Evaluation of Efficacy, Safety and Tolerability of Aldafermin in a Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study In Subjects With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis (ALPINE 2/3)

Summary

This is a multi-center evaluation of NGM282 in a randomized, double-blind, placebo-controlled study administered for 24 weeks in participants with histologically confirmed NASH and F2/F3 Fibrosis.

Timeline

Start

2019-05-16

Primary completion

2021-03-04

Completion

2021-03-29

Outcome

Missed primary endpoint

paper Aldafermin was generally well tolerated but did not produce a significant dose response on fibrosis improvement of at least one stage with no worsening of NASH PMID 35325622 ↗

release “following the announcement that the ALPINE 2/3 Phase 2b trial of aldafermin in F2/F3 NASH did not meet its primary endpoint” ngmbio.com ↗

Publications

• Harrison SA, Abdelmalek MF, Neff G, Gunn N, Guy CD, Alkhouri N, Bashir MR, Freilich B, Kohli A, Khazanchi A, Sheikh MY, Leibowitz M, Rinella ME, Siddiqui MS, Kipnes M, Moussa SE, Younes ZH, Bansal M, Baum SJ, Borg B, Ruane PJ, Thuluvath PJ, Gottwald M, Khan M, Chen C, Melchor-Khan L, Chang W, DePaoli AM, Ling L, Lieu HD. Aldafermin in patients with non-alcoholic steatohepatitis (ALPINE 2/3): a randomised, double-blind, placebo-controlled, phase 2b trial. Lancet Gastroenterol Hepatol. 2022 Jul;7(7):603-616. doi: 10.1016/S2468-1253(22)00017-6. Epub 2022 Mar 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