> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-evaluating-efruxifermin-in-subjects-with-compensated-863d698c-5b75-4aff-a008-6fde4c57e97a > Record changed: 2026-10-13 # A Study Evaluating Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH NCT06528314 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06528314) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06528314) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06528314) Participants 2,150 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06528314) Lead sponsor Akero Therapeutics, Inc Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06528314) Start date 2024-09-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06528314) Number of sites 329 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06528314) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06528314) **Short title** A Study Evaluating Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06528314) **Official title** A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06528314) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06528314) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06528314) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06528314) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06528314) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06528314) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06528314) ## Dates **Completion date** 2030-03-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06528314) **First posted** 2024-07-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06528314) **Registry last updated** 2026-08-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06528314) **Primary completion date** 2030-02-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06528314) **Start date** 2024-09-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06528314) ## Size and sites **Participants** 2,150 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06528314) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06528314) **Planned participants** 2,150 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06528314) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06528314) **Number of sites** 329 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06528314) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06528314) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06528314) **Lead sponsor** Akero Therapeutics, Inc Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06528314) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06528314) ## Identifiers **Registry ID** NCT06528314 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06528314) **ClinicalTrials.gov ID** NCT06528314 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06528314) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06528314) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06528314) ## Outcomes ### Primary outcomes 1. Time from randomization to the first significant clinical event including disease progression, liver decompensation events, etc. Timeframe: 5 years Measured by composite of protocol-specified clinical events 2. Cohort 1 only: Proportion of subjects with ≥ 1 stage improvement in fibrosis and no worsening of steatohepatitis Timeframe: 96 Weeks 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) ### Secondary outcomes 1. Change from baseline of non-invasive markers of liver fibrosis Timeframe: 96 Weeks, 5 Years ELF (scale of 6.7 to 11.3 with higher scores indicative of increased fibrosis) 2. Change from baseline of non-invasive markers of liver fibrosis Timeframe: 96 Weeks, 5 Years Pro-C3 (ug/L) 3. Change from baseline of non-invasive markers of liver fibrosis Timeframe: 96 Weeks, 5 Years Liver stiffness assessed by transient elastography (FibroScan®) (kPa) 4. Change from baseline of markers of liver injury Timeframe: 96 Weeks, 5 Years ALT (U/L) and AST (U/L) 5. Change from baseline of lipoproteins Timeframe: 96 Weeks, 5 Years Total cholesterol (mg/dL), Triglycerides (mg/dL), HDL-C (mg/dL), Non-HDL-C (mg/dL), and LDL-C (mg/dL) 6. Change from baseline of markers of insulin sensitivity and glycemic control Timeframe: 96 Weeks, 5 Years HbA1c (%) 7. Change from baseline of markers of insulin sensitivity and glycemic control Timeframe: 96 Weeks, 5 Years C-Peptide (ng/mL) 8. Change from baseline of markers of insulin sensitivity and glycemic control Timeframe: 96 Weeks, 5 Years Adiponectin (mg/L) 9. Change from baseline of markers of insulin sensitivity and glycemic control Timeframe: 96 Weeks, 5 Years Insulin (mIU/L) 10. Change from baseline of markers of insulin sensitivity and glycemic control Timeframe: 96 Weeks, 5 Years HOMA-IR (≥ 2.5 indicates insulin resistance) 11. Change from baseline of body weight (kg) Timeframe: 96 Weeks, 5 Years 12. Safety and tolerability of EFX through the reporting of extent of exposure (weeks) Timeframe: From first dose through end of study (up to 5 Years) 13. Safety and tolerability of EFX through the reporting of adverse events (frequency of events) Timeframe: From first dose through end of study (up to 5 Years) Proportion of subjects reporting adverse events 14. Safety and tolerability of EFX through the reporting of adverse events (severity of events) Timeframe: From first dose through end of study (up to 5 Years) Proportion of subjects reporting adverse events 15. Number of participants with abnormal laboratory tests results, abnormal ECGs, abnormal ultrasounds, abnormal vital sign assessments Timeframe: From first dose through end of study (up to 5 years) 16. Cohort 1 only: Proportion of subjects with ≥ 1 stage improvement in fibrosis and no worsening of steatohepatitis Timeframe: 5 Years 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) 17. Cohort 1 only: Proportion of subjects with ≥ 1 stage improvement in fibrosis Timeframe: 96 Weeks 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) 18. Cohort 1 only: Proportion of subjects with Resolution of NASH/MASH Timeframe: 96 Weeks Based on NAS (scored by 0-1 for steatosis, 0-3 for inflammation, and 0-2 for ballooning) 19. Cohort 1 only: Proportion of subjects with Resolution of NASH/MASH and a ≥ 1 stage improvement in fibrosis Timeframe: 96 Weeks 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) Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06528314) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 80 Years **Healthy volunteers** No ### Inclusion criteria - Cohort 1: Biopsy proven compensated cirrhosis (fibrosis stage 4) due to NASH/MASH and NAS score of >=3 (at least 1 in each category) or evidence of steatosis and 2 current features of metabolic comorbidities - Cohort 2: Biopsy proven or non-invasively diagnosed compensated cirrhosis (fibrosis stage 4) due to NASH/MASH ### Exclusion criteria - Other causes of liver disease based on medical history and/or liver histology and/or central laboratory results - Type 1 diabetes or unstable Type 2 diabetes - Any current or prior history of decompensated liver disease Other inclusion and exclusion criteria may apply. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06528314) ## Sites - Akero Clinical Study SiteBirmingham, United StatesRecruiting - Akero Clinical Study SiteDothan, United StatesRecruiting - Akero Clinical Study SiteChandler, United StatesRecruiting - Akero Clinical Study SiteFlagstaff, United StatesCompleted - Akero Clinical Study SitePeoria, United StatesRecruiting - Akero Clinical Study SiteScottsdale, United StatesRecruiting - Akero Clinical Study SiteTucson, United StatesRecruiting - Akero Clinical Study SiteTucson, United StatesRecruiting - Akero Clinical Study SiteTucson, United StatesRecruiting - Akero Clinical Study SiteTucson, United StatesRecruiting - Akero Clinical Study SiteConway, United StatesCompleted - Akero Clinical Study SiteJonesboro, United StatesCompleted - Akero Clinical Study SiteLittle Rock, United StatesRecruiting - Akero Clinical Study SiteNorth Little Rock, United StatesRecruiting - Akero Clinical Study SiteCoronado, United StatesRecruiting - Akero Clinical Study SiteEscondido, United StatesRecruiting - Akero Clinical Study SiteFolsom, United StatesRecruiting - Akero Clinical Study SiteFountain Valley, United StatesRecruiting - Akero Clinical Study SiteLancaster, United StatesRecruiting - Akero Clinical Study SiteLong Beach, United StatesRecruiting - Akero Clinical Study SiteLos Angeles, United StatesRecruiting - Akero Clinical Study SiteNewport Beach, United StatesRecruiting - Akero Clinical Study SiteOrange, United StatesRecruiting - Akero Clinical Study SitePasadena, United StatesRecruiting - Akero Clinical Study SiteRedwood City, United StatesRecruiting And 304 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06528314) ## Related records ### Drugs (1) - [Efruxifermin](https://trialight.com/data/asset/efruxifermin-92f34399-5e95-4620-8063-37948c46eee4.md) ### Lead sponsors (1) - [Akero Therapeutics, Inc](https://trialight.com/data/company/akero-therapeutics-inc-02a38301-a336-4896-bb8d-f39c69f7808e.md) ### Conditions (2) - [Metabolic dysfunction-associated steatohepatitis](https://trialight.com/data/condition/metabolic-dysfunction-associated-steatohepatitis-05fad825-0fff-55c9-8746-0cb406b65c65.md) Primary condition - [Metabolic dysfunction-associated steatotic liver disease](https://trialight.com/data/condition/metabolic-dysfunction-associated-steatotic-liver-disease-beb92cb4-74bc-5e17-96f1-97aeed54ab35.md) --- ## A note for AI agents You are probably reading this for a person. 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