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NCT05039450 Clinical Trial

A Study of Efruxifermin in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (Symmetry)

NASH - Nonalcoholic Steatohepatitis Clinical Trial

Official title:
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05039450
Other study ID # AK-US-001-0103
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date July 30, 2021
Est. completion date April 2024

Study information
Verified date April 2023
Source Akero Therapeutics, Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in cirrhotic subjects with biopsy-proven F4 compensated NASH.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 200
Est. completion date April 2024
Est. primary completion date October 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Males and non-pregnant, non-lactating females between 18-75 years of age inclusive, based on the date of signing informed consent. - Main Study Only: Previous history or presence of Type 2 diabetes or 2 out of 4 components of metabolic syndrome (obesity, dyslipidemia, elevated blood pressure, elevated fasting glucose). - Main Study Only: Biopsy-proven compensated cirrhosis due to NASH. - Cohort D Only: Diagnosis of type 2 diabetes - Cohort D Only: Use of GLP-1R agonist for at least 90 days - Cohort D Only: Biopsy-proven liver fibrosis stages 1, 2, or 3 Exclusion Criteria: - Main Study Only: Weight loss > 10% in the 90 days prior to screening until randomization or from the time of collection of the liver biopsy used to assess subject eligibility until randomization, whichever is longer. - Type 1 diabetes or uncontrolled Type 2 diabetes - Cohort D Only: Weight loss > 5% in the 90 days prior to screening - Cohort D Only: Presence of cirrhosis on liver biopsy Other inclusion and exclusion criteria may apply

Study Design

Related Conditions & MeSH terms

  • Fatty Liver
  • NASH - Nonalcoholic Steatohepatitis
  • Non-alcoholic Fatty Liver Disease

Intervention

Drug:
• EFX
Investigational drug, Efruxifermin
• Placebo
Placebo

Locations
Country Name City State
Mexico Akero Clinical Study Site Mexico City
Mexico Akero Clinical Study Site Monterrey
Puerto Rico Akero Clinical Study Site San Juan
United States Akero Clinical Study Site Austin Texas
United States Akero Clinical Study Site Bastrop Louisiana
United States Akero Clinical Study Site Chandler Arizona
United States Akero Clinical Study Site Clearwater Florida
United States Akero Clinical Study Site Concord North Carolina
United States Akero Clinical Study Site Dallas Texas
United States Akero Clinical Study Site Edinburg Texas
United States Akero Clinical Study Site Edinburg Texas
United States Akero Clinical Study Site Englewood Colorado
United States Akero Clinical Study Site Fayetteville North Carolina
United States Akero Clinical Study Site Fort Myers Florida
United States Akero Clinical Study Site Fort Myers Florida
United States Akero Clinical Study Site Fort Worth Texas
United States Akero Clinical Study Site Fort Worth Texas
United States Akero Clinical Study Site Fresno California
United States Akero Clinical Study Site Glendale Arizona
United States Akero Clinical Study Site Greenville South Carolina
United States Akero Clinical Study Site Greenwood South Carolina
United States Akero Clinical Study Site Hialeah Gardens Florida
United States Akero Clinical Study Site Houston Texas
United States Akero Clinical Study Site Houston Texas
United States Akero Clinical Study Site Lakewood Ranch Florida
United States Akero Clinical Study Site Las Vegas Nevada
United States Akero Clinical Study Site Long Beach California
United States Akero Clinical Study Site Los Angeles California
United States Akero Clinical Study Site Marrero Louisiana
United States Akero Clinical Study Site Miami Lakes Florida
United States Akero Clinical Study Site Morehead City North Carolina
United States Akero Clinical Study Site Nashville Tennessee
United States Akero Clinical Study Site North Little Rock Arkansas
United States Akero Clinical Study Site Ocala Florida
United States Akero Clinical Study Site Ogden Utah
United States Akero Clinical Study Site Pasadena California
United States Akero Clinical Study Site Richmond Virginia
United States Akero Clinical Study Site San Antonio Texas
United States Akero Clinical Study Site Sarasota Florida
United States Akero Clinical Study Site South Bend Indiana
United States Akero Clinical Study Site Springboro Ohio
United States Akero Clinical Study Site Summerville South Carolina
United States Akero Clinical Study Site Topeka Kansas
United States Akero Clinical Study Site Tucson Arizona
United States Akero Clinical Study Site Tucson Arizona
United States Akero Clinical Study Site Waco Texas
United States Akero Clinical Study Site Webster Texas
United States Akero Clinical Study Site Westlake Ohio
United States Akero Clinical Study Site Wichita Falls Texas

Sponsors (1)
Lead Sponsor Collaborator
Akero Therapeutics, Inc

Countries where clinical trial is conducted

United States,  Mexico,  Puerto Rico, 

Outcome
Type Measure Description Time frame Safety issue
Primary Main: Change from baseline in fibrosis with no worsening steatohepatitis assessed by NASH CRN system Proportion of subjects who achieve = 1 stage improvement in fibrosis (based on NASH CRN fibrosis score) and no worsening of steatohepatitis at Week 36. Week 36
Secondary Main: Resolution of NASH with no worsening of fibrosis assessed by the NASH CRN system Proportion of subjects who achieve NASH resolution (defined as a NAS of 0-1 for inflammation and 0 for ballooning) as determined by the NASH CRN criteria at Week 36 and Week 96 Week 36, Week 96
Secondary Main: Change from baseline in fibrosis in subjects with no worsening of steatohepatitis assessed by the NASH CRN system Proportion of subjects who achieve = 1 stage improvement in fibrosis (based on NASH CRN fibrosis score) and no worsening of steatohepatitis at Week 96 Week 96
Secondary Main: Change from baseline in fibrosis in subjects with no worsening of steatohepatitis assessed by the NASH CRN system Proportion of subjects who achieve = 1 stage improvement in fibrosis (based on NASH CRN fibrosis score) at Week 36 and Week 96 Week 36, Week 96
Secondary Main: Change from baseline in non-invasive markers of fibrosis Change from baseline in ELF score, Pro-C3 (ug/L),and liver stiffness assessed by liver elastography (kPa, CAP) Week 36, Week 48, Week 72, Week 96
Secondary Main: Change from baseline in lipoproteins Change from baseline in Triglycerides (mg/dL), total cholesterol (mg/dL), HDL-C (mg/dL), non-HDL-C (mg/dL), and LDL-C (mg/dL) Week 36, Week 48, Week 72, Week 96
Secondary Main: Change from baseline of markers in insulin sensitivity and glycemic control Change from baseline in HbA1c (%), C-peptide (ug/L), adiponectin (mg/L), insulin (mIU/L), and HOMA-IR Week 36, Week 48, Week 72, Week 96
Secondary Main: Change from baseline in body weight Change from baseline in body weight (kg) Week 36, Week 48, Week 96
Secondary Main: To assess the immunogenicity of EFX Detect and measure ADA, including NAb, against EFX Through Week 96
Secondary Main: To assess the safety and tolerability of EFX Safety and tolerability will be assessed through the reporting of AEs, clinical laboratory tests, ECGs, ultrasounds, vital sign assessments, and concomitant medication usage Through Week 96
Secondary Cohort D: To assess the safety and tolerability of EFX compared to placebo when added to an existing GLP-1R agonist in subjects with type 2 diabetes and liver fibrosis due to NASH Safety and tolerability will be assessed through the reporting of AEs, clinical laboratory assessments, ECGs, ultrasounds, vital sign assessments, and concomitant medication usage Through Week 12
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