Clinical trial NCT05039450: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: NASH - Nonalcoholic Steatohepatitis
Lead sponsor: Akero Therapeutics, Inc
Sponsor class: INDUSTRY
First posted: 2021-09-09
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Main: Change from baseline in fibrosis with no worsening steatohepatitis assessed by NASH CRN system
timeFrame: Week 36
Secondary outcomes:
measure: Main: Resolution of NASH assessed by the NASH CRN system
timeFrame: Week 36, Week 96
measure: Main: Fibrosis improvement with no worsening of NASH assessed by the NASH CRN system
timeFrame: Week 36, Week 96
measure: Main: Change from baseline in fibrosis in subjects with no worsening of steatohepatitis assessed by the NASH CRN system
timeFrame: Week 96
measure: Main: Change from baseline in fibrosis in subjects with no worsening of steatohepatitis assessed by the NASH CRN system
timeFrame: Week 36, Week 96
measure: Main: Change from baseline in non-invasive markers of fibrosis
timeFrame: Week 36, Week 48, Week 72, Week 96
measure: Main: Change from baseline in lipoproteins
timeFrame: Week 36, Week 48, Week 72, Week 96
measure: Main: Change from baseline of markers in insulin sensitivity and glycemic control
timeFrame: Week 36, Week 48, Week 72, Week 96
measure: Main: Change from baseline in body weight
timeFrame: Week 36, Week 48, Week 96
measure: Main: To assess the immunogenicity of EFX
timeFrame: Through Week 96
measure: Main: To assess the safety and tolerability of EFX
timeFrame: Through Week 96
measure: 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
timeFrame: Through Week 12
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Akero Clinical Study Site
state: Arizona
city: Glendale
country: United States
facility: Akero Clinical Study Site
state: Arizona
city: Tucson
country: United States
facility: Akero Clinical Study Site
state: Arizona
city: Tucson
country: United States
facility: Akero Clinical Study Site
state: Arizona
city: North Little Rock
country: United States
facility: Akero Clinical Study Site
state: Arkansas
city: Fresno
country: United States
facility: Akero Clinical Study Site
state: California
city: Long Beach
country: United States
facility: Akero Clinical Study Site
state: California
city: Los Angeles
country: United States
facility: Akero Clinical Study Site
state: California
city: Pasadena
country: United States
facility: Akero Clinical Study Site
state: California
city: Englewood
country: United States
facility: Akero Clinical Study Site
state: Colorado
city: Clearwater
country: United States
facility: Akero Clinical Study Site
state: Florida
city: Fort Myers
country: United States
facility: Akero Clinical Study Site
state: Florida
city: Fort Myers
country: United States
facility: Akero Clinical Study Site
state: Florida
city: Hialeah Gardens
country: United States
facility: Akero Clinical Study Site
state: Florida
city: Lakewood Ranch
country: United States
facility: Akero Clinical Study Site
state: Florida
city: Miami Lakes
country: United States
facility: Akero Clinical Study Site
state: Florida
city: Ocala
country: United States
facility: Akero Clinical Study Site
state: Florida
city: Sarasota
country: United States
facility: Akero Clinical Study Site
state: Florida
city: South Bend
country: United States
facility: Akero Clinical Study Site
state: Indiana
city: Topeka
country: United States
facility: Akero Clinical Study Site
state: Kansas
city: Bastrop
country: United States
facility: Akero Clinical Study Site
state: Louisiana
city: Marrero
country: United States
facility: Akero Clinical Study Site
state: Louisiana
city: Las Vegas
country: United States
facility: Akero Clinical Study Site
state: Nevada
city: Concord
country: United States
facility: Akero Clinical Study Site
state: North Carolina
city: Fayetteville
country: United States
facility: Akero Clinical Study Site
state: North Carolina
city: Morehead City
country: United States
facility: Akero Clinical Study Site
state: North Carolina
city: Springboro
country: United States
facility: Akero Clinical Study Site
state: Ohio
city: Westlake
country: United States
facility: Akero Clinical Study Site
state: Ohio
city: Greenville
country: United States
facility: Akero Clinical Study Site
state: South Carolina
city: Greenwood
country: United States
facility: Akero Clinical Study Site
state: South Carolina
city: Summerville
country: United States
facility: Akero Clinical Study Site
state: South Carolina
city: Nashville
country: United States
facility: Akero Clinical Study Site
state: Tennessee
city: Austin
country: United States
facility: Akero Clinical Study Site
state: Texas
city: Dallas
country: United States
facility: Akero Clinical Study Site
state: Texas
city: Edinburg
country: United States
facility: Akero Clinical Study Site
state: Texas
city: Edinburg
country: United States
facility: Akero Clinical Study Site
state: Texas
city: Fort Worth
country: United States
facility: Akero Clinical Study Site
state: Texas
city: Fort Worth
country: United States
facility: Akero Clinical Study Site
state: Texas
city: Houston
country: United States
facility: Akero Clinical Study Site
state: Texas
city: Houston
country: United States
facility: Akero Clinical Study Site
state: Texas
city: San Antonio
country: United States
facility: Akero Clinical Study Site
state: Texas
city: Waco
country: United States
facility: Akero Clinical Study Site
state: Texas
city: Webster
country: United States
facility: Akero Clinical Study Site
state: Texas
city: Wichita Falls
country: United States
facility: Akero Clinical Study Site
state: Texas
city: Ogden
country: United States
facility: Akero Clinical Study Site
state: Utah
city: Richmond
country: United States
facility: Akero Clinical Study Site
state: Virginia
city: Mexico City
country: Mexico
facility: Akero Clinical Study Site
city: Monterrey
country: Mexico
facility: Akero Clinical Study Site
city: San Juan
country: Puerto Rico
facility: Akero Clinical Study Site
Study officials:
References: