Clinical trial NCT06419374: A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH
Official title: A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Compensated Cirrhosis Due to Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ENLIGHTEN-Cirrhosis)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis
Keywords: Liver disease
Fatty Liver
Digestive System Diseases
Metabolic diseases
Metabolic Dysfunction-Associated Steatohepatitis
MASH
Nonalcoholic steatohepatitis
NASH
Metabolic dysfunction-associated steatotic liver disease
MASLD
Nonalcoholic fatty liver disease
NAFLD
Fibrosis
Cirrhosis
Lead sponsor: 89bio, Inc.
Sponsor class: INDUSTRY
First posted: 2024-05-17
Enrollment: 762
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: The study will assess the efficacy and safety of pegozafermin administered in participants with compensated cirrhosis due to MASH (biopsy-confirmed fibrosis stage F4 MASH \[previously known as nonalcoholic steatohepatitis, NASH\]).


Eligibility criteria: Key Inclusion Criteria:

* Males or non-pregnant females aged between 18 and 75 years (inclusive) at time of signing the informed consent form (ICF).
* At least 1 metabolic risk factor.
* Biopsy-confirmed fibrosis stage F4 MASH (per non-alcoholic steatohepatitis \[NASH\] Clinical Research Network (CRN) system) with compensated cirrhosis.
* Body mass index (BMI) at screening ≥25.0 (≥23.0 for Asian participants) and \<50.0 kilograms (kg)/meters squared (m\^2).

Key Exclusion Criteria:

* Liver disorder other than MASH.
* History or evidence of hepatic decompensation.
* History or evidence of hepatocellular carcinoma.
* Have type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus.
* ALT or aspartate aminotransferase (AST) ≥250 units per liter (U/L).
* Participants taking vitamin E (\>400 international units \[IU\]/day) must be on stable dose for at least 6 months prior to screening.

Other inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Proportion of Participants Achieving Fibrosis Regression
timeFrame: Baseline through Month 24
measure: Time to First Occurrence of Disease Progression as Measured by Composite of Protocol -Specified Clinical Events
timeFrame: Baseline through Month 60
Secondary outcomes:
measure: Change from Baseline in Enhanced Liver Fibrosis (ELF) Score
timeFrame: Baseline, Month 24 and Month 60
measure: Change from Baseline in Alanine Aminotransferase (ALT) Level
timeFrame: Baseline, Month 24 and Month 60
measure: Change from Baseline in FibroScan Vibration-controlled Transient Elastography (VCTE)
timeFrame: Baseline, Month 24 and Month 60
measure: Proportion of Participants who Develop Clinically Significant Portal Hypertension (CSPH)
timeFrame: Baseline through Month 60
Other outcomes:
Locations:
city: Homewood
country: United States
facility: 89bio Clinical Study Site
state: Alabama
city: Chandler
country: United States
facility: 89bio Clinical Study Site
state: Arizona
city: Flagstaff
country: United States
facility: 89bio Clinical Study Site
state: Arizona
city: Peoria
country: United States
facility: 89bio Clinical Study Site
state: Arizona
city: Tucson
country: United States
facility: 89bio Clinical Study Site
state: Arizona
city: Tucson
country: United States
facility: 89bio Clinical Study Site
state: Arizona
city: Tucson
country: United States
facility: 89bio Clinical Study Site
state: Arizona
city: Little Rock
country: United States
facility: 89bio Clinical Study Site
state: Arkansas
city: North Little Rock
country: United States
facility: 89bio Clinical Study Site
state: Arkansas
city: Camarillo
country: United States
facility: 89bio Clinical Study Site
state: California
city: Canoga Park
country: United States
facility: 89bio Clinical Study Site
state: California
city: Coronado
country: United States
facility: 89bio Clinical Study Site
state: California
city: Fountain Valley
country: United States
facility: 89bio Clinical Study Site
state: California
city: Huntington Park
country: United States
facility: 89bio Clinical Study Site
state: California
city: Los Angeles
country: United States
facility: 89bio Clinical Study Site
state: California
city: Pasadena
country: United States
facility: 89bio Clinical Study Site
state: California
city: Poway
country: United States
facility: 89bio Clinical Study Site
state: California
city: Redwood City
country: United States
facility: 89bio Clinical Study Site
state: California
city: Rialto
country: United States
facility: 89bio Clinical Study Site
state: California
city: Sacramento
country: United States
facility: 89bio Clinical Study Site
state: California
city: Santa Ana
country: United States
facility: 89bio Clinical Study Site
state: California
city: Littleton
country: United States
facility: 89bio Clinical Study Site
state: Colorado
city: Clermont
country: United States
facility: 89bio Clinical Study Site
state: Florida
city: Fort Myers
country: United States
facility: 89bio Clinical Study Site
state: Florida
city: Gainesville
country: United States
facility: 89bio Clinical Study Site
state: Florida
city: Hialeah Gardens
country: United States
facility: 89bio Clinical Study Site
state: Florida
city: Jacksonville
country: United States
facility: 89bio Clinical Study Site
state: Florida
city: Lady Lake
country: United States
facility: 89bio Clinical Study Site
state: Florida
city: Lakewood Ranch
country: United States
facility: 89bio Clinical Study Site
state: Florida
city: Lehigh Acres
country: United States
facility: 89bio Clinical Study Site
state: Florida
city: Maitland
country: United States
facility: 89bio Clinical Study Site
state: Florida
city: Miami
country: United States
facility: 89bio Clinical Study Site
state: Florida
city: Miami
country: United States
facility: 89bio Clinical Study Site
state: Florida
city: Miami
country: United States
facility: 89bio Clinical Study Site
state: Florida
city: New Port Richey
country: United States
facility: 89bio Clinical Study Site
state: Florida
city: Ocala
country: United States
facility: 89bio Clinical Study Site
state: Florida
city: Ocoee
country: United States
facility: 89bio Clinical Study Site
state: Florida
city: Orlando
country: United States
facility: 89bio Clinical Study Site
state: Florida
city: University Park
country: United States
facility: 89bio Clinical Study Site
state: Florida
city: Viera
country: United States
facility: 89bio Clinical Study Site
state: Florida
city: Winter Park
country: United States
facility: 89bio Clinical Study Site
state: Florida
city: Athens
country: United States
facility: 89bio Clinical Study Site
state: Georgia
city: Atlanta
country: United States
facility: 89bio Clinical Study Site
state: Georgia
city: Chicago
country: United States
facility: 89bio Clinical Study Site
state: Illinois
city: Hammond
country: United States
facility: 89bio Clinical Study Site
state: Indiana
city: New Albany
country: United States
facility: 89bio Clinical Study Site
state: Indiana
city: Iowa City
country: United States
facility: 89bio Clinical Study Site
state: Iowa
city: Kansas City
country: United States
facility: 89bio Clinical Study Site
state: Kansas
city: Topeka
country: United States
facility: 89bio Clinical Study Site
state: Kansas
city: Lafayette
country: United States
facility: 89bio Clinical Study Site
state: Louisiana
city: Baltimore
country: United States
facility: 89bio Clinical Study Site
state: Maryland
city: Glen Burnie
country: United States
facility: 89bio Clinical Study Site
state: Maryland
city: Greenbelt
country: United States
facility: 89bio Clinical Study Site
state: Maryland
city: Burlington
country: United States
facility: 89bio Clinical Study Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: 89bio Clinical Study Site
state: Michigan
city: Clinton Township
country: United States
facility: 89bio Clinical Study Site
state: Michigan
city: Detroit
country: United States
facility: 89bio Clinical Study Site
state: Michigan
city: Wyoming
country: United States
facility: 89bio Clinical Study Site
state: Michigan
city: Ypsilanti
country: United States
facility: 89bio Clinical Study Site
state: Michigan
city: Minneapolis
country: United States
facility: 89bio Clinical Study Site
state: Minnesota
city: Rochester
country: United States
facility: 89bio Clinical Study Site
state: Minnesota
city: Flowood
country: United States
facility: 89bio Clinical Study Site
state: Mississippi
city: Las Vegas
country: United States
facility: 89bio Clinical Study Site
state: Nevada
city: Florham Park
country: United States
facility: 89bio Clinical Study Site
state: New Jersey
city: Albuquerque
country: United States
facility: 89bio Clinical Study Site
state: New Mexico
city: New York
country: United States
facility: 89bio Clinical Study Site
state: New York
city: New York
country: United States
facility: 89bio Clinical Study Site
state: New York
city: Asheville
country: United States
facility: 89bio Clinical Study Site
state: North Carolina
city: Fayetteville
country: United States
facility: 89bio Clinical Study Site
state: North Carolina
city: Greenville
country: United States
facility: 89bio Clinical Study Site
state: North Carolina
city: Winston-Salem
country: United States
facility: 89bio Clinical Study Site
state: North Carolina
city: Akron
country: United States
facility: 89bio Clinical Study Site
state: Ohio
city: Cincinnati
country: United States
facility: 89bio Clinical Study Site
state: Ohio
city: Cleveland
country: United States
facility: 89bio Clinical Study Site
state: Ohio
city: Columbus
country: United States
facility: 89bio Clinical Study Site
state: Ohio
city: Dayton
country: United States
facility: 89bio Clinical Study Site
state: Ohio
city: Westlake
country: United States
facility: 89bio Clinical Study Site
state: Ohio
city: Philadelphia
country: United States
facility: 89bio Clinical Study Site
state: Pennsylvania
city: East Greenwich
country: United States
facility: 89bio Clinical Study Site
state: Rhode Island
city: Charleston
country: United States
facility: 89bio Clinical Study Site
state: South Carolina
city: Columbia
country: United States
facility: 89bio Clinical Study Site
state: South Carolina
city: Rapid City
country: United States
facility: 89bio Clinical Study Site
state: South Dakota
city: Cordova
country: United States
facility: 89bio Clinical Study Site
state: Tennessee
city: Hermitage
country: United States
facility: 89bio Clinical Study Site
state: Tennessee
city: Nashville
country: United States
facility: 89bio Clinical Study Site
state: Tennessee
city: Austin
country: United States
facility: 89bio Clinical Study Site
state: Texas
city: Austin
country: United States
facility: 89bio Clinical Study Site
state: Texas
city: Austin
country: United States
facility: 89bio Clinical Study Site
state: Texas
city: Brownsville
country: United States
facility: 89bio Clinical Study Site
state: Texas
city: Desoto
country: United States
facility: 89bio Clinical Study Site
state: Texas
city: Edinburg
country: United States
facility: 89bio Clinical Study Site
state: Texas
city: Farmers Branch
country: United States
facility: 89bio Clinical Study Site
state: Texas
city: Fort Worth
country: United States
facility: 89bio Clinical Study Site
state: Texas
city: Harlingen
country: United States
facility: 89bio Clinical Study Site
state: Texas
city: Houston
country: United States
facility: 89bio Clinical Study Site
state: Texas
city: Houston
country: United States
facility: 89bio Clinical Study Site
state: Texas
city: Houston
country: United States
facility: 89bio Clinical Study Site
state: Texas
city: Lubbock
country: United States
facility: 89bio Clinical Study Site
state: Texas
city: Pearland
country: United States
facility: 89bio Clinical Study Site
state: Texas
city: San Antonio
country: United States
facility: 89bio Clinical Study Site
state: Texas
city: San Antonio
country: United States
facility: 89bio Clinical Study Site
state: Texas
city: San Antonio
country: United States
facility: 89bio Clinical Study Site
state: Texas
city: San Marcos
country: United States
facility: 89bio Clinical Study Site
state: Texas
city: Waco
country: United States
facility: 89bio Clinical Study Site
state: Texas
city: Waco
country: United States
facility: 89bio Clinical Study Site
state: Texas
city: Sandy
country: United States
facility: 89bio Clinical Study Site
state: Utah
city: West Jordan
country: United States
facility: 89bio Clinical Study Site
state: Utah
city: Richmond
country: United States
facility: 89bio Clinical Study Site
state: Virginia
city: Richmond
country: United States
facility: 89bio Clinical Study Site
state: Virginia
city: Seattle
country: United States
facility: 89bio Clinical Study Site
state: Washington
city: Seattle
country: United States
facility: 89bio Clinical Study Site
state: Washington
city: Buenos Aires
country: Argentina
facility: 89bio Clinical Study Site
city: Buenos Aires
country: Argentina
facility: 89bio Clinical Study Site
city: Buenos Aires
country: Argentina
facility: 89bio Clinical Study Site
city: Buenos Aires
country: Argentina
facility: 89bio Clinical Study Site
city: Caba
country: Argentina
facility: 89bio Clinical Study Site
city: Capital Federal
country: Argentina
facility: 89bio Clinical Study Site
city: Pilar
country: Argentina
facility: 89bio Clinical Study Site
city: Adelaide
country: Australia
facility: 89bio Clinical Study Site
city: Fitzroy
country: Australia
facility: 89bio Clinical Study Site
city: Greenslopes
country: Australia
facility: 89bio Clinical Study Site
city: Heidelberg
country: Australia
facility: 89bio Clinical Study Site
city: Herston
country: Australia
facility: 89bio Clinical Study Site
city: Murdoch
country: Australia
facility: 89bio Clinical Study Site
city: South Brisbane
country: Australia
facility: 89bio Clinical Study Site
city: Brussel
country: Belgium
facility: 89bio Clinical Study Site
city: Bruxelles
country: Belgium
facility: 89bio Clinical Study Site
city: Edegem
country: Belgium
facility: 89bio Clinical Study Site
city: Genk
country: Belgium
facility: 89bio Clinical Study Site
city: Gent
country: Belgium
facility: 89bio Clinical Study Site
city: Roeselare
country: Belgium
facility: 89bio Clinical Study Site
city: Belo Horizonte
country: Brazil
facility: 89bio Clinical Study Site
city: São José Do Rio Preto
country: Brazil
facility: 89bio Clinical Study Site
city: Gorna Oryahovitsa
country: Bulgaria
facility: 89bio Clinical Study Site
city: Sofia
country: Bulgaria
facility: 89bio Clinical Study Site
city: Sofia
country: Bulgaria
facility: 89bio Clinical Study Site
city: Stara Zagora
country: Bulgaria
facility: 89bio Clinical Study Site
city: Calgary
country: Canada
facility: 89bio Clinical Study Site
state: Alberta
city: Vancouver
country: Canada
facility: 89bio Clinical Study Site
state: British Columbia
city: Vancouver
country: Canada
facility: 89bio Clinical Study Site
state: British Columbia
city: Winnipeg
country: Canada
facility: 89bio Clinical Study Site
state: Manitoba
city: London
country: Canada
facility: 89bio Clinical Study Site
state: Ontario
city: Ottawa
country: Canada
facility: 89bio Clinical Study Site
state: Ontario
city: Toronto
country: Canada
facility: 89bio Clinical Study Site
state: Ontario
city: Vaughan
country: Canada
facility: 89bio Clinical Study Site
city: Amiens
country: France
facility: 89bio Clinical Study Site
city: Dijon
country: France
facility: 89bio Clinical Study Site
city: Limoges
country: France
facility: 89bio Clinical Study Site
city: Lyon
country: France
facility: 89bio Clinical Study Site
city: Montpellier
country: France
facility: 89bio Clinical Study Site
city: Nice
country: France
facility: 89bio Clinical Study Site
city: Paris
country: France
facility: 89bio Clinical Study Site
city: Paris
country: France
facility: 89bio Clinical Study Site
city: Paris
country: France
facility: 89bio Clinical Study Site
city: Pessac CEDEX
country: France
facility: 89bio Clinical Study Site
city: Strasbourg
country: France
facility: 89bio Clinical Study Site
city: Toulouse
country: France
facility: 89bio Clinical Study Site
city: Vandœuvre-lès-Nancy
country: France
facility: 89bio Clinical Study Site
city: Villejuif
country: France
facility: 89bio Clinical Study Site
city: Vénissieux
country: France
facility: 89bio Clinical Study Site
city: Chemnitz
country: Germany
facility: 89bio Clinical Study Site
city: Frankfurt
country: Germany
facility: 89bio Clinical Study Site
city: Freiburg
country: Germany
facility: 89bio Clinical Study Site
city: Hannover
country: Germany
facility: 89bio Clinical Study Site
city: Homburg
country: Germany
facility: 89bio Clinical Study Site
city: Münster
country: Germany
facility: 89bio Clinical Study Site
city: Hong Kong
country: Hong Kong
facility: 89bio Clinical Study Site
city: Shatin
country: Hong Kong
facility: 89bio Clinical Study Site
city: Budapest
country: Hungary
facility: 89bio Clinical Study Site
city: Budapest
country: Hungary
facility: 89bio Clinical Study Site
city: Budapest
country: Hungary
facility: 89bio Clinical Study Site
city: Afula
country: Israel
facility: 89bio Clinical Study Site
city: Be'er Sheva
country: Israel
facility: 89bio Clinical Study Site
city: Haifa
country: Israel
facility: 89bio Clinical Study Site
city: Haifa
country: Israel
facility: 89bio Clinical Study Site
city: Jerusalem
country: Israel
facility: 89bio Clinical Study Site
city: Nahariyya
country: Israel
facility: 89bio Clinical Study Site
city: Petach Tikva
country: Israel
facility: 89bio Clinical Study Site
city: Tel Aviv
country: Israel
facility: 89bio Clinical Study Site
city: Tel HaShomer
country: Israel
facility: 89bio Clinical Study Site
city: Bergamo
country: Italy
facility: 89bio Clinical Study Site
city: Foggia
country: Italy
facility: 89bio Clinical Study Site
city: Milano
country: Italy
facility: 89bio Clinical Study Site
city: Milano
country: Italy
facility: 89bio Clinical Study Site
city: Novara
country: Italy
facility: 89bio Clinical Study Site
city: Palermo
country: Italy
facility: 89bio Clinical Study Site
city: Roma
country: Italy
facility: 89bio Clinical Study Site
city: Rome
country: Italy
facility: 89bio Clinical Study Site
city: Rozzano
country: Italy
facility: 89bio Clinical Study Site
city: Torino
country: Italy
facility: 89bio Clinical Study Site
city: Bucheon
country: Korea, Republic of
facility: 89bio Clinical Study Site
city: Busan
country: Korea, Republic of
facility: 89bio Clinical Study Site
city: Daegu
country: Korea, Republic of
facility: 89bio Clinical Study Site
city: Daegu
country: Korea, Republic of
facility: 89bio Clinical Study Site
city: Seoul
country: Korea, Republic of
facility: 89bio Clinical Study Site
city: Seoul
country: Korea, Republic of
facility: 89bio Clinical Study Site
city: Seoul
country: Korea, Republic of
facility: 89bio Clinical Study Site
city: Seoul
country: Korea, Republic of
facility: 89bio Clinical Study Site
city: Chihuahua
country: Mexico
facility: 89bio Clinical Study Site
city: Ciudad de Mexico
country: Mexico
facility: 89bio Clinical Study Site
city: Ciudad de Mexico
country: Mexico
facility: 89bio Clinical Study Site
city: Cuautitlán Izcalli
country: Mexico
facility: 89bio Clinical Study Site
city: Cuernavaca
country: Mexico
facility: 89bio Clinical Study Site
city: Jalisco
country: Mexico
facility: 89bio Clinical Study Site
city: Merida
country: Mexico
facility: 89bio Clinical Study Site
city: Monterrey
country: Mexico
facility: 89bio Clinical Study Site
city: Amsterdam
country: Netherlands
facility: 89bio Clinical Study Site
city: Rotterdam
country: Netherlands
facility: 89bio Clinical Study Site
city: Tilburg
country: Netherlands
facility: 89bio Clinical Study Site
city: Utrecht
country: Netherlands
facility: 89bio Clinical Study Site
city: Katowice
country: Poland
facility: 89bio Clinical Study Site
city: Kraków
country: Poland
facility: 89bio Clinical Study Site
city: Lodz
country: Poland
facility: 89bio Clinical Study Site
city: Mysłowice
country: Poland
facility: 89bio Clinical Study Site
city: Warsaw
country: Poland
facility: 89bio Clinical Study Site
city: Warszawa
country: Poland
facility: 89bio Clinical Study Site
city: Wrocław
country: Poland
facility: 89bio Clinical Study Site
city: Łódź
country: Poland
facility: 89bio Clinical Study Site
city: Singapore
country: Singapore
facility: 89bio Clinical Study Site
city: Singapore
country: Singapore
facility: 89bio Clinical Study Site
city: Singapore
country: Singapore
facility: 89bio Clinical Study Site
city: Singapore
country: Singapore
facility: 89bio Clinical Study Site
city: Almeria
country: Spain
facility: 89bio Clinical Study Site
city: Badalona
country: Spain
facility: 89bio Clinical Study Site
city: Barcelona
country: Spain
facility: 89bio Clinical Study Site
city: Barcelona
country: Spain
facility: 89bio Clinical Study Site
city: Barcelona
country: Spain
facility: 89bio Clinical Study Site
city: Córdoba
country: Spain
facility: 89bio Clinical Study Site
city: Madrid
country: Spain
facility: 89bio Clinical Study Site
city: Malaga
country: Spain
facility: 89bio Clinical Study Site
city: Pontevedra
country: Spain
facility: 89bio Clinical Study Site
city: Santander
country: Spain
facility: 89bio Clinical Study Site
city: Santiago De Compostela
country: Spain
facility: 89bio Clinical Study Site
city: Zaragoza
country: Spain
facility: 89bio Clinical Study Site
city: Chiayi City
country: Taiwan
facility: 89bio Clinical Study Site
city: Kaohsiung
country: Taiwan
facility: 89bio Clinical Study Site
city: Tainan
country: Taiwan
facility: 89bio Clinical Study Site
city: Bornova
country: Turkey
facility: 89bio Clinical Study Site
state: Izmir
city: Merkez
country: Turkey
facility: 89bio Clinical Study Site
state: Rize
city: Ankara
country: Turkey
facility: 89bio Clinical Study Site
city: Ankara
country: Turkey
facility: 89bio Clinical Study Site
city: Istanbul
country: Turkey
facility: 89bio Clinical Study Site
city: Istanbul
country: Turkey
facility: 89bio Clinical Study Site
city: Aberdeen
country: United Kingdom
facility: 89bio Clinical Study Site
city: Bristol
country: United Kingdom
facility: 89bio Clinical Study Site
city: London
country: United Kingdom
facility: 89bio Clinical Study Site
city: London
country: United Kingdom
facility: 89bio Clinical Study Site
city: Plymouth
country: United Kingdom
facility: 89bio Clinical Study Site
city: Port Talbot
country: United Kingdom
facility: 89bio Clinical Study Site
city: Southampton
country: United Kingdom
facility: 89bio Clinical Study Site
Study officials:
affiliation: 89bio, Inc.
name: Maya Margalit, MD
role: STUDY_DIRECTOR
References: