ALG-055009 in Non-cirrhotic Adults With MASH (HERALD)
- Conditions
- NASHNonalcoholic SteatohepatitisMASHMetabolic Dysfunction-Associated Steatohepatitis
- Interventions
- Drug: Placebo
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 102
-
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
- 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 11
🇺🇸Waco, Texas, United States
Aligos Clinical Study Site 18
🇺🇸Chandler, Arizona, United States
Aligos Clinical Study Site 3
🇺🇸Viera, Florida, United States
Aligos Clinical Study Site 14
🇺🇸Chesterfield, Michigan, United States
Aligos Clinical Study Site 12
🇺🇸Topeka, Kansas, United States
Aligos Clinical Study Site 1
🇺🇸Lincoln, California, United States
Aligos Clinical Study Site 35
🇺🇸Chula Vista, 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 7
🇺🇸New York, New York, United States
Aligos Clinical Study Site 29
🇺🇸Louisville, Kentucky, United States
Aligos Clinical Study Site 23
🇺🇸Athens, Georgia, United States
Aligos Clinical Study Site 19
🇺🇸Austin, Texas, United States
Aligos Clinical Study Site 8
🇺🇸Morehead City, North Carolina, United States
Aligos Clinical Study Site 27
🇺🇸Brownsville, Texas, United States
Aligos Clinical Study Site 28
🇺🇸Edinburg, Texas, United States
Aligos Clinical Study Site 38
🇺🇸Sarasota, Florida, United States
Aligos Clinical Study Site 25
🇺🇸Clearwater, Florida, United States
Aligos Clinical Study Site 20
🇺🇸San Antonio, Texas, United States
Aligos Clinical Study Site 26
🇺🇸Bradenton, Florida, United States
Aligos Clinical Study Site 39
🇺🇸Fort Myers, Florida, United States
Aligos Clinical Study Site 30
🇺🇸Winter Park, Florida, United States
Aligos Clinical Study Site 21
🇺🇸Columbus, Ohio, United States
Aligos Clinical Study Site 34
🇺🇸Seattle, Washington, United States
Aligos Clinical Study Site 9
🇺🇸Nashville, Tennessee, United States
Aligos Clinical Study Site 6
🇺🇸Metairie, Louisiana, United States
Aligos Clinical Study Site 15
🇺🇸Peoria, Arizona, United States
Aligos Clinical Study Site 22
🇺🇸Ocoee, Florida, United States
Aligos Clinical Study Site 31
🇺🇸The Villages, Florida, United States
Aligos Clinical Study Site 24
🇺🇸Bastrop, Louisiana, United States
Aligos Clinical Study Site 4
🇺🇸Marrero, Louisiana, United States
Aligos Clinical Study Site 5
🇺🇸Houma, Louisiana, United States
Aligos Clinical Study Site 32
🇺🇸Port Orange, Florida, United States
Aligos Clinical Study Site 17
🇺🇸Tucson, Arizona, United States
Aligos Clinical Study Site 2
🇺🇸Maitland, Florida, United States
Aligos Clinical Study Site 16
🇺🇸Westlake, Ohio, United States
Aligos Clinical Study Site 36
🇺🇸East Greenwich, Rhode Island, United States
Aligos Clinical Study Site 33
🇺🇸Bellaire, Texas, United States
Aligos Clinical Study Site 40
🇺🇸Farmers Branch, Texas, United States
Aligos Clinical Study Site 13
🇺🇸Manassas, Virginia, United States