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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
102
Softgel Capsule
Softgel Capsule
Percent relative change from baseline in liver fat content
Percent relative change from baseline in liver fat content by MRI-PDFF at Week 12
Time frame: 12 weeks
Absolute change from baseline in liver fat content
Absolute change from baseline in liver fat content by MRI-PDFF at Week 12
Time frame: 12 weeks
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
Time frame: 12 weeks
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
Time frame: 12 weeks
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
Time frame: 12 weeks
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
Time frame: 12 weeks
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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
...and 30 more locations