[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06215716":3,"trial-entities:NCT06215716":3079,"trial-summary:NCT06215716":3083},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":40,"secondary_outcomes":49,"sex":98,"minimum_age":99,"maximum_age":100,"healthy_volunteers":101,"eligibility_criteria":102,"std_ages":116,"locations":119,"central_contacts":3071,"overall_officials":3076,"references":3077,"see_also_links":3078},"NCT06215716","AK-US-001-0105","A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)\u002FMetabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)\u002FMetabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis","RECRUITING","2033-02","2026-08","2026-08-07","2023-12-01","Akero Therapeutics, Inc","INDUSTRY",null,"This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with non-cirrhotic NASH\u002FMASH and fibrosis stage 2 or 3 (F2 or F3).\n\nThe study will enroll subjects in two cohorts for a total samples size of 1650 subjects.","This is a Phase 3, multi-center, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of efruxifermin (EFX) in subjects with non-cirrhotic nonalcoholic steatohepatitis (NASH)\u002Fmetabolic dysfunction-associated steatohepatitis (MASH) and fibrosis stage 2 or 3 (F2 or F3).\n\nApproximately 1,650 subjects will be enrolled into 2 cohorts.\n\nCohort 1 will enroll approximately 750 subjects with biopsy-confirmed NASH\u002FMASH and fibrosis stage F2 or F3. Subjects in Cohort 1 will undergo evaluation of histologic efficacy endpoints at Week 52.\n\nCohort 2 will enroll approximately 900 subjects with biopsy-confirmed fibrosis stage F3. Subjects in Cohort 2 may enroll regardless of NAFLD Activity Score (NAS). Subjects in Cohort 2 will undergo liver biopsy assessment at Week 96.\n\nEligible subjects will be randomized in a 1:1:1 ratio to receive:\n\n* EFX 28 mg administered subcutaneously once weekly\n* EFX 50 mg administered subcutaneously once weekly\n* Placebo administered subcutaneously once weekly\n\nSubjects will participate in:\n\n* a screening period of up to 12 weeks,\n* a 52-week primary histology endpoint treatment period (Cohort 1),\n* a 96-week secondary histology endpoint period (Cohort 2),\n* long-term treatment and clinical outcomes follow-up for up to approximately -240 weeks total treatment duration, and\n* a follow-up visit approximately 30 days after the last dose of study drug.\n\nThe study will evaluate the effects of EFX compared with placebo on histologic improvement in NASH\u002FMASH, fibrosis regression, noninvasive markers of liver fibrosis, biochemistry markers of lipidic and glycemic metabolism, liver-related clinical outcomes, and long-term safety.\n\nClinical outcomes assessments include evaluation of liver-related events and all-cause mortality. Key secondary and long-term outcome assessments include evaluation of fibrosis progression, liver stiffness by FibroScan, and Enhanced Liver Fibrosis (ELF) score at prespecified time points including Weeks 96 and 240.\n\nSubjects who discontinue study drug may continue study assessments according to the protocol schedule to support long-term efficacy and safety evaluations.",[19,20],"NASH With Fibrosis","MASH With Fibrosis",[],"INTERVENTIONAL","TREATMENT",[25],"PHASE3",{"count":27,"type":28},1650,"ESTIMATED",[30,37],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DRUG","Efruxifermin","Administered by subcutaneous injection",[35,36],"EFX 28 mg","EFX 50 mg",{"type":31,"name":38,"description":33,"armGroupLabels":39},"Placebo",[38],[41,45],{"measure":42,"description":43,"timeFrame":44},"Cohort 1 Only: Resolution of NASH\u002FMASH and a ≥ 1 stage improvement in fibrosis","Based on NAS (scored by 0-3 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 = perisinusoidal or periportal fibrosis, 2 = perisinusoidal and portal\u002Fperiportal fibrosis, 3 = bridging fibrosis, 4 = cirrhosis)","52 Weeks",{"measure":46,"description":47,"timeFrame":48},"Event-free survival","Based on time from randomization to the first clinical event including evidence of disease progression, liver decompensation events, liver transplantation or eligibility for liver transplantation, and all-cause mortality.","240 Weeks",[50,52,54,57,60,63,66,69,70,74,77,80,83,86,88,90,92,94,96],{"measure":51,"description":43,"timeFrame":44},"Cohort 1 Only: Resolution of NASH\u002FMASH and no worsening of fibrosis",{"measure":53,"description":43,"timeFrame":44},"Cohort 1 Only: ≥ 1 stage improvement in fibrosis and no worsening of steatohepatitis",{"measure":55,"description":56,"timeFrame":44},"Change from baseline of non-invasive markers of liver fibrosis: ELF score","The ELF score measures the severity of liver fibrosis and estimates the risk of disease progression to cirrhosis or liver-related events, with higher scores indicating higher liver fibrosis level and higher risk of disease progression.",{"measure":58,"description":59,"timeFrame":44},"Change from baseline of non-invasive markers of liver fibrosis: ELF score components (TIMP-1, HA, PIIINP, Pro-C3)","Tissue inhibitor of metalloproteinase-1 \\[TIMP-1\\], hyaluronic acid \\[HA\\], amino terminal pro-peptide of type 3 procollagen \\[PIIINP\\]), and propeptide of type 3 procollagen (Pro-C3)",{"measure":61,"description":56,"timeFrame":62},"Change from baseline in non-invasive markers of liver fibrosis: ELF score","96 Weeks, 240 Weeks",{"measure":64,"description":56,"timeFrame":65},"Change from baseline in non-invasive markers of liver fibrosis: ELF score components: TIMP-1, HA, PIIINP, Pro-C3","Week 240",{"measure":67,"description":68,"timeFrame":44},"Change from baseline of non-invasive markers of liver fibrosis: Fibroscan","Liver stiffness assessed by transient elastography (FibroScan)",{"measure":67,"description":68,"timeFrame":62},{"measure":71,"description":72,"timeFrame":73},"Change from baseline of markers of liver injury: ALT, AST, GGT","ALT (U\u002FL), AST (U\u002FL), GGT (U\u002FL)","52 Weeks, 240 Weeks",{"measure":75,"description":76,"timeFrame":73},"Change from baseline of markers of liver injury: Uric Acid","Uric acid (mg\u002FdL)",{"measure":78,"description":79,"timeFrame":73},"Change from baseline of lipoproteins: Total cholesterol, TG, Non-HDL-C, HDL-C, and LDL-C","Total cholesterol (mg\u002FdL), TG (mg\u002FdL), Non-HDL-C (mg\u002FdL), HDL-C (mg\u002FdL), and LDL-C (mg\u002FdL)",{"measure":81,"description":82,"timeFrame":73},"Change from baseline of markers of insulin sensitivity and glycemic control: HbA1c","HbA1c (%)",{"measure":84,"description":85,"timeFrame":73},"Change from baseline of markers of insulin sensitivity and glycemic control: Adiponectin","Adiponectin (mg\u002FL)",{"measure":87,"timeFrame":73},"Change from baseline of body weight (kg)",{"measure":89,"timeFrame":73},"To assess the safety and tolerability of EFX through the reporting of extent of exposure (weeks)",{"measure":91,"timeFrame":73},"To assess the safety and tolerability of EFX through the reporting of adverse events (severity of events)",{"measure":93,"timeFrame":73},"To assess the safety and tolerability of EFX through the reporting of adverse events (frequency of events)",{"measure":95,"timeFrame":73},"To assess the safety and tolerability of EFX through the reporting of abnormal clinical laboratory tests, ECGs, ultrasounds, vital sign assessments (number of patients)",{"measure":97,"timeFrame":73},"To assess the immunogenicity of EFX through the reporting of antidrug antibodies (number of patients)","ALL","18 Years","80 Years",false,{"inclusion":103,"exclusion":111,"raw_text":115},[104,105,106,107,108,109,110],"Males and non-pregnant, non-lactating females between 18 - 80 years of age inclusive, based on the date of the screening visit.","Previous history or presence of 2 out of 4 components of metabolic syndrome (obesity, dyslipidemia, elevated blood pressure, elevated fasting glucose) or type 2 diabetes.","Cohort 1: Biopsy-proven NASH\u002FMASH. Must have had a liver biopsy obtained ≤ 180 days prior to screening with fibrosis stage 2 or 3 and a non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of ≥ 4 with at least a score of 1 in each of the following NAS components:","Steatosis (scored 0 to 3),","Ballooning degeneration (scored 0 to 2), and","Lobular inflammation (scored 0 to 3).","Cohort 2: Biopsy-proven fibrosis stage 3. Must have had a liver biopsy obtained ≤ 180 days prior to screening. Subjects with NAS \\\u003C4 may be enrolled and are not required to meet 1 point in each of the components of NAS.",[112,113,114],"Other causes of liver disease based on medical history and\u002For liver histology and\u002For central laboratory results.","Presence of cirrhosis on liver biopsy (fibrosis stage 4).","Type 1 or uncontrolled Type 2 diabetes.","Inclusion Criteria:\n\n* Males and non-pregnant, non-lactating females between 18 - 80 years of age inclusive, based on the date of the screening visit.\n* Previous history or presence of 2 out of 4 components of metabolic syndrome (obesity, dyslipidemia, elevated blood pressure, elevated fasting glucose) or type 2 diabetes.\n* Cohort 1: Biopsy-proven NASH\u002FMASH. Must have had a liver biopsy obtained ≤ 180 days prior to screening with fibrosis stage 2 or 3 and a non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of ≥ 4 with at least a score of 1 in each of the following NAS components:\n\n  * Steatosis (scored 0 to 3),\n  * Ballooning degeneration (scored 0 to 2), and\n  * Lobular inflammation (scored 0 to 3).\n* Cohort 2: Biopsy-proven fibrosis stage 3. Must have had a liver biopsy obtained ≤ 180 days prior to screening. Subjects with NAS \\\u003C4 may be enrolled and are not required to meet 1 point in each of the components of NAS.\n\nExclusion Criteria:\n\n* Other causes of liver disease based on medical history and\u002For liver histology and\u002For central laboratory results.\n* Presence of cirrhosis on liver biopsy (fibrosis stage 4).\n* Type 1 or uncontrolled Type 2 diabetes.\n\nOther inclusion and exclusion criteria may 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