A Study Evaluating Efruxifermin in Subjects with Non-invasively Diagnosed Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Nonalcoholic Fatty Liver Disease (NAFLD)/Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

Phase 3

Recruiting

Brief Summary: The aim of this study is to assess the safety and tolerability of EFX compared to placebo in subjects with non-invasively diagnosed NASH/MASH and NAFLD/MASLD.

Recruitment & Eligibility

Inclusion Criteria

Main Study Only:

Males and non-pregnant, non-lactating females between 18 - 80 (between 19-80 in the Republic of Korea) years of age inclusive, on the day of signing informed consent
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
Suspected or confirmed diagnosis of NASH/MASH or NAFLD/MASLD or non-invasively diagnosed NASH/MASH or NAFLD/MASLD

Open-Label Rollover

Exclusion Criteria

Other causes of liver disease based on medical history and/or liver histology and/or central laboratory results, including but not limited to: alcoholic liver disease, autoimmune disorders (e.g., primary biliary cholangitis [PBC], primary sclerosing cholangitis [PSC], autoimmune hepatitis), drug induced hepatotoxicity, Wilson disease, clinically significant iron overload, or alpha-1-antitrypsin deficiency
Type 1 or unstable Type 2 diabetes

A reduced list of inclusion and exclusion criteria apply to participants in the open-label rollover extension.

Other inclusion and exclusion criteria may apply.

Arm && Interventions

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events	52 Weeks	An adverse event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not related to the study drug.
Number of participants with adverse events by severity	52 Weeks	All AEs, both serious and non-serious, will be assessed for severity using the Common Terminology Criteria for Adverse Events v5.0.
Number of participants with clinically significant changes in clinical assessments	52 Weeks	Clinical assessments include clinical laboratory tests, electrocardiogram, ultrasounds, vital sign assessments, and concomitant medication usage.
Extent of exposure	52 Weeks	A participant's extent of exposure to study drug (weeks) will be generated from the data recorded in the study drug administration eCRF.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in markers of glycemic control: HbA1c (%)	52 Weeks
Change from baseline in non-invasive marker enhanced liver fibrosis (ELF) score	52 Weeks	ELF scale of 6.7 to 9.8 where higher scores indicative of increased fibrosis.
Change from baseline in non-invasive marker liver stiffness assessed by transient elastography (kPa, CAP)	52 Weeks
Change from baseline in non-invasive marker fibroscan® aspartate aminotransferase (FAST) score	52 Weeks	FAST score varied on a scale from 0 to 1, with the participants being classified as having low (\<0.35), intermediate (0.35-0.67), or high (\>0.67) probability of having significant inflammatory activity and fibrosis.
Change from baseline in non-invasive marker pro-peptide of type 3 procollagen (Pro-C3)	52 Weeks
Change from baseline in markers of glycemic control: adiponectin (mg/L)	52 Weeks
Change from baseline in lipoproteins	52 Weeks	Total cholesterol (mg/dL), Triglycerides (TG) (mg/dL), high density lipoprotein cholesterol (HDL-C) (mg/dL), Non-HDL-C (mg/dL), and low-density lipoprotein cholesterol (LDL-C) (mg/dL).
Change from baseline in markers of liver injury	52 Weeks	Alanine aminotransferase (ALT) (U/L), aspartate aminotransferase (AST) (U/L), and gamma glutamyl transferase (GGT) (U/L).
Change from baseline in markers of liver injury: uric acid (mg/dL)	52 Weeks
Change from baseline in body weight (kg)	52 Weeks

Locations (1): Akero Clinical Study Site
🇬🇧
Newcastle-upon-Tyne, England, United Kingdom