Clinical trial NCT06318169: A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)
Official title: A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis
Keywords: Liver Diseases
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
Lead sponsor: 89bio, Inc.
Sponsor class: INDUSTRY
First posted: 2024-03-19
Enrollment: 1050
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 study will assess the efficacy and safety of 2 dose regimens of pegozafermin for the treatment of liver fibrosis stage 2 or 3 in adult participants with MASH (previously known as nonalcoholic steatohepatitis \[NASH\]).


Eligibility criteria: Key Inclusion Criteria:

* Males or non-pregnant females aged between 18 and 80 years (inclusive) at time of signing the informed consent form (ICF)
* Biopsy-confirmed MASH (previously named NASH) with fibrosis stage F2 or F3 per NASH clinical research network (CRN) System and NAS ≥4, with a score of at least 1 in each of steatosis, ballooning degeneration, and lobular inflammation or NAS \<4 and/or a ballooning degradation score of 0 with fibrosis stage F3 and a score of at least 1 in steatosis. A historical biopsy must be within 6 months of screening visit (with additional requirements).
* Body mass index (BMI) at screening ≥25.0 kilograms (kg)/meters squared (m\^2) (≥23 kg/m\^2 for Asian countries)

Key Exclusion Criteria:

* Chronic liver diseases other than MASH/NASH
* Evidence of cirrhosis on screening liver biopsy
* Have type 1 diabetes or poorly controlled type 2 diabetes
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥250 units per liter (U/L)
* Participants taking vitamin E (\>400 international units \[IU\]/day) or pioglitazone 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 With at Least an Improvement of Fibrosis ≥1 Stage Without Worsening of MASH/NASH at Week 52
timeFrame: Week 52
measure: Proportion of Participants With MASH/NASH Resolution Without Worsening of Fibrosis at Week 52
timeFrame: Week 52
measure: Time to First Occurrence of Disease Progression
timeFrame: Up to 240 weeks
Secondary outcomes:
measure: Change From Baseline in Liver Fat as Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) at Week 52
timeFrame: Baseline, Week 52
measure: Change from Baseline in Alanine Aminotransferase (ALT) at Week 52 and Month 36
timeFrame: Baseline, Week 52
Other outcomes:
Locations:
city: Birmingham
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: Glendale
country: United States
facility: 89bio Clinical Study Site
state: Arizona
city: Tucson
country: United States
facility: 89bio Clinical Study Site
state: Arizona
city: Conway
country: United States
facility: 89bio Clinical Study Site
state: Arkansas
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: 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: Fresno
country: United States
facility: 89bio Clinical Study Site
state: California
city: Gardena
country: United States
facility: 89bio Clinical Study Site
state: California
city: Huntington Park
country: United States
facility: 89bio Clinical Study Site
state: California
city: Inglewood
country: United States
facility: 89bio Clinical Study Site
state: California
city: Long Beach
country: United States
facility: 89bio Clinical Study Site
state: California
city: Montclair
country: United States
facility: 89bio Clinical Study Site
state: California
city: Orange
country: United States
facility: 89bio Clinical Study Site
state: California
city: Panorama City
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: Rialto
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: Brandon
country: United States
facility: 89bio Clinical Study Site
state: Florida
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: 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: Jupiter
country: United States
facility: 89bio Clinical Study Site
state: Florida
city: Lady Lake
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: Maitland
country: United States
facility: 89bio Clinical Study Site
state: Florida
city: Maitland
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: Sarasota
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: Dalton
country: United States
facility: 89bio Clinical Study Site
state: Georgia
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: Topeka
country: United States
facility: 89bio Clinical Study Site
state: Kansas
city: West Monroe
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: Chesterfield
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: 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: Warren
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: Charlotte
country: United States
facility: 89bio Clinical Study Site
state: North Carolina
city: Durham
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: Winston-Salem
country: United States
facility: 89bio Clinical Study Site
state: North Carolina
city: Dayton
country: United States
facility: 89bio Clinical Study Site
state: Ohio
city: Liberty Township
country: United States
facility: 89bio Clinical Study Site
state: Ohio
city: Springboro
country: United States
facility: 89bio Clinical Study Site
state: Ohio
city: Westlake
country: United States
facility: 89bio Clinical Study Site
state: Ohio
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: Cordova
country: United States
facility: 89bio Clinical Study Site
state: Tennessee
city: Hermitage
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: Bellaire
country: United States
facility: 89bio Clinical Study Site
state: Texas
city: Brownsville
country: United States
facility: 89bio Clinical Study Site
state: Texas
city: Corpus Christi
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 Sam Houston
country: United States
facility: 89bio Clinical Study Site
state: Texas
city: Fort Worth
country: United States
facility: 89bio Clinical Study Site
state: Texas
city: Garland
country: United States
facility: 89bio Clinical Study Site
state: Texas
city: Georgetown
country: United States
facility: 89bio Clinical Study Site
state: Texas
city: Georgetown
country: United States
facility: 89bio Clinical Study Site
state: Texas
city: Houston
country: United States
facility: 89bio Clinical Study Site
state: Texas
city: Katy
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 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: Stafford
country: United States
facility: 89bio Clinical Study Site
state: Texas
city: Tomball
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: Ogden
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: 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: 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: 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: Brisbane
country: Australia
facility: 89bio Clinical Study Site
state: Queensland
city: Herston
country: Australia
facility: 89bio Clinical Study Site
state: Queensland
city: South Brisbane
country: Australia
facility: 89bio Clinical Study Site
state: Queensland
city: Adelaide
country: Australia
facility: 89bio Clinical Study Site
state: South Australia
city: Bedford Park
country: Australia
facility: 89bio Clinical Study Site
state: South Australia
city: Clayton
country: Australia
facility: 89bio Clinical Study Site
state: Victoria
city: Heidelberg
country: Australia
facility: 89bio Clinical Study Site
state: Victoria
city: Perth
country: Australia
facility: 89bio Clinical Study Site
state: West Australia
city: Fitzroy
country: Australia
facility: 89bio Clinical Study Site
city: Brussels
country: Belgium
facility: 89bio Clinical Study Site
city: Brussels
country: Belgium
facility: 89bio Clinical Study Site
city: Edegem
country: Belgium
facility: 89bio Clinical Study Site
city: Ghent
country: Belgium
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: 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: Toronto
country: Canada
facility: 89bio Clinical Study Site
state: Ontario
city: Vaughan
country: Canada
facility: 89bio Clinical Study Site
state: Ontario
city: Amiens
country: France
facility: 89bio Clinical Study Site
city: Bordeaux
country: France
facility: 89bio Clinical Study Site
city: Lille
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: Nantes
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: Pierre-Bénite
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: 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 am Main
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: 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: Petah tikva
country: Israel
facility: 89bio Clinical Study Site
city: Ramat Gan
country: Israel
facility: 89bio Clinical Study Site
city: Tel Aviv
country: Israel
facility: 89bio Clinical Study Site
city: Bergamo
country: Italy
facility: 89bio Clinical Study Site
city: Milano
country: Italy
facility: 89bio Clinical Study Site
city: Milan
country: Italy
facility: 89bio Clinical Study Site
city: Milan
country: Italy
facility: 89bio Clinical Study Site
city: Modena
country: Italy
facility: 89bio Clinical Study Site
city: Palermo
country: Italy
facility: 89bio Clinical Study Site
city: Rome
country: Italy
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: Incheon
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: Rotterdam
country: Netherlands
facility: 89bio Clinical Study Site
state: Zuid Holland
city: Amsterdam
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: 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: 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: 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: 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: 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: Majadahonda
country: Spain
facility: 89bio Clinical Study Site
city: Málaga
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: Sevilla
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: Taipei
country: Taiwan
facility: 89bio Clinical Study Site
city: High Wycombe
country: United Kingdom
facility: 89bio Clinical Study Site
state: Buckinghamshire
city: Bristol
country: United Kingdom
facility: 89bio Clinical Study Site
city: Glasgow
country: United Kingdom
facility: 89bio Clinical Study Site
city: Hull
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: London
country: United Kingdom
facility: 89bio Clinical Study Site
city: London
country: United Kingdom
facility: 89bio Clinical Study Site
city: Oxford
country: United Kingdom
facility: 89bio Clinical Study Site
city: Preston
country: United Kingdom
facility: 89bio Clinical Study Site
city: Southampton
country: United Kingdom
facility: 89bio Clinical Study Site
city: Stockton
country: United Kingdom
facility: 89bio Clinical Study Site
city: Swansea
country: United Kingdom
facility: 89bio Clinical Study Site
city: York
country: United Kingdom
facility: 89bio Clinical Study Site
Study officials:
affiliation: 89bio, Inc.
name: Millie Gottwald, PharmD
role: STUDY_DIRECTOR
References: