Clinical trial NCT06528314: A Study Evaluating Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Compensated Cirrohosis Due to NASH/MASH
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: NASH - Nonalcoholic Steatohepatitis
MASH - Metabolic Dysfunction-Associated Steatohepatitis
Lead sponsor: Akero Therapeutics, Inc
Sponsor class: INDUSTRY
First posted: 2024-07-30
Enrollment: 1150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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 subjects with compensated cirrhosis due to NASH/MASH.


Eligibility criteria: Inclusion Criteria:

* Cohort 1: Biopsy proven compensated cirrhosis (fibrosis stage 4) due to NASH/MASH
* Cohort 2: Biopsy proven or non-invasively diagnosed compensated cirrhosis (fibrosis stage 4) due to NASH/MASH

Exclusion Criteria:

* Other causes of liver disease based on medical history and/or liver histology and/or central laboratory results
* Type 1 diabetes or unstable Type 2 diabetes
* Any current or prior history of decompensated liver disease

Other inclusion and exclusion criteria may apply

Primary outcomes:
measure: Time from randomization to first occurrence of disease progression as measured by composite of protocol-specified clinical events
timeFrame: 5 years
measure: Cohort 1 only: ≥ 1 stage improvement in fibrosis and no worsening of steatohepatitis
timeFrame: 96 Weeks
Secondary outcomes:
measure: Change from baseline of non-invasive markers of liver fibrosis
timeFrame: 96 Weeks
measure: Change from baseline of non-invasive markers of liver fibrosis
timeFrame: 96 Weeks
measure: Change from baseline of non-invasive markers of liver fibrosis
timeFrame: 96 Weeks
measure: Change from baseline of non-invasive markers of liver fibrosis
timeFrame: 96 Weeks
measure: Change from baseline of markers of liver injury
timeFrame: 96 Weeks
measure: Change from baseline of lipoproteins
timeFrame: 96 Weeks
measure: Change from baseline of markers of insulin sensitivity and glycemic control
timeFrame: 96 Weeks
measure: Change from baseline of markers of insulin sensitivity and glycemic control
timeFrame: 96 Weeks
measure: Change from baseline of markers of insulin sensitivity and glycemic control
timeFrame: 96 Weeks
measure: Change from baseline of markers of insulin sensitivity and glycemic control
timeFrame: 96 Weeks
measure: Change from baseline of markers of insulin sensitivity and glycemic control
timeFrame: 96 Weeks
measure: Change from baseline of body weight (kg)
timeFrame: 96 Weeks
measure: To assess the safety and tolerability of EFX through the reporting of extent of exposure (weeks)
timeFrame: 96 Weeks
measure: To assess the safety and tolerability of EFX through the reporting of adverse events (frequency of events)
timeFrame: 96 Weeks
measure: To assess the safety and tolerability of EFX through the reporting of adverse events (severity of events)
timeFrame: 96 Weeks
measure: Number of participants with abnormal laboratory tests results, abnormal ECGs, abnormal ultrasounds, abnormal vital sign assessments
timeFrame: 96 Weeks
measure: Cohort 1 only: ≥ 1 stage improvement in fibrosis and no worsening of steatohepatitis
timeFrame: 5 Years
measure: Cohort 1 only: ≥ 1 stage improvement in fibrosis
timeFrame: 96 Weeks, 5 Years
measure: Cohort 1 only: Resolution of NASH/MASH
timeFrame: 96 Weeks, 5 Years
measure: Cohort 1 only: Resolution of NASH/MASH and a ≥ 1 stage improvement in fibrosis
timeFrame: 96 Weeks, 5 Years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Akero Clinical Study Site
state: Alabama
city: Dothan
country: United States
facility: Akero Clinical Study Site
state: Alabama
city: Chandler
country: United States
facility: Akero Clinical Study Site
state: Arizona
city: Flagstaff
country: United States
facility: Akero Clinical Study Site
state: Arizona
city: Peoria
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: Tucson
country: United States
facility: Akero Clinical Study Site
state: Arizona
city: Conway
country: United States
facility: Akero Clinical Study Site
state: Arkansas
city: Jonesboro
country: United States
facility: Akero Clinical Study Site
state: Arkansas
city: Little Rock
country: United States
facility: Akero Clinical Study Site
state: Arkansas
city: North Little Rock
