A Study Evaluating Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH
NCT Number: NCT06528314
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: NASH - Nonalcoholic Steatohepatitis|MASH - Metabolic Dysfunction-Associated Steatohepatitis
Interventions: DRUG: Efruxifermin|DRUG: Placebo
Sponsor: Akero Therapeutics, Inc
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1150
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-10
Completion Date: 2029-10
Locations: Akero Clinical Study Site, Birmingham, Alabama, 35209, United States|Akero Clinical Study Site, Tucson, Arizona, 85712, United States|Akero Clinical Study Site, Tucson, Arizona, 85715, United States|Akero Clinical Study Site, North Little Rock, Arkansas, 72117, United States|Akero Clinical Study Site, Pasadena, California, 91105, United States|Akero Clinical Study Site, Hialeah Gardens, Florida, 33016, United States|Akero Clinical Study Site, Lakewood Ranch, Florida, 34211, United States|Akero Clinical Study Site, Naples, Florida, 34102, United States|Akero Clinical Study Site, Ocala, Florida, 34471, United States|Akero Clinical Study Site, Venice, Florida, 34285, United States|Akero Clinical Study Site, Gainesville, Georgia, 30501, United States|Akero Clinical Study Site, Marietta, Georgia, 30060, United States|Akero Clinical Study Site, South Bend, Indiana, 46635, United States|Akero Clinical Study Site, Topeka, Kansas, 66606, United States|Akero Clinical Study Site, Covington, Louisiana, 70433, United States|Akero Clinical Study Site, Houma, Louisiana, 70363, United States|Akero Clinical Study Site, Marrero, Louisiana, 70072, United States|Akero Clinical Study Site, Metairie, Louisiana, 70006, United States|Akero Clinical Study Site, Shreveport, Louisiana, 71105, United States|Akero Clinical Study Site, Baltimore, Maryland, 21202, United States|Akero Clinical Study Site, Columbia, Missouri, 65201, United States|Akero Clinical Study Site, Kansas City, Missouri, 64131, United States|Akero Clinical Study Site, Las Vegas, Nevada, 89106, United States|Akero Clinical Study Site, Sparta, New Jersey, 07871, United States|Akero Clinical Study Site, Statesville, North Carolina, 28625, United States|Akero Clinical Study Site, Springboro, Ohio, 45066, United States|Akero Clinical Study Site, Westlake, Ohio, 44145, United States|Akero Clinical Study Site, Columbia, South Carolina, 29204, United States|Akero Clinical Study Site, Hermitage, Tennessee, 37076, United States|Akero Clinical Study Site, Austin, Texas, 78745, United States|Akero Clinical Study Site, Austin, Texas, 78757, United States|Akero Clinical Study Site, Brownsville, Texas, 78520, United States|Akero Clinical Study Site, Dallas, Texas, 75234, United States|Akero Clinical Study Site, Edinburg, Texas, 78539, United States|Akero Clinical Study Site, San Antonio, Texas, 78222, United States|Akero Clinical Study Site, San Antonio, Texas, 78229, United States|Akero Clinical Study Site, Wichita Falls, Texas, 76301, United States|Akero Clinical Study Site, Richmond, Virginia, 23236, United States|Akero Clinical Study Site, Roanoke, Virginia, 24014, United States|Akero Clinical Study Site, San Juan, 00927, Puerto Rico

Summary:
This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with compensated cirrhosis due to NASH/MASH.

Primary Outcome Measures: Time from randomization to first occurrence of disease progression as measured by composite of protocol-specified clinical events, 5 years|Cohort 1 only: ≥ 1 stage improvement in fibrosis and no worsening of steatohepatitis, Based on NASH CRN fibrosis score (scored by a fibrosis score of 0-4, where 0 = no fibrosis, 1 = centrilobular pericellular fibrosis, 2 = centrilobular and periportal fibrosis, 3 = bridging fibrosis, 4 = cirrhosis), 96 Weeks
Secondary Outcome Measures: Change from baseline of non-invasive markers of liver fibrosis, ELF (scale of 6.7 to 11.3 with higher scores indicative of increased fibrosis), 96 Weeks|Change from baseline of non-invasive markers of liver fibrosis, Pro-C3 (ug/L), 96 Weeks|Change from baseline of non-invasive markers of liver fibrosis, Liver stiffness assessed by transient elastography (FibroScan®) (kPa), 96 Weeks|Change from baseline of non-invasive markers of liver fibrosis, FAST score (varied on a scale from 0 to 1, with the patients being classified as having low \[\<0.35\], intermediate \[0.35-0.67\], or higher \[\>0.67\] probability of having significant inflammatory activity and fibrosis), 96 Weeks|Change from baseline of markers of liver injury, ALT (U/L) and AST (U/L), 96 Weeks|Change from baseline of lipoproteins, Total cholesterol (mg/dL), Triglycerides (mg/dL), HDL-C (mg/dL), Non-HDL-C (mg/dL), and LDL-C (mg/dL), 96 Weeks|Change from baseline of markers of insulin sensitivity and glycemic control, HbA1c (%), 96 Weeks|Change from baseline of markers of insulin sensitivity and glycemic control, C-Peptide (ng/mL), 96 Weeks|Change from baseline of markers of insulin sensitivity and glycemic control, Adiponectin (mg/L), 96 Weeks|Change from baseline of markers of insulin sensitivity and glycemic control, Insulin (mIU/L), 96 Weeks|Change from baseline of markers of insulin sensitivity and glycemic control, HOMA-IR (≥ 2.5 indicates insulin resistance), 96 Weeks|Change from baseline of body weight (kg), 96 Weeks|To assess the safety and tolerability of EFX through the reporting of extent of exposure (weeks), 96 Weeks|To assess the safety and tolerability of EFX through the reporting of adverse events (frequency of events), 96 Weeks|To assess the safety and tolerability of EFX through the reporting of adverse events (severity of events), 96 Weeks|Number of participants with abnormal laboratory tests results, abnormal ECGs, abnormal ultrasounds, abnormal vital sign assessments, 96 Weeks|Cohort 1 only: ≥ 1 stage improvement in fibrosis and no worsening of steatohepatitis, Based on NASH CRN fibrosis score (scored by a fibrosis score of 0-4, where 0 = no fibrosis, 1 = centrilobular pericellular fibrosis, 2 = centrilobular and periportal fibrosis, 3 = bridging fibrosis, 4 = cirrhosis), 5 Years|Cohort 1 only: ≥ 1 stage improvement in fibrosis, Based on NASH CRN fibrosis score (scored by a fibrosis score of 0-4, where 0 = no fibrosis, 1 = centrilobular pericellular fibrosis, 2 = centrilobular and periportal fibrosis, 3 = bridging fibrosis, 4 = cirrhosis), 96 Weeks, 5 Years|Cohort 1 only: Resolution of NASH/MASH, Based on NAS (scored by 0-1 for steatosis, 0-3 for inflammation, and 0-2 for ballooning), 96 Weeks, 5 Years|Cohort 1 only: Resolution of NASH/MASH and a ≥ 1 stage improvement in fibrosis, Based on NAS (scored by 0-1 for steatosis, 0-3 for inflammation, and 0-2 for ballooning) and NASH CRN fibrosis score (scored by a fibrosis score of 0-4, where 0 = no fibrosis, 1 = centrilobular pericellular fibrosis, 2 = centrilobular and periportal fibrosis, 3 = bridging fibrosis, 4 = cirrhosis), 96 Weeks, 5 Years