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NCT Number: NCT06161571

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)

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

NASH/MASH Digestive System Diseases Fatty Liver Liver Diseases NAFLD/MASLD Non-alcoholic Fatty Liver Disease

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Akero Clinical Study Site, Ramos Mejía, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Efruxifermin

Drug

Administered by subcutaneous (SC) injection

Placebo

Drug

Administered by SC injection

Primary outcomes

  1. Extent of exposure

    Time frame: 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.

  2. Number of participants with adverse events

    Time frame: 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.

  3. Number of participants with adverse events by severity

    Time frame: 52 Weeks

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

  4. Number of participants with clinically significant changes in clinical assessments

    Time frame: 52 Weeks

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

Secondary outcomes

  1. 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

  2. Change from baseline in non-invasive marker ELF score

    Time frame: 52 Weeks

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

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

    Time frame: 52 Weeks

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

    Time frame: 52 Weeks

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

    Time frame: 52 Weeks

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

    Time frame: 52 Weeks

  7. Change from baseline in lipoproteins

    Time frame: 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).

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

    Time frame: 52 Weeks

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

    Time frame: 52 Weeks

  10. Change from baseline in markers of liver injury

    Time frame: 52 Weeks

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

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

    Time frame: 52 Weeks

  12. Change from baseline in body weight (kg)

    Time frame: 52 Weeks

Sponsors and collaborators

Lead sponsor

Akero Therapeutics, Inc

Industry

Registry information

Official study title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of 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)

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 8, 2023
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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