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

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 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).

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.

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
  • 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 Type

Experimental

Experimental

Placebo Comparator

Arm Label

EFX 28 mg

EFX 50 mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in liver fibrosis with no worsening steatohepatitis assessed by NASH CRN system

Secondary Outcome Measures

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

Full Information

First Posted
February 16, 2021
Last Updated
April 20, 2023
Sponsor
Akero Therapeutics, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT04767529
Brief Title
A Study of Efruxifermin in Non-Cirrhotic Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)
Acronym
Harmony
Official Title
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
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 16, 2021 (Actual)
Primary Completion Date
July 25, 2022 (Actual)
Study Completion Date
May 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 non-cirrhotic subjects with biopsy-proven F2 - F3 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
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EFX 28 mg
Arm Type
Experimental
Arm Title
EFX 50 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
EFX
Intervention Description
Administered by subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered by subcutaneous injection
Primary Outcome Measure Information:
Title
Change from baseline in liver fibrosis with no worsening steatohepatitis assessed by NASH CRN system
Time Frame
24 Weeks
Secondary Outcome Measure Information:
Title
Resolution of steatohepatitis with no worsening of fibrosis assessed by the NASH CRN system
Time Frame
24 Weeks, 96 Weeks
Title
Change from baseline in liver fibrosis with no worsening of steatohepatitis assessed by the NASH CRN system
Time Frame
96 Weeks
Title
Responder based on NASH CRN: patients who had a decrease of ≥ one point in fibrosis score
Time Frame
24 Weeks, 96 Weeks
Title
Change from baseline in hepatic fat fraction
Time Frame
24 Weeks, 96 Weeks
Title
Change from baseline of lipoproteins - Non-HDL-C, HDL-C, and LDL-C
Time Frame
24 Weeks, 48 Weeks, 96 Weeks
Title
Change from baseline of markers of glycemic control - HbA1c
Time Frame
24 Weeks, 48 Weeks, 96 Weeks
Title
Change from baseline of markers of glycemic control - C-Peptide
Time Frame
24 Weeks, 48 Weeks, 96 Weeks
Title
Change from baseline of markers of glycemic control - Adiponectin
Time Frame
24 Weeks, 48 Weeks, 96 Weeks
Title
Change from baseline of markers of glycemic control - HOMA-IR
Time Frame
24 Weeks, 48 Weeks, 96 Weeks
Title
Change from baseline of non-invasive fibrosis biomarkers - ELF
Time Frame
24 Weeks, 48 Weeks, 96 Weeks
Title
Change from baseline of non-invasive fibrosis biomarkers - Pro-C3
Time Frame
24 Weeks, 48 Weeks, 96 Weeks
Title
Change from baseline of non-invasive fibrosis biomarkers - NIS-4
Time Frame
24 Weeks, 48 Weeks, 96 Weeks
Title
Change from baseline of non-invasive fibrosis biomarkers - liver stiffness assessed by transient elastography (FibroScan®)
Time Frame
24 Weeks, 48 Weeks, 96 Weeks
Title
Change from baseline of body weight
Time Frame
24 Weeks, 48 Weeks, 96 Weeks

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 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). 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Akero Study Director
Organizational Affiliation
Study Director
Official's Role
Study Director
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
85304
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
Chula Vista
State/Province
California
ZIP/Postal Code
91910
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
La Jolla
State/Province
California
ZIP/Postal Code
92037
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
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Akero Clinical Study Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Akero Clinical Study Site
City
Orange
State/Province
California
ZIP/Postal Code
92866
Country
United States
Facility Name
Akero Clinical Study Site
City
Panorama City
State/Province
California
ZIP/Postal Code
91402
Country
United States
Facility Name
Akero Clinical Study Site
City
Rialto
State/Province
California
ZIP/Postal Code
92866
Country
United States
Facility Name
Akero Clinical Study Site
City
Santa Ana
State/Province
California
ZIP/Postal Code
92704
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
Inverness
State/Province
Florida
ZIP/Postal Code
34452
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
Miami
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Akero Clinical Study Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33147
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
94240
Country
United States
Facility Name
Akero Clinical Study Site
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
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
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
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
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
Akero Clinical Study Site
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
Akero Clinical Study Site
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Akero Clinical Study Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Akero Clinical Study Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Akero Clinical Study Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27712
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
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
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
Hermitage
State/Province
Tennessee
ZIP/Postal Code
37076
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
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Akero Clinical Study Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78757
Country
United States
Facility Name
Akero Clinical Study Site
City
Cedar Park
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Akero Clinical Study Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
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
78539
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
Garland
State/Province
Texas
ZIP/Postal Code
75044
Country
United States
Facility Name
Akero Clinical Study Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
Facility Name
Akero Clinical Study Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
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
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Akero Clinical Study Site
City
San Marcos
State/Province
Texas
ZIP/Postal Code
78666
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
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Akero Clinical Study Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
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
San Juan
ZIP/Postal Code
927
Country
Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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