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

Nonalcoholic Steatohepatitis Clinical Trial

— HERALD  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06342947
• Other study ID #: ALG-055009-303
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: April 1, 2024
• Est. completion date: December 23, 2024

Study information

• Verified date: May 2024
• Source: Aligos Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 23, 2024
• Est. primary completion date: November 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Key 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

Related Conditions & MeSH terms

• Fatty Liver
• NASH
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Steatohepatitis

Intervention

Drug:
• ALG-055009
Softgel Capsule
• Placebo
Softgel Capsule

Locations

Country	Name	City	State
United States	Aligos Clinical Study Site 23	Athens	Georgia
United States	Aligos Clinical Study Site 19	Austin	Texas
United States	Aligos Clinical Study Site 24	Bastrop	Louisiana
United States	Aligos Clinical Study Site 33	Bellaire	Texas
United States	Aligos Clinical Study Site 26	Bradenton	Florida
United States	Aligos Clinical Study Site 27	Brownsville	Texas
United States	Aligos Clinical Study Site 18	Chandler	Arizona
United States	Aligos Clinical Study Site 14	Chesterfield	Michigan
United States	Aligos Clinical Study Site 35	Chula Vista	California
United States	Aligos Clinical Study Site 25	Clearwater	Florida
United States	Aligos Clinical Study Site 21	Columbus	Ohio
United States	Aligos Clinical Study Site 36	East Greenwich	Rhode Island
United States	Aligos Clinical Study Site 28	Edinburg	Texas
United States	Aligos Clinical Study Site 40	Farmers Branch	Texas
United States	Aligos Clinical Study Site 39	Fort Myers	Florida
United States	Aligos Clinical Study Site 5	Houma	Louisiana
United States	Aligos Clinical Study Site 1	Lincoln	California
United States	Aligos Clinical Study Site 29	Louisville	Kentucky
United States	Aligos Clinical Study Site 2	Maitland	Florida
United States	Aligos Clinical Study Site 13	Manassas	Virginia
United States	Aligos Clinical Study Site 4	Marrero	Louisiana
United States	Aligos Clinical Study Site 6	Metairie	Louisiana
United States	Aligos Clinical Study Site 8	Morehead City	North Carolina
United States	Aligos Clinical Study Site 9	Nashville	Tennessee
United States	Aligos Clinical Study Site 7	New York	New York
United States	Aligos Clinical Study Site 22	Ocoee	Florida
United States	Aligos Clinical Study Site 15	Peoria	Arizona
United States	Aligos Clinical Study Site 32	Port Orange	Florida
United States	Aligos Clinical Study Site 37	Poway	California
United States	Aligos Clinical Study Site 10	Rialto	California
United States	Aligos Clinical Study Site 20	San Antonio	Texas
United States	Aligos Clinical Study Site 38	Sarasota	Florida
United States	Aligos Clinical Study Site 34	Seattle	Washington
United States	Aligos Clinical Study Site 31	The Villages	Florida
United States	Aligos Clinical Study Site 12	Topeka	Kansas
United States	Aligos Clinical Study Site 17	Tucson	Arizona
United States	Aligos Clinical Study Site 3	Viera	Florida
United States	Aligos Clinical Study Site 11	Waco	Texas
United States	Aligos Clinical Study Site 16	Westlake	Ohio
United States	Aligos Clinical Study Site 30	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Aligos Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline (absolute/percent) in lipid/lipoprotein levels	Change from baseline (absolute/percent) in lipid/lipoprotein levels at Week 12	12 weeks
Other	Change from baseline (absolute/percent) in SHBG	Change from baseline (absolute/percent) in SHBG	up to 16 weeks
Other	Change from baseline (absolute/percent) alanine aminotransferase (ALT)	Change from baseline (absolute/percent) in alanine aminotransferase (ALT) at Week 12	12 weeks
Other	Change from baseline (absolute/percent) aspartate aminotransferase (AST)	Change from baseline (absolute/percent) in aspartate aminotransferase (AST) at Week 12	12 weeks
Other	Safety and tolerability will be assessed by monitoring TEAEs	Safety and tolerability will be assessed by monitoring TEAEs	16 weeks
Other	Safety and tolerability will be assessed by monitoring 12-lead electrocardiograms (ECGs)	Safety and tolerability will be assessed by monitoring 12-lead electrocardiograms (ECGs)	16 weeks
Other	PK parameters of ALG-055009 in plasma, AUCs	PK parameters of ALG-055009 in plasma, AUCs	12 weeks
Other	PK parameters of ALG-055009 in plasma, Tmax	PK parameters of ALG-055009 in plasma, Tmax	12 weeks
Other	PK parameters of ALG-055009 in plasma, Cmax	PK parameters of ALG-055009 in plasma, Cmax	12 weeks
Other	PK parameters of ALG-055009 in plasma, Cmin	PK parameters of ALG-055009 in plasma, Cmin	12 weeks
Primary	Percent relative change from baseline in liver fat content	Percent relative change from baseline in liver fat content by MRI-PDFF at Week 12	12 weeks
Secondary	Absolute change from baseline in liver fat content	Absolute change from baseline in liver fat content by MRI-PDFF at Week 12	12 weeks
Secondary	Proportion of subjects with =30% relative reduction in liver fat content	Proportion of subjects with =30% relative reduction in liver fat content by MRI-PDFF at Week 12	12 weeks
Secondary	Proportion of subjects with =50% relative reduction in liver fat content	Proportion of subjects with =50% relative reduction in liver fat content by MRI-PDFF at Week 12	12 weeks
Secondary	Proportion of subjects with =70% relative reduction in liver fat content	Proportion of subjects with =70% relative reduction in liver fat content by MRI-PDFF at Week 12	12 weeks
Secondary	Proportion of subjects with normalization (<5%) in liver fat content	Proportion of subjects with normalization (<5%) in liver fat content by MRI-PDFF at Week 12	12 weeks