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NCT06342947 Clinical Trial

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: Recruiting

Administrative data
NCT number NCT06342947
Other study ID # ALG-055009-303
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date April 1, 2024
Est. completion date December 23, 2024

Study information
Verified date April 2024
Source Aligos Therapeutics
Contact Jen Rito
Phone (800) 466-6059
Email info@aligos.com
Is FDA regulated No
Health authority
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 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

Study Design

Related Conditions & MeSH terms

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
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