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NCT06419374PHASE3Recruiting

A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH

89bio, Inc.

Start Date

5/24/2024

Completion Date

8/1/2031

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

Age Range: 18 years to 75 years

Key Inclusion Criteria: * Males or non-pregnant females aged between 18 and 75 years (inclusive) at time of signing the informed consent form (ICF). * Participants must have type 2 diabetes mellitus diagnosed at least 3 months before screening or at least 2 metabolic risk factors. * Biopsy-confirmed fibrosis stage F4 MASH (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 protocol-defined inclusion and exclusion criteria may apply.

Interventions

BIOLOGICAL

Pegozafermin

DRUG

Placebo

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Conditions

Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis

Locations

89bio Clinical Study Site

Birmingham, Alabama 35205

United States

89bio Clinical Study Site

Homewood, Alabama 35209

United States

89bio Clinical Study Site

Chandler, Arizona 85224

United States

89bio Clinical Study Site

Flagstaff, Arizona 86001

United States

89bio Clinical Study Site

Peoria, Arizona 85381

United States

89bio Clinical Study Site

Phoenix, Arizona 85054

United States

89bio Clinical Study Site

Sun City, Arizona 85351

United States

89bio Clinical Study Site

Tucson, Arizona 85712

United States

89bio Clinical Study Site

Tucson, Arizona 85715

United States

89bio Clinical Study Site

Tucson, Arizona 85716

United States

89bio Clinical Study Site

Little Rock, Arkansas 72205

United States

89bio Clinical Study Site

North Little Rock, Arkansas 72117

United States

89bio Clinical Study Site

Camarillo, California 93012

United States

89bio Clinical Study Site

Canoga Park, California 91304

United States

89bio Clinical Study Site

Coronado, California 92118

United States

89bio Clinical Study Site

Fountain Valley, California 92708

United States

89bio Clinical Study Site

Fresno, California 93720

United States

89bio Clinical Study Site

Huntington Park, California 90255

United States

89bio Clinical Study Site

La Jolla, California 92037-0887

United States

89bio Clinical Study Site

Los Angeles, California 90033

United States

89bio Clinical Study Site

Los Angeles, California 90048

United States

89bio Clinical Study Site

Pasadena, California 91105

United States

89bio Clinical Study Site

Poway, California 92064

United States

89bio Clinical Study Site

Redwood