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

Phase 2

Active, not recruiting

• Conditions: NASH - Nonalcoholic Steatohepatitis
• Interventions: Drug: EFX; Drug: Placebo

• Registration Number: NCT04767529
• Lead Sponsor: Akero Therapeutics, Inc

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-16
• Study First Submitted: 2021-02-16
• Study First Submitted QC: 2021-02-22
• Study First Posted: 2021-02-23
• Primary Completion: 2022-07-25
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-20
• Last Update Posted: 2023-04-21
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 128

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 obtained ≤ 180 days prior to 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).

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Exclusion Criteria

• Weight 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EFX 28 mg	EFX	-
EFX 50 mg	EFX	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in liver fibrosis with no worsening steatohepatitis assessed by NASH CRN system	24 Weeks

Secondary Outcome Measures

Name	Time	Method
Resolution of steatohepatitis with no worsening of fibrosis assessed by the NASH CRN system	24 Weeks, 96 Weeks
Change from baseline in liver fibrosis with no worsening of steatohepatitis assessed by the NASH CRN system	96 Weeks
Responder based on NASH CRN: patients who had a decrease of ≥ one point in fibrosis score	24 Weeks, 96 Weeks
Change from baseline in hepatic fat fraction	24 Weeks, 96 Weeks
Change from baseline of non-invasive fibrosis biomarkers - NIS-4	24 Weeks, 48 Weeks, 96 Weeks
Change from baseline of non-invasive fibrosis biomarkers - liver stiffness assessed by transient elastography (FibroScan®)	24 Weeks, 48 Weeks, 96 Weeks
Change from baseline of lipoproteins - Non-HDL-C, HDL-C, and LDL-C	24 Weeks, 48 Weeks, 96 Weeks
Change from baseline of markers of glycemic control - HbA1c	24 Weeks, 48 Weeks, 96 Weeks
Change from baseline of markers of glycemic control - C-Peptide	24 Weeks, 48 Weeks, 96 Weeks
Change from baseline of markers of glycemic control - Adiponectin	24 Weeks, 48 Weeks, 96 Weeks
Change from baseline of non-invasive fibrosis biomarkers - ELF	24 Weeks, 48 Weeks, 96 Weeks
Change from baseline of non-invasive fibrosis biomarkers - Pro-C3	24 Weeks, 48 Weeks, 96 Weeks
Change from baseline of markers of glycemic control - HOMA-IR	24 Weeks, 48 Weeks, 96 Weeks
Change from baseline of body weight	24 Weeks, 48 Weeks, 96 Weeks

Trial Locations

Locations (1)

Akero Clinical Study Site; 🇵🇷 San Juan, Puerto Rico