ALG-055009 in Non-cirrhotic Adults With MASH (HERALD)

Summary

This is a Phase 2a study to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of oral (PO) daily (QD) doses of ALG-055009 (soft gelatin \[softgel\] capsule) for 12 weeks.

Timeline

Start

2024-04-01

Primary completion

2024-08-19

Completion

2024-09-09

Outcome

Met primary endpoint

release “Topline HERALD data were presented in September 2024, demonstrating that ALG-055009 dose groups met the primary endpoint” aligos.com ↗

release “HERALD data were presented at APASL 2025, demonstrating that ALG-055009 dose groups met the primary endpoint with statistically significant reductions in liver fat” aligos.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ALG-055009	Unknown	0.3 mg	Oral
Subject	ALG-055009	Unknown	0.5 mg	Oral
Subject	ALG-055009	Unknown	0.7 mg	Oral
Subject	ALG-055009	Unknown	0.9 mg	Oral

Indications