A Study of Efruxifermin in Non-Cirrhotic Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)

Overview

This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in non-cirrhotic subjects with biopsy-proven F2 – F3 NASH.

Full Title of Study: “A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Non-Cirrhotic Subjects With Nonalcoholic Steatohepatitis (NASH)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 2022

Interventions

  • Drug: EFX
    • Administered by subcutaneous injection
  • Drug: Placebo
    • Administered by subcutaneous injection

Arms, Groups and Cohorts

  • Experimental: EFX 28 mg
  • Experimental: EFX 50 mg
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Change from baseline in liver fibrosis with no worsening steatohepatitis assessed by NASH CRN system
    • Time Frame: 24 Weeks

Secondary Measures

  • Resolution of steatohepatitis with no worsening of fibrosis assessed by the NASH CRN system
    • Time Frame: 24 Weeks, 240 Weeks
  • Change from baseline in liver fibrosis with no worsening of steatohepatitis assessed by the NASH CRN system
    • Time Frame: 240 Weeks
  • Responder based on NASH CRN: patients who had a decrease of ≥ one point in fibrosis score
    • Time Frame: 24 Weeks, 240 Weeks
  • Change from baseline in hepatic fat fraction
    • Time Frame: 24 Weeks
  • Change from baseline of lipoproteins – Non-HDL-C, HDL-C, and LDL-C
    • Time Frame: 24 Weeks, 52 Weeks, 240 Weeks
  • Change from baseline of markers of glycemic control – HbA1c
    • Time Frame: 24 Weeks, 52 Weeks, 240 Weeks
  • Change from baseline of markers of glycemic control – C-Peptide
    • Time Frame: 24 Weeks, 52 Weeks, 240 Weeks
  • Change from baseline of markers of glycemic control – Adiponectin
    • Time Frame: 24 Weeks, 52 Weeks, 240 Weeks
  • Change from baseline of markers of glycemic control – HOMA-IR
    • Time Frame: 24 Weeks, 52 Weeks, 240 Weeks
  • Change from baseline of non-invasive fibrosis biomarkers – ELF
    • Time Frame: 24 Weeks, 52 Weeks, 240 Weeks
  • Change from baseline of non-invasive fibrosis biomarkers – Pro-C3
    • Time Frame: 24 Weeks, 52 Weeks, 240 Weeks
  • Change from baseline of non-invasive fibrosis biomarkers – NIS-4
    • Time Frame: 24 Weeks, 52 Weeks, 240 Weeks
  • Change from baseline of non-invasive fibrosis biomarkers – liver stiffness assessed by transient elastography (FibroScan®)
    • Time Frame: 24 Weeks, 52 Weeks, 240 Weeks
  • Change from baseline of body weight
    • Time Frame: 24 Weeks, 52 Weeks, 240 Weeks

Participating in This Clinical Trial

Inclusion Criteria

  • Males and non-pregnant, non-lactating females between 18 – 75 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. – FibroScan® measurement > 8.5 kPa. – Biopsy-proven NASH. Must have had a liver biopsy within 180 days of randomization with fibrosis stage 2 to 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). Exclusion Criteria:

  • Weight gain or loss > 5% in the 3 months prior to screening until randomization or from the time of the diagnostic liver biopsy until randomization, whichever is longer. – Presence of cirrhosis on liver biopsy (stage 4 fibrosis). – Type 1 or uncontrolled Type 2 diabetes. Other inclusion and exclusion criteria may apply.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Akero Therapeutics, Inc
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Akero Study Director, Study Director, Study Director
  • Overall Contact(s)
    • Akero Study Director, 650-487-6488, HarmonyStudies@akerotx.com

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