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

Primary Purpose

NASH - Nonalcoholic Steatohepatitis

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
EFX
Placebo
Sponsored by
Akero Therapeutics, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NASH - Nonalcoholic Steatohepatitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Akero Clinical Study Site
  • Akero Clinical Study Site
  • Akero Clinical Study Site
  • Akero Clinical Study Site
  • Akero Clinical Study Site
  • Akero Clinical Study Site
  • Akero Clinical Study Site
  • Akero Clinical Study Site
  • Akero Clinical Study Site
  • Akero Clinical Study Site
  • Akero Clinical Study Site
  • Akero Clinical Study Site
  • Akero Clinical Study Site
  • Akero Clinical Study Site
  • Akero Clinical Study Site
  • Akero Clinical Study Site
  • Akero Clinical Study Site
  • Akero Clinical Study Site
  • Akero Clinical Study Site
  • Akero Clinical Study Site
  • Akero Clinical Study Site
  • Akero Clinical Study Site
  • Akero Clinical Study Site
  • Akero Clinical Study Site
  • Akero Clinical Study Site
  • Akero Clinical Study Site
  • Akero Clinical Study Site
  • Akero Clinical Study Site
  • Akero Clinical Study Site
  • Akero Clinical Study Site
  • Akero Clinical Study Site
  • Akero Clinical Study Site
  • Akero Clinical Study Site
  • Akero Clinical Study Site
  • Akero Clinical Study Site
  • Akero Clinical Study Site
  • Akero Clinical Study Site
  • Akero Clinical Study Site
  • Akero Clinical Study Site
  • Akero Clinical Study Site
  • Akero Clinical Study Site
  • Akero Clinical Study Site
  • Akero Clinical Study Site
  • Akero Clinical Study Site
  • Akero Clinical Study Site
  • Akero Clinical Study Site
  • Akero Clinical Study Site
  • Akero Clinical Study Site
  • Akero Clinical Study Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

EFX 28 mg (Main Study)

EFX 50 mg (Main Study)

Placebo (Main Study)

EFX 50 mg (Cohort D)

Placebo (Cohort D)

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
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
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)
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)
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
Main: Change from baseline in body weight
Change from baseline in body weight (kg)
Main: To assess the immunogenicity of EFX
Detect and measure ADA, including NAb, against EFX
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
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

Full Information

First Posted
July 29, 2021
Last Updated
April 21, 2023
Sponsor
Akero Therapeutics, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT05039450
Brief Title
A Study of Efruxifermin in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (Symmetry)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 30, 2021 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Akero Therapeutics, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NASH - Nonalcoholic Steatohepatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EFX 28 mg (Main Study)
Arm Type
Experimental
Arm Title
EFX 50 mg (Main Study)
Arm Type
Experimental
Arm Title
Placebo (Main Study)
Arm Type
Placebo Comparator
Arm Title
EFX 50 mg (Cohort D)
Arm Type
Experimental
Arm Title
Placebo (Cohort D)
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
EFX
Intervention Description
Investigational drug, Efruxifermin
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Main: Change from baseline in fibrosis with no worsening steatohepatitis assessed by NASH CRN system
Description
Proportion of subjects who achieve ≥ 1 stage improvement in fibrosis (based on NASH CRN fibrosis score) and no worsening of steatohepatitis at Week 36.
Time Frame
Week 36
Secondary Outcome Measure Information:
Title
Main: Resolution of NASH with no worsening of fibrosis assessed by the NASH CRN system
Description
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
Time Frame
Week 36, Week 96
Title
Main: Change from baseline in fibrosis in subjects with no worsening of steatohepatitis assessed by the NASH CRN system
Description
Proportion of subjects who achieve ≥ 1 stage improvement in fibrosis (based on NASH CRN fibrosis score) and no worsening of steatohepatitis at Week 96
Time Frame
Week 96
Title
Main: Change from baseline in fibrosis in subjects with no worsening of steatohepatitis assessed by the NASH CRN system
Description
Proportion of subjects who achieve ≥ 1 stage improvement in fibrosis (based on NASH CRN fibrosis score) at Week 36 and Week 96
Time Frame
Week 36, Week 96
Title
Main: Change from baseline in non-invasive markers of fibrosis
Description
Change from baseline in ELF score, Pro-C3 (ug/L),and liver stiffness assessed by liver elastography (kPa, CAP)
Time Frame
Week 36, Week 48, Week 72, Week 96
Title
Main: Change from baseline in lipoproteins
Description
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)
Time Frame
Week 36, Week 48, Week 72, Week 96
Title
Main: Change from baseline of markers in insulin sensitivity and glycemic control
Description
Change from baseline in HbA1c (%), C-peptide (ug/L), adiponectin (mg/L), insulin (mIU/L), and HOMA-IR
Time Frame
Week 36, Week 48, Week 72, Week 96
Title
Main: Change from baseline in body weight
Description
Change from baseline in body weight (kg)
Time Frame
Week 36, Week 48, Week 96
Title
Main: To assess the immunogenicity of EFX
Description
Detect and measure ADA, including NAb, against EFX
Time Frame
Through Week 96
Title
Main: To assess the safety and tolerability of EFX
Description
Safety and tolerability will be assessed through the reporting of AEs, clinical laboratory tests, ECGs, ultrasounds, vital sign assessments, and concomitant medication usage
Time Frame
Through Week 96
Title
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
Description
Safety and tolerability will be assessed through the reporting of AEs, clinical laboratory assessments, ECGs, ultrasounds, vital sign assessments, and concomitant medication usage
Time Frame
Through Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Akero Clinical Study Site
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Akero Clinical Study Site
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Akero Clinical Study Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Facility Name
Akero Clinical Study Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Akero Clinical Study Site
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Facility Name
Akero Clinical Study Site
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Akero Clinical Study Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90808
Country
United States
Facility Name
Akero Clinical Study Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Akero Clinical Study Site
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Akero Clinical Study Site
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Akero Clinical Study Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
Akero Clinical Study Site
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33907
Country
United States
Facility Name
Akero Clinical Study Site
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Akero Clinical Study Site
City
Hialeah Gardens
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Akero Clinical Study Site
City
Lakewood Ranch
State/Province
Florida
ZIP/Postal Code
34211
Country
United States
Facility Name
Akero Clinical Study Site
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Akero Clinical Study Site
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Akero Clinical Study Site
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34240
Country
United States
Facility Name
Akero Clinical Study Site
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46635
Country
United States
Facility Name
Akero Clinical Study Site
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Akero Clinical Study Site
City
Bastrop
State/Province
Louisiana
ZIP/Postal Code
71220
Country
United States
Facility Name
Akero Clinical Study Site
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
Akero Clinical Study Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Akero Clinical Study Site
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28027
Country
United States
Facility Name
Akero Clinical Study Site
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
Facility Name
Akero Clinical Study Site
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
Akero Clinical Study Site
City
Springboro
State/Province
Ohio
ZIP/Postal Code
45066
Country
United States
Facility Name
Akero Clinical Study Site
City
Westlake
State/Province
Ohio
ZIP/Postal Code
44145
Country
United States
Facility Name
Akero Clinical Study Site
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Akero Clinical Study Site
City
Greenwood
State/Province
South Carolina
ZIP/Postal Code
29646
Country
United States
Facility Name
Akero Clinical Study Site
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29485
Country
United States
Facility Name
Akero Clinical Study Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37211
Country
United States
Facility Name
Akero Clinical Study Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78746
Country
United States
Facility Name
Akero Clinical Study Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Akero Clinical Study Site
City
Edinburg
State/Province
Texas
ZIP/Postal Code
78504
Country
United States
Facility Name
Akero Clinical Study Site
City
Edinburg
State/Province
Texas
ZIP/Postal Code
78539
Country
United States
Facility Name
Akero Clinical Study Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
75044
Country
United States
Facility Name
Akero Clinical Study Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Akero Clinical Study Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Akero Clinical Study Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77079
Country
United States
Facility Name
Akero Clinical Study Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Akero Clinical Study Site
City
Waco
State/Province
Texas
ZIP/Postal Code
76710
Country
United States
Facility Name
Akero Clinical Study Site
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Akero Clinical Study Site
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76301
Country
United States
Facility Name
Akero Clinical Study Site
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
Akero Clinical Study Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Akero Clinical Study Site
City
Mexico City
Country
Mexico
Facility Name
Akero Clinical Study Site
City
Monterrey
Country
Mexico
Facility Name
Akero Clinical Study Site
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD
No

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

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