country: United States
facility: Akero Clinical Study Site
state: Arkansas
city: Coronado
country: United States
facility: Akero Clinical Study Site
state: California
city: Escondido
country: United States
facility: Akero Clinical Study Site
state: California
city: Folsom
country: United States
facility: Akero Clinical Study Site
state: California
city: Long Beach
country: United States
facility: Akero Clinical Study Site
state: California
city: Newport Beach
country: United States
facility: Akero Clinical Study Site
state: California
city: Orange
country: United States
facility: Akero Clinical Study Site
state: California
city: Pasadena
country: United States
facility: Akero Clinical Study Site
state: California
city: San Francisco
country: United States
facility: Akero Clinical Study Site
state: California
city: Aurora
country: United States
facility: Akero Clinical Study Site
state: Colorado
city: Colorado Springs
country: United States
facility: Akero Clinical Study Site
state: Colorado
city: Englewood
country: United States
facility: Akero Clinical Study Site
state: Colorado
city: New Haven
country: United States
facility: Akero Clinical Study Site
state: Connecticut
city: Bradenton
country: United States
facility: Akero Clinical Study Site
state: Florida
city: Brandon
country: United States
facility: Akero Clinical Study Site
state: Florida
city: Cutler Bay
country: United States
facility: Akero Clinical Study Site
state: Florida
city: Doral
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: Inverness
country: United States
facility: Akero Clinical Study Site
state: Florida
city: Lakewood Ranch
country: United States
facility: Akero Clinical Study Site
state: Florida
city: Lehigh Acres
country: United States
facility: Akero Clinical Study Site
state: Florida
city: Margate
country: United States
facility: Akero Clinical Study Site
state: Florida
city: Miami Gardens
country: United States
facility: Akero Clinical Study Site
state: Florida
city: Miami
country: United States
facility: Akero Clinical Study Site
state: Florida
city: Miami
country: United States
facility: Akero Clinical Study Site
state: Florida
city: Naples
country: United States
facility: Akero Clinical Study Site
state: Florida
city: New Port Richey
country: United States
facility: Akero Clinical Study Site
state: Florida
city: Ocala
country: United States
facility: Akero Clinical Study Site
state: Florida
city: Orlando
country: United States
facility: Akero Clinical Study Site
state: Florida
city: Orlando
country: United States
facility: Akero Clinical Study Site
state: Florida
city: Pembroke Pines
country: United States
facility: Akero Clinical Study Site
state: Florida
city: Sarasota
country: United States
facility: Akero Clinical Study Site
state: Florida
city: Temple Terrace
country: United States
facility: Akero Clinical Study Site
state: Florida
city: Venice
country: United States
facility: Akero Clinical Study Site
state: Florida
city: Viera
country: United States
facility: Akero Clinical Study Site
state: Florida
city: Zephyrhills
country: United States
facility: Akero Clinical Study Site
state: Florida
city: Atlanta
country: United States
facility: Akero Clinical Study Site
state: Georgia
city: Gainesville
country: United States
facility: Akero Clinical Study Site
state: Georgia
city: Marietta
country: United States
facility: Akero Clinical Study Site
state: Georgia
city: Snellville
country: United States
facility: Akero Clinical Study Site
state: Georgia
city: Chicago
country: United States
facility: Akero Clinical Study Site
state: Illinois
city: Hammond
country: United States
facility: Akero Clinical Study Site
state: Indiana
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: Covington
country: United States
facility: Akero Clinical Study Site
state: Louisiana
city: Houma
country: United States
facility: Akero Clinical Study Site
state: Louisiana
city: Marrero
country: United States
facility: Akero Clinical Study Site
state: Louisiana
city: Metairie
country: United States
facility: Akero Clinical Study Site
state: Louisiana
city: Shreveport
country: United States
facility: Akero Clinical Study Site
state: Louisiana
city: Baltimore
country: United States
facility: Akero Clinical Study Site
state: Maryland
