> 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-non-04a60e5b-52b6-4c14-b7bb-c241aa869131 > Record changed: 2026-10-13 # A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis NCT06215716 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06215716) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06215716) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06215716) Participants 1,650 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06215716) Lead sponsor Akero Therapeutics, Inc Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06215716) Start date 2023-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06215716) Number of sites 356 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06215716) ## Title and summary **Summary** This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with non-cirrhotic NASH/MASH and fibrosis stage 2 or 3 (F2 or F3). The study will enroll subjects in two cohorts for a total samples size of 1650 subjects. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06215716) **Short title** A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06215716) **Official title** A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06215716) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06215716) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06215716) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06215716) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06215716) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06215716) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06215716) ## Dates **Completion date** 2033-02-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06215716) **First posted** 2024-01-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06215716) **Registry last updated** 2026-08-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06215716) **Primary completion date** 2033-02-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06215716) **Start date** 2023-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06215716) ## Size and sites **Participants** 1,650 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06215716) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06215716) **Planned participants** 1,650 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06215716) **Protocol amendments** 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06215716) **Randomisation ratio** 1:1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06215716) **Number of sites** 356 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06215716) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06215716) **Lead sponsor** Akero Therapeutics, Inc Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06215716) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06215716) ## Identifiers **Registry ID** NCT06215716 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06215716) **ClinicalTrials.gov ID** NCT06215716 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06215716) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06215716) ## 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/NCT06215716) ## Outcomes ### Primary outcomes 1. Cohort 1 Only: Resolution of NASH/MASH and a ≥ 1 stage improvement in fibrosis Timeframe: 52 Weeks 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/periportal fibrosis, 3 = bridging fibrosis, 4 = cirrhosis) 2. Event-free survival Timeframe: 240 Weeks 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. ### Secondary outcomes 1. Cohort 1 Only: Resolution of NASH/MASH and no worsening of fibrosis Timeframe: 52 Weeks 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/periportal fibrosis, 3 = bridging fibrosis, 4 = cirrhosis) 2. Cohort 1 Only: ≥ 1 stage improvement in fibrosis and no worsening of steatohepatitis Timeframe: 52 Weeks 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/periportal fibrosis, 3 = bridging fibrosis, 4 = cirrhosis) 3. Change from baseline of non-invasive markers of liver fibrosis: ELF score Timeframe: 52 Weeks 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. 4. Change from baseline of non-invasive markers of liver fibrosis: ELF score components (TIMP-1, HA, PIIINP, Pro-C3) Timeframe: 52 Weeks 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) 5. Change from baseline in non-invasive markers of liver fibrosis: ELF score Timeframe: 96 Weeks, 240 Weeks 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. 6. Change from baseline in non-invasive markers of liver fibrosis: ELF score components: TIMP-1, HA, PIIINP, Pro-C3 Timeframe: Week 240 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. 7. Change from baseline of non-invasive markers of liver fibrosis: Fibroscan Timeframe: 52 Weeks Liver stiffness assessed by transient elastography (FibroScan) 8. Change from baseline of non-invasive markers of liver fibrosis: Fibroscan Timeframe: 96 Weeks, 240 Weeks Liver stiffness assessed by transient elastography (FibroScan) 9. Change from baseline of markers of liver injury: ALT, AST, GGT Timeframe: 52 Weeks, 240 Weeks ALT (U/L), AST (U/L), GGT (U/L) 10. Change from baseline of markers of liver injury: Uric Acid Timeframe: 52 Weeks, 240 Weeks Uric acid (mg/dL) 11. Change from baseline of lipoproteins: Total cholesterol, TG, Non-HDL-C, HDL-C, and LDL-C Timeframe: 52 Weeks, 240 Weeks Total cholesterol (mg/dL), TG (mg/dL), Non-HDL-C (mg/dL), HDL-C (mg/dL), and LDL-C (mg/dL) 12. Change from baseline of markers of insulin sensitivity and glycemic control: HbA1c Timeframe: 52 Weeks, 240 Weeks HbA1c (%) 13. Change from baseline of markers of insulin sensitivity and glycemic control: Adiponectin Timeframe: 52 Weeks, 240 Weeks Adiponectin (mg/L) 14. Change from baseline of body weight (kg) Timeframe: 52 Weeks, 240 Weeks 15. To assess the safety and tolerability of EFX through the reporting of extent of exposure (weeks) Timeframe: 52 Weeks, 240 Weeks 16. To assess the safety and tolerability of EFX through the reporting of adverse events (severity of events) Timeframe: 52 Weeks, 240 Weeks 17. To assess the safety and tolerability of EFX through the reporting of adverse events (frequency of events) Timeframe: 52 Weeks, 240 Weeks 18. To assess the safety and tolerability of EFX through the reporting of abnormal clinical laboratory tests, ECGs, ultrasounds, vital sign assessments (number of patients) Timeframe: 52 Weeks, 240 Weeks 19. To assess the immunogenicity of EFX through the reporting of antidrug antibodies (number of patients) Timeframe: 52 Weeks, 240 Weeks Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06215716) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 80 Years **Healthy volunteers** No ### Inclusion criteria - 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/MASH. 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 <4 may be enrolled and are not required to meet 1 point in each of the components of NAS. ### Exclusion criteria - Other causes of liver disease based on medical history and/or liver histology and/or central laboratory results. - Presence of cirrhosis on liver biopsy (fibrosis stage 4). - Type 1 or uncontrolled Type 2 diabetes. Other inclusion and exclusion criteria may apply. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06215716) ## 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 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 SiteChula Vista, United StatesCompleted - Akero Clinical Study SiteCoronado, United StatesRecruiting - Akero Clinical Study SiteEscondido, United StatesRecruiting - Akero Clinical Study SiteFolsom, United StatesRecruiting - Akero Clinical Study SiteInglewood, United StatesRecruiting - Akero Clinical Study SiteLa Mesa, United StatesCompleted - Akero Clinical Study SiteLancaster, United StatesCompleted - Akero Clinical Study SiteLancaster, United StatesRecruiting - Akero Clinical Study SiteLong Beach, United StatesRecruiting - Akero Clinical Study SiteLos Angeles, United StatesCompleted - Akero Clinical Study SiteLos Angeles, United StatesRecruiting - Akero Clinical Study SiteLos Angeles, United StatesRecruiting And 331 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06215716) ## 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) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. Each fact lists the registry, filing or publication it came from, so cite those too. - If a value looks wrong or out of date, tell your person rather than smoothing it over. Registries lag, and so can we. - Trialight puts clinical, regulatory, genetic and commercial data for biotech and pharma in one place, with every value linked to its source. 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