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 3Active Not RecruitingNCT06161571

Akero Therapeutics, Inc700 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

700

Conditions

NASH/MASH NAFLD/MASLD

Interventions

EfruxiferminDRUG

Administered by subcutaneous (SC) injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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 * Prior participation in a previous Akero Phase 2 study 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.

Outcomes

Primary Outcomes

Extent of exposure

A participant's extent of exposure to study drug (weeks) will be generated from the data recorded in the study drug administration eCRF.

Time frame: 52 Weeks

Number of participants with adverse events

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.

Time frame: 52 Weeks

Number of participants with adverse events by severity

All AEs, both serious and non-serious, will be assessed for severity using the Common Terminology Criteria for Adverse Events v5.0.

Time frame: 52 Weeks

Number of participants with clinically significant changes in clinical assessments

Clinical assessments include clinical laboratory tests, electrocardiogram, ultrasounds, vital sign assessments, and concomitant medication usage.

Time frame: 52 Weeks

Secondary Outcomes

Percentage of participants with reduction in enhanced liver fibrosis (ELF) score by ≥ 0.5 and reduction in liver stiffness measurement (LSM) by ≥ 30%

Time frame: 52 Weeks

Change from baseline in non-invasive marker ELF score

ELF scale of 6.7 to 9.8 where higher scores indicative of increased fibrosis.

Time frame: 52 Weeks

Change from baseline in non-invasive marker pro-peptide of type 3 procollagen (Pro-C3)

Time frame: 52 Weeks

Change from baseline in non-invasive marker liver stiffness assessed by transient elastography (kPa, CAP)

Time frame: 52 Weeks

Percentage of participants with a reduction in ELF score by ≥ 0.5

Time frame: 52 Weeks

Percentage of participants with a reduction in LSM by ≥ 30%

Time frame: 52 Weeks

Change from baseline in lipoproteins

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).

Time frame: 52 Weeks

Change from baseline in markers of glycemic control: HbA1c (%)

Time frame: 52 Weeks

Change from baseline in markers of glycemic control: adiponectin (mg/L)

Time frame: 52 Weeks

Change from baseline in markers of liver injury

Alanine aminotransferase (ALT) (U/L), aspartate aminotransferase (AST) (U/L), and gamma glutamyl transferase (GGT) (U/L).

Time frame: 52 Weeks

Change from baseline in markers of liver injury: uric acid (mg/dL)

Time frame: 52 Weeks

Change from baseline in body weight (kg)

Time frame: 52 Weeks

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)

Overview

Conditions

Interventions

Eligibility

Locations (211)

Outcomes

Primary Outcomes

Secondary Outcomes