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

Phase 2

Completed

• Conditions: NASH; Nonalcoholic Steatohepatitis; MASH; Metabolic Dysfunction-Associated Steatohepatitis
• Interventions: Drug: Placebo; Drug: ALG-055009

• Registration Number: NCT06342947
• Lead Sponsor: Aligos Therapeutics

Brief 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.

Study Timeline

• Study First Submitted: 2024-03-15
• Study First Submitted QC: 2024-03-26
• Study Start: 2024-04-01
• Study First Posted: 2024-04-02
• Primary Completion: 2024-08-19
• Study Completion: 2024-09-09
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• Male or female, 18 to 75 years of age

• Body mass index (BMI) ≥ 25 kg/m2

• Diagnosis of presumed NASH/MASH with F1-F3 liver fibrosis based on one of the following:

  • Liver biopsy within 6 months prior to screening showing a NAFLD activity score (NAS) of ≥4 with at least a score of 1 in each of the NAS components; OR
  • Having ≥2 metabolic syndrome criteria and a screening FibroScan liver stiffness measurement between 7 - 20 kPa

• Screening FibroScan with CAP score of >300 dB/m

• Screening MRI-PDFF with ≥10% liver fat content

Key

Exclusion Criteria

• History or clinical evidence of chronic liver disease other than metabolic dysfunction-associated steatotic liver disease (MASLD)
• History or current evidence of cirrhosis
• History of liver transplantation or known planned liver transplantation
• History or current evidence of a pituitary disorder or hyperthyroidism
• Untreated clinical or subclinical hypothyroidism; or on thyroid replacement therapy at screening or within the last 6 months prior to screening.
• TSH, free T4, or Total T3 >1.1 x ULN or <0.9 x LLN
• Clinically concerning abnormal ECG or cardiac history
• HbA1c ≥9.5%
• Platelet count ≤135,000/mm3
• ALT or AST >5 x ULN
• INR >1.3
• Albumin <3.5 g/dL
• eGFR <45 mL/min/1.73 m2

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo softgel capsule Daily for 12 weeks
ALG-055009 softgel capsule 0.5mg	ALG-055009	ALG-055009 softgel capsule 0.5mg Daily for 12 weeks
ALG-055009 softgel capsule 0.3mg	ALG-055009	ALG-055009 softgel capsule 0.3mg Daily for 12 weeks
ALG-055009 softgel capsule 0.9mg	ALG-055009	ALG-055009 softgel capsule 0.9mg Daily for 12 weeks
ALG-055009 softgel capsule 0.7mg	ALG-055009	ALG-055009 softgel capsule 0.7mg Daily for 12 weeks

Primary Outcome Measures

Name	Time	Method
Percent relative change from baseline in liver fat content	12 weeks	Percent relative change from baseline in liver fat content by MRI-PDFF at Week 12

Secondary Outcome Measures

Name	Time	Method
Absolute change from baseline in liver fat content	12 weeks	Absolute change from baseline in liver fat content by MRI-PDFF at Week 12
Proportion of subjects with ≥30% relative reduction in liver fat content	12 weeks	Proportion of subjects with ≥30% relative reduction in liver fat content by MRI-PDFF at Week 12
Proportion of subjects with normalization (<5%) in liver fat content	12 weeks	Proportion of subjects with normalization (\<5%) in liver fat content by MRI-PDFF at Week 12
Proportion of subjects with ≥50% relative reduction in liver fat content	12 weeks	Proportion of subjects with ≥50% relative reduction in liver fat content by MRI-PDFF at Week 12
Proportion of subjects with ≥70% relative reduction in liver fat content	12 weeks	Proportion of subjects with ≥70% relative reduction in liver fat content by MRI-PDFF at Week 12

Trial Locations

Locations (40)

Aligos Clinical Study Site 18; 🇺🇸 Chandler, Arizona, United States

Aligos Clinical Study Site 15; 🇺🇸 Peoria, Arizona, United States

Aligos Clinical Study Site 17; 🇺🇸 Tucson, Arizona, United States

Aligos Clinical Study Site 35; 🇺🇸 Chula Vista, California, United States

Aligos Clinical Study Site 1; 🇺🇸 Lincoln, California, United States

Aligos Clinical Study Site 37; 🇺🇸 Poway, California, United States

Aligos Clinical Study Site 10; 🇺🇸 Rialto, California, United States

Aligos Clinical Study Site 26; 🇺🇸 Bradenton, Florida, United States

Aligos Clinical Study Site 25; 🇺🇸 Clearwater, Florida, United States

Aligos Clinical Study Site 39; 🇺🇸 Fort Myers, Florida, United States

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