Clinical trial NCT06161571: A Study Evaluating Efruxifermin in Subjects With Non-invasively Diagnosed Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Nonalcoholic Fatty Liver Disease (NAFLD)/Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Non-invasively Diagnosed Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Nonalcoholic Fatty Liver Disease (NAFLD)/Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: NASH/MASH
NAFLD/MASLD
Lead sponsor: Akero Therapeutics, Inc
Sponsor class: INDUSTRY
First posted: 2023-12-08
Enrollment: 700
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: The aim of this study is to assess the safety and tolerability of EFX compared to placebo in subjects with non-invasively diagnosed NASH/MASH and NAFLD/MASLD.


Eligibility criteria: Inclusion Criteria:

Main Study Only:

* Males and non-pregnant, non-lactating females between 18 - 80 (between 19-80 in the Republic of Korea) years of age inclusive, on the day of signing informed consent
* 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
* Suspected or confirmed diagnosis of NASH/MASH or NAFLD/MASLD or non-invasively diagnosed NASH/MASH or NAFLD/MASLD

Open-Label Rollover

* Prior participation in a previous Akero Phase 2 study

Exclusion Criteria:

* Other causes of liver disease based on medical history and/or liver histology and/or central laboratory results, including but not limited to: alcoholic liver disease, autoimmune disorders (e.g., primary biliary cholangitis \[PBC\], primary sclerosing cholangitis \[PSC\], autoimmune hepatitis), drug induced hepatotoxicity, Wilson disease, clinically significant iron overload, or alpha-1-antitrypsin deficiency
* Type 1 or unstable Type 2 diabetes

A reduced list of inclusion and exclusion criteria apply to participants in the open-label rollover extension.

Other inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Extent of exposure
timeFrame: 52 Weeks
measure: Number of participants with adverse events
timeFrame: 52 Weeks
measure: Number of participants with adverse events by severity
timeFrame: 52 Weeks
measure: Number of participants with clinically significant changes in clinical assessments
timeFrame: 52 Weeks
Secondary outcomes:
measure: Percentage of participants with reduction in enhanced liver fibrosis (ELF) score by ≥ 0.5 and reduction in liver stiffness measurement (LSM) by ≥ 30%
timeFrame: 52 Weeks
measure: Change from baseline in non-invasive marker ELF score
timeFrame: 52 Weeks
measure: Change from baseline in non-invasive marker pro-peptide of type 3 procollagen (Pro-C3)
timeFrame: 52 Weeks
measure: Change from baseline in non-invasive marker liver stiffness assessed by transient elastography (kPa, CAP)
timeFrame: 52 Weeks
measure: Percentage of participants with a reduction in ELF score by ≥ 0.5
timeFrame: 52 Weeks
measure: Percentage of participants with a reduction in LSM by ≥ 30%
timeFrame: 52 Weeks
measure: Change from baseline in lipoproteins
timeFrame: 52 Weeks
measure: Change from baseline in markers of glycemic control: HbA1c (%)
timeFrame: 52 Weeks
measure: Change from baseline in markers of glycemic control: adiponectin (mg/L)
timeFrame: 52 Weeks
measure: Change from baseline in markers of liver injury
timeFrame: 52 Weeks
measure: Change from baseline in markers of liver injury: uric acid (mg/dL)
timeFrame: 52 Weeks
measure: Change from baseline in body weight (kg)
timeFrame: 52 Weeks
Other outcomes:
Locations:
city: Birmingham
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: 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: Chula Vista
country: United States
facility: Akero Clinical Study Site
state: California
city: Coronado
country: United States
facility: Akero Clinical Study Site
state: California
city: Cypress
country: United States
facility: Akero Clinical Study Site
state: California
city: Inglewood
country: United States
facility: Akero Clinical Study Site
state: California
city: La Mesa
country: United States
facility: Akero Clinical Study Site
state: California
city: Lancaster
country: United States
facility: Akero Clinical Study Site
state: California
city: Los Angeles
country: United States
facility: Akero Clinical Study Site
state: California
city: Los Angeles
country: United States
facility: Akero Clinical Study Site
state: California
city: Palm Springs
country: United States
facility: Akero Clinical Study Site
state: California
city: San Diego
country: United States
facility: Akero Clinical Study Site
state: California
city: San Diego
country: United States
facility: Akero Clinical Study Site
state: California
city: San Francisco
country: United States
facility: Akero Clinical Study Site
state: California
city: Santa Maria
country: United States
facility: Akero Clinical Study Site
state: California
city: Englewood
country: United States
facility: Akero Clinical Study Site
state: Colorado
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: Fort Myers
country: United States
facility: Akero Clinical Study Site
state: Florida
city: Gainesville
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: Jacksonville
country: United States
facility: Akero Clinical Study Site
state: Florida
city: Lady Lake
country: United States
facility: Akero Clinical Study Site
state: Florida
city: Lakewood Ranch
country: United States
facility: Akero Clinical Study Site
state: Florida
city: Largo
country: United States
facility: Akero Clinical Study Site
state: Florida
city: Maitland
country: United States
facility: Akero Clinical Study Site
state: Florida
city: Miami Lakes
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: Ocala
country: United States
facility: Akero Clinical Study Site
state: Florida
city: Port Orange
country: United States
facility: Akero Clinical Study Site
state: Florida
city: Sarasota
country: United States
facility: Akero Clinical Study Site
state: Florida
city: The Villages
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: West Palm Beach
country: United States
facility: Akero Clinical Study Site
state: Florida
city: Winter Park
country: United States
facility: Akero Clinical Study Site
state: Florida
city: Winter Park
country: United States
facility: Akero Clinical Study Site
state: Florida
city: Columbus
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: South Bend
country: United States
facility: Akero Clinical Study Site
state: Indiana
city: West Des Moines
country: United States
facility: Akero Clinical Study Site
state: Iowa
city: Topeka
country: United States
facility: Akero Clinical Study Site
state: Kansas
city: Wichita
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: New Orleans
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: Glen Burnie
country: United States
facility: Akero Clinical Study Site
state: Maryland
city: Greenbelt
country: United States
facility: Akero Clinical Study Site
state: Maryland
city: South Dartmouth
country: United States
facility: Akero Clinical Study Site
state: Massachusetts
city: Southfield
country: United States
facility: Akero Clinical Study Site
state: Michigan
city: Wyoming
country: United States
facility: Akero Clinical Study Site
state: Michigan
city: Ypsilanti
country: United States
facility: Akero Clinical Study Site
state: Michigan
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: Las Vegas
country: United States
facility: Akero Clinical Study Site
state: Nevada
city: Reno
country: United States
facility: Akero Clinical Study Site
state: Nevada
city: Brick
country: United States
facility: Akero Clinical Study Site
state: New Jersey
city: Florham Park
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: Santa Fe
country: United States
facility: Akero Clinical Study Site
state: New Mexico
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: 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: 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: New Bern
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: Columbus
country: United States
facility: Akero Clinical Study Site
state: Ohio
city: Dayton
country: United States
facility: Akero Clinical Study Site
state: Ohio
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: Pittsburgh
country: United States
facility: Akero Clinical Study Site
state: Pennsylvania
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: Chattanooga
country: United States
facility: Akero Clinical Study Site
state: Tennessee
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: 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: 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: Houston
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: Lewisville
country: United States
facility: Akero Clinical Study Site
state: Texas
city: McAllen
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: San Antonio
country: United States
facility: Akero Clinical Study Site
state: Texas
city: San Marcos
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: Salt Lake City
country: United States
facility: Akero Clinical Study Site
state: Utah
city: Sandy
country: United States
facility: Akero Clinical Study Site
state: Utah
city: South Ogden
country: United States
facility: Akero Clinical Study Site
state: Utah
city: Falls Church
country: United States
facility: Akero Clinical Study Site
state: Virginia
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: Suffolk
country: United States
facility: Akero Clinical Study Site
state: Virginia
city: Seattle
country: United States
facility: Akero Clinical Study Site
state: Washington
city: Spokane
country: United States
facility: Akero Clinical Study Site
state: Washington
city: Ramos Mejia
country: Argentina
facility: Akero Clinical Study Site
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Akero Clinical Study Site
state: Distrito Federal
city: Buenos Aires
country: Argentina
facility: Akero Clinical Study Site
city: Buenos Aires
country: Argentina
facility: Akero Clinical Study Site
city: Broadmeadow
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: Adelaide
country: Australia
facility: Akero Clinical Study Site
state: South Australia
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: Perth
country: Australia
facility: Akero Clinical Study Site
state: Western Australia
city: Edmonton
country: Canada
facility: Akero Clinical Study Site
state: Alberta
city: Hamilton
country: Canada
facility: Akero Clinical Study Site
state: Ontario
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: New Delhi
country: India
facility: Akero Clinical Study Site
state: Delhi
city: Surat
country: India
facility: Akero Clinical Study Site
state: Gujarat
city: Vadodara
country: India
facility: Akero Clinical Study Site
state: Gujarat
city: Thiruvananthapuram
country: India
facility: Akero Clinical Study Site
state: Kerala
city: Dahegaon
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: Jaipur
country: India
facility: Akero Clinical Study Site
state: Rajasthan
city: Coimbatore
country: India
facility: Akero Clinical Study Site
state: Tamil Nadu
city: Hyderabad
country: India
facility: Akero Clinical Study Site
state: Telangana
city: Varanasi
country: India
facility: Akero Clinical Study Site
state: Uttar Pradesh
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: Petah Tikva
country: Israel
facility: Akero Clinical Study Site
state: Central District
city: Ramat Gan
country: Israel
facility: Akero Clinical Study Site
state: Central District
city: Haifa
country: Israel
facility: Akero Clinical Study Site
state: Haifa District
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: Nazareth
country: Israel
facility: Akero Clinical Study Site
state: Northern District
city: Jerusalem
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: Daegu
country: Korea, Republic of
facility: Akero Clinical Study Site
state: Daegu Gwang'yeogsi
city: Goyang-Si
country: Korea, Republic of
facility: Akero Clinical Study Site
state: Gyeonggi-Do
city: Incheon
country: Korea, Republic of
facility: Akero Clinical Study Site
state: Gyeonggi-do
city: Seongnam-si
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
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: Ciudad de México
country: Mexico
facility: Akero Clinical Study Site
state: Distrito Federal
city: Manatí
country: Puerto Rico
facility: Akero Clinical Study Site
city: San Juan
country: Puerto Rico
facility: Akero Clinical Study Site
city: Olten
country: Switzerland
facility: Akero Clinical Study Site
state: Solothurn
city: Bern
country: Switzerland
facility: Akero Clinical Study Site
city: Sankt Gallen
country: Switzerland
facility: Akero Clinical Study Site
city: Changhua City
country: Taiwan
facility: Akero Clinical Study Site
state: Changhua
city: Taichung City
country: Taiwan
facility: Akero Clinical Study Site
state: Taichung
city: Tainan City
country: Taiwan
facility: Akero Clinical Study Site
state: Tainan
city: Taipei City
country: Taiwan
facility: Akero Clinical Study Site
city: Yenimahalle
country: Turkey
facility: Akero Clinical Study Site
state: Ankara
city: Bornova
country: Turkey
facility: Akero Clinical Study Site
state: Izmir
city: Bursa
country: Turkey
facility: Akero Clinical Study Site
city: Rize
country: Turkey
facility: Akero Clinical Study Site
city: Liverpool
country: United Kingdom
facility: Akero Clinical Study Site
state: England
city: London
country: United Kingdom
facility: Akero Clinical Study Site
state: England
city: London
country: United Kingdom
facility: Akero Clinical Study Site
state: England
city: London
country: United Kingdom
facility: Akero Clinical Study Site
state: England
city: London
country: United Kingdom
facility: Akero Clinical Study Site
state: England
city: London
country: United Kingdom
facility: Akero Clinical Study Site
state: England
city: Newcastle-upon-Tyne
country: United Kingdom
facility: Akero Clinical Study Site
state: England
Study officials:
References: