NCT06342947

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

A Randomized, Double-Blind, Placebo-Controlled Phase 2a Study Evaluating the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of ALG-055009 in Non-Cirrhotic Adults With Metabolic Dysfunction-Associated Steatohepatitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Aligos Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a double-blind, randomized, placebo-controlled 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. The study will be conducted in approximately 100 adult non-cirrhotic subjects with presumed MASH and liver fibrosis (F1-F3). The study will be conducted at up to approximately 45 sites throughout the United States of America.

Conditions

• NASH
• MASH
• Metabolic Dysfunction-Associated Steatohepatitis
• Nonalcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	ALG-055009	Softgel Capsule
DRUG	Placebo	Softgel Capsule

Timeline

• Start date: 2024-04-01
• Primary completion: 2024-08-19
• Completion: 2024-09-09
• First posted: 2024-04-02
• Last updated: 2025-02-17

Locations

40 sites across 1 country: United States

Regulatory

• FDA-regulated drug study