Study of Aldafermin (NGM282) in Subjects With Compensated Cirrhosis (ALPINE 4)

Summary

A multi-center evaluation of aldafermin in a randomized, double-blind, placebo-controlled study in subjects with compensated cirrhosis.

Timeline

Start

2020-03-23

Primary completion

2023-01-04

Completion

2023-02-23

Outcome

Met primary endpoint

paper Aldafermin 3 mg resulted in a significant reduction in Enhanced Liver Fibrosis in patients with compensated NASH cirrhosis. PMID 37732990 ↗

release “Phase 2b ALPINE 4 trial met its primary endpoint, demonstrating a statistically significant improvement in Enhanced Liver Fibrosis (ELF) score at 48 weeks versus baseline” ngmbio.com ↗

release “As previously reported, the ALPINE 4 study met its primary endpoint, with aldafermin 3 mg demonstrating a statistically significant reduction” ngmbio.com ↗

release “Announced topline positive data from Phase 2b ALPINE 4 trial of aldafermin; study met its primary endpoint” ngmbio.com ↗

Publications

• Rinella ME, Lieu HD, Kowdley KV, Goodman ZD, Alkhouri N, Lawitz E, Ratziu V, Abdelmalek MF, Wong VW, Younes ZH, Sheikh AM, Brannan D, Freilich B, Membreno F, Sinclair M, Melchor-Khan L, Sanyal AJ, Ling L, Harrison SA. A randomized, double-blind, placebo-controlled trial of aldafermin in patients with NASH and compensated cirrhosis. Hepatology. 2024 Mar 1;79(3):674-689. doi: 10.1097/HEP.0000000000000607. Epub 2023 Sep 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aldafermin	Protein / enzyme biologic	0.3 mg	Subcutaneous
Subject	Aldafermin	Protein / enzyme biologic	1 mg	Subcutaneous
Subject	Aldafermin	Protein / enzyme biologic	3 mg	Subcutaneous

Indications