. Effect of pegbelfermin on NASH and fibrosis-related biomarkers and correlation with histological response in the FALCON 1 trial. JHEP Rep. 2023 Jan 7;5(4):100661. doi: 10.1016/j.jhepr.2022.100661. eCollection 2023 Apr.
• Abdelmalek MF, Charles ED, Sanyal AJ, Harrison SA, Neuschwander-Tetri BA, Goodman Z, Ehman RA, Karsdal M, Nakajima A, Du S, Tirucherai GS, Klinger GH, Mora J, Yamaguchi M, Shevell DE, Loomba R. The FALCON program: Two phase 2b randomized, double-blind, placebo-controlled studies to assess the efficacy and safety of pegbelfermin in the treatment of patients with nonalcoholic steatohepatitis and bridging fibrosis or compensated cirrhosis. Contemp Clin Trials. 2021 May;104:106335. doi: 10.1016/j.cct.2021.106335. Epub 2021 Feb 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pegbelfermin	Protein / enzyme biologic	10 mg	Subcutaneous
Subject	Pegbelfermin	Protein / enzyme biologic	20 mg	Subcutaneous
Subject	Pegbelfermin	Protein / enzyme biologic	40 mg	Subcutaneous

Indications