city: South Dartmouth
country: United States
facility: Akero Clinical Study Site
state: Massachusetts
city: Clinton Township
country: United States
facility: Akero Clinical Study Site
state: Michigan
city: Novi
country: United States
facility: Akero Clinical Study Site
state: Michigan
city: Southfield
country: United States
facility: Akero Clinical Study Site
state: Michigan
city: Rochester
country: United States
facility: Akero Clinical Study Site
state: Minnesota
city: Flowood
country: United States
facility: Akero Clinical Study Site
state: Mississippi
city: Columbia
country: United States
facility: Akero Clinical Study Site
state: Missouri
city: Kansas City
country: United States
facility: Akero Clinical Study Site
state: Missouri
city: Las Vegas
country: United States
facility: Akero Clinical Study Site
state: Nevada
city: Jackson
country: United States
facility: Akero Clinical Study Site
state: New Jersey
city: Somers Point
country: United States
facility: Akero Clinical Study Site
state: New Jersey
city: Sparta
country: United States
facility: Akero Clinical Study Site
state: New Jersey
city: Buffalo
country: United States
facility: Akero Clinical Study Site
state: New York
city: New York
country: United States
facility: Akero Clinical Study Site
state: New York
city: New York
country: United States
facility: Akero Clinical Study Site
state: New York
city: Rochester
country: United States
facility: Akero Clinical Study Site
state: New York
city: Chapel Hill
country: United States
facility: Akero Clinical Study Site
state: North Carolina
city: Charlotte
country: United States
facility: Akero Clinical Study Site
state: North Carolina
city: Charlotte
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: Raleigh
country: United States
facility: Akero Clinical Study Site
state: North Carolina
city: Statesville
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: Philadelphia
country: United States
facility: Akero Clinical Study Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Akero Clinical Study Site
state: Pennsylvania
city: Charleston
country: United States
facility: Akero Clinical Study Site
state: South Carolina
city: Columbia
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: Clarksville
country: United States
facility: Akero Clinical Study Site
state: Tennessee
city: Hermitage
country: United States
facility: Akero Clinical Study Site
state: Tennessee
city: Nashville
country: United States
facility: Akero Clinical Study Site
state: Tennessee
city: Amarillo
country: United States
facility: Akero Clinical Study Site
state: Texas
city: Austin
country: United States
facility: Akero Clinical Study Site
state: Texas
city: Austin
country: United States
facility: Akero Clinical Study Site
state: Texas
city: Austin
country: United States
facility: Akero Clinical Study Site
state: Texas
city: Bellaire
country: United States
facility: Akero Clinical Study Site
state: Texas
city: Brownsville
country: United States
facility: Akero Clinical Study Site
state: Texas
city: Corpus Christi
country: United States
facility: Akero Clinical Study Site
state: Texas
city: Dallas
country: United States
facility: Akero Clinical Study Site
state: Texas
city: Dallas
country: United States
facility: Akero Clinical Study Site
state: Texas
city: Dallas
country: United States
facility: Akero Clinical Study Site
state: Texas
city: Dallas
country: United States
facility: Akero Clinical Study Site
state: Texas
city: Dallas
country: United States
facility: Akero Clinical Study Site
state: Texas
city: Denison
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 Sam Houston
country: United States
facility: Akero Clinical Study Site
state: Texas
city: Fort Worth
country: United States
facility: Akero Clinical Study Site
state: Texas
city: Garland
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: Pharr
country: United States
facility: Akero Clinical Study Site
state: Texas
city: San Antonio
country: United States
facility: Akero Clinical Study Site
state: Texas
city: San Antonio
country: United States
facility: Akero Clinical Study Site
state: Texas
city: San Antonio
country: United States
facility: Akero Clinical Study Site
state: Texas
city: Sugar Land
country: United States
facility: Akero Clinical Study Site
state: Texas
city: Waco
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: Norfolk
country: United States
facility: Akero Clinical Study Site
state: Virginia
city: Richmond
country: United States
facility: Akero Clinical Study Site
state: Virginia
city: Richmond
country: United States
facility: Akero Clinical Study Site
state: Virginia
city: Richmond
country: United States
facility: Akero Clinical Study Site
state: Virginia
city: Richmond
country: United States
facility: Akero Clinical Study Site
state: Virginia
city: Roanoke
country: United States
facility: Akero Clinical Study Site
state: Virginia
city: Seattle
country: United States
facility: Akero Clinical Study Site
state: Washington
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Akero Clinical Study Site
state: Buenos Aires
city: Ciudad Autónoma De Buenos Aires
country: Argentina
facility: Akero Clinical Study Site
state: Buenos Aires
city: La Plata
country: Argentina
facility: Akero Clinical Study Site
state: Buenos Aires
city: Broadmeadow
country: Australia
facility: Akero Clinical Study Site
state: New South Wales
city: Liverpool
country: Australia
facility: Akero Clinical Study Site
state: New South Wales
city: Westmead
country: Australia
facility: Akero Clinical Study Site
state: New South Wales
city: Herston
country: Australia
facility: Akero Clinical Study Site
state: Queensland
city: Adelaide
country: Australia
facility: Akero Clinical Study Site
state: South Australia
city: Box Hill
country: Australia
facility: Akero Clinical Study Site
state: Victoria
city: Clayton
country: Australia
facility: Akero Clinical Study Site
state: Victoria
city: Epping
country: Australia
facility: Akero Clinical Study Site
state: Victoria
city: Heidelberg
country: Australia
facility: Akero Clinical Study Site
state: Victoria
city: Melbourne
country: Australia
facility: Akero Clinical Study Site
state: Victoria
city: Murdoch
country: Australia
facility: Akero Clinical Study Site
state: Western Australia
city: Nedlands
country: Australia
facility: Akero Clinical Study Site
state: Western Australia
city: Perth
country: Australia
facility: Akero Clinical Study Site
state: Western Australia
city: Edmonton
country: Canada
facility: Akero Clinical Study Site
state: Alberta
city: Toronto
country: Canada
facility: Akero Clinical Study Site
state: Ontario
city: Vaughan
country: Canada
facility: Akero Clinical Study Site
state: Ontario
city: Terrebonne
country: Canada
facility: Akero Clinical Study Site
state: Quebec
city: Santiago
country: Chile
facility: Akero Clinical Study Site
state: Región Metropolitana De Santiago
city: Las Condes
country: Chile
facility: Akero Clinical Study Site
state: Región Metropolitana
city: Strasbourg
country: France
facility: Akero Clinical Study Site
state: Bas-Rhin
city: Clichy
country: France
facility: Akero Clinical Study Site
state: Hauts-de-Seine
city: Paris
country: France
facility: Akero Clinical Study Site
state: Ile-de-France
city: Vandœuvre-lès-Nancy
country: France
facility: Akero Clinical Study Site
state: Lorraine
city: Angers Cedex 9
country: France
facility: Akero Clinical Study Site
state: Maine-et-Loire
city: Toulouse
country: France
facility: Akero Clinical Study Site
state: Occitanie
city: Montpellier Cedex 5
country: France
facility: Akero Clinical Study Site
state: Provence Alpes Cote d'Azur
city: Marseille Cedex 08
country: France
facility: Akero Clinical Study Site
state: Provence-Alpes-Côte d'Azur
city: Nice Cedex 3
country: France
facility: Akero Clinical Study Site
state: Provence-Alpes-Côte d'Azur
city: Lyon
country: France
facility: Akero Clinical Study Site
state: Rhône
city: Le Chesnay
country: France
facility: Akero Clinical Study Site
state: Île-de-France
city: Frankfurt am Main
country: Germany
facility: Akero Clinical Study Site
state: Hessen
city: Leipzig
country: Germany
facility: Akero Clinical Study Site
state: Sachsen
city: Lübeck
country: Germany
facility: Akero Clinical Study Site
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Akero Clinical Study Site
city: Hyderabad
country: India
facility: Akero Clinical Study Site
state: Andhra Pradesh
city: New Delhi
country: India
facility: Akero Clinical Study Site
state: Delhi
city: New Delhi
country: India
facility: Akero Clinical Study Site
state: Delhi
city: New Delhi
country: India
facility: Akero Clinical Study Site
state: Delhi
city: Surat
country: India
facility: Akero Clinical Study Site
state: Gujarat
city: Surat
country: India
facility: Akero Clinical Study Site
state: Gujarat
city: Vadodara
country: India
facility: Akero Clinical Study Site
state: Gujarat
city: Mysore
country: India
facility: Akero Clinical Study Site
state: Karnataka
city: Thiruvananthapuram
country: India
facility: Akero Clinical Study Site
state: Kerala
city: Mumbai
country: India
facility: Akero Clinical Study Site
state: Maharashtra
city: Mumbai
country: India
facility: Akero Clinical Study Site
state: Maharashtra
city: Nagpur
country: India
facility: Akero Clinical Study Site
state: Maharashtra
city: Pune
country: India
facility: Akero Clinical Study Site
state: Maharashtra
city: Chandigarh
country: India
facility: Akero Clinical Study Site
state: Punjab
city: Ludhiana
country: India
facility: Akero Clinical Study Site
state: Punjab
city: Jaipur
country: India
facility: Akero Clinical Study Site
state: Rajasthan
city: Jaipur
country: India
facility: Akero Clinical Study Site
state: Rajasthan
city: Hyderabad
country: India
facility: Akero Clinical Study Site
state: Telangana
city: Varanasi
country: India
facility: Akero Clinical Study Site
state: Uttar Pradesh
city: Varanasi
country: India
facility: Akero Clinical Study Site
state: Uttar Pradesh
city: Rishikesh
country: India
facility: Akero Clinical Study Site
state: Uttaranchal
city: Kolkata
country: India
facility: Akero Clinical Study Site
state: West Bengal
city: Kolkata
country: India
facility: Akero Clinical Study Site
state: West Bengal
city: Kolkata
country: India
facility: Akero Clinical Study Site
state: West Bengal
city: Haifa
country: Israel
facility: Akero Clinical Study Site
state: Haifa District
city: Afula
country: Israel
facility: Akero Clinical Study Site
state: Northern District
city: Nahariya
country: Israel
facility: Akero Clinical Study Site
state: Northern District
city: Haifa
country: Israel
facility: Akero Clinical Study Site
city: Jerusalem
country: Israel
facility: Akero Clinical Study Site
city: Tel Aviv
country: Israel
facility: Akero Clinical Study Site
city: Tel Aviv
country: Israel
facility: Akero Clinical Study Site
city: Milan
country: Italy
facility: Akero Clinical Study Site
city: Novara
country: Italy
facility: Akero Clinical Study Site
city: Daegu
country: Korea, Republic of
facility: Akero Clinical Study Site
state: Daegu Gwang'yeogsi [Taegu-Kwangyokshi]
city: Incheon
country: Korea, Republic of
facility: Akero Clinical Study Site
state: Gyeonggi-do
city: Daegu
country: Korea, Republic of
facility: Akero Clinical Study Site
state: Gyeongsangbugdo [Kyongsangbuk-do]
city: Seoul
country: Korea, Republic of
facility: Akero Clinical Study Site
state: Seoul Teugbyeolsi [Seoul-T'ukpyolshi]
city: Seoul
country: Korea, Republic of
facility: Akero Clinical Study Site
state: Seoul Teugbyeolsi
city: Manatí
country: Puerto Rico
facility: Akero Clinical Study Site
city: Mayagüez
country: Puerto Rico
facility: Akero Clinical Study Site
city: San Juan
country: Puerto Rico
facility: Akero Clinical Study Site
city: Sabadell
country: Spain
facility: Akero Clinical Study Site
state: Barcelona
city: Santander
country: Spain
facility: Akero Clinical Study Site
state: Cantabria
city: Majadahonda
country: Spain
facility: Akero Clinical Study Site
state: Madrid
city: Barcelona
country: Spain
facility: Akero Clinical Study Site
city: Madrid
country: Spain
facility: Akero Clinical Study Site
city: Madrid
country: Spain
facility: Akero Clinical Study Site
city: Valencia
country: Spain
facility: Akero Clinical Study Site
city: Valencia
country: Spain
facility: Akero Clinical Study Site
city: Lugano
country: Switzerland
facility: Akero Clinical Study Site
state: Ticino
city: Bern
country: Switzerland
facility: Akero Clinical Study Site
city: Sankt Gallen
country: Switzerland
facility: Akero Clinical Study Site
city: Zürich
country: Switzerland
facility: Akero Clinical Study Site
city: Bursa
country: Turkey
facility: Akero Clinical Study Site
city: London
country: United Kingdom
facility: Akero Clinical Study Site
state: England
Study officials:
References: