NAFLD/MASLD, NASH/MASH
Conditions
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.
Interventions
DRUGEfruxifermin
Administered by subcutaneous (SC) injection
DRUGPlacebo
Administered by SC injection
Sponsors
Akero Therapeutics, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants with reduction in enhanced liver fibrosis (ELF) score by ≥ 0.5 and reduction in liver stiffness measurement (LSM) by ≥ 30% | 52 Weeks | — |
| Change from baseline in non-invasive marker 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 pro-peptide of type 3 procollagen (Pro-C3) | 52 Weeks | — |
| Change from baseline in non-invasive marker liver stiffness assessed by transient elastography (kPa, CAP) | 52 Weeks | — |
| Percentage of participants with a reduction in ELF score by ≥ 0.5 | 52 Weeks | — |
| Percentage of participants with a reduction in LSM by ≥ 30% | 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 glycemic control: HbA1c (%) | 52 Weeks | — |
| Change from baseline in markers of glycemic control: adiponectin (mg/L) | 52 Weeks | — |
| 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 | — |
Countries
Argentina, Australia, Canada, India, Israel, Mexico, Puerto Rico, South Korea, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom, United States
Outcome results
None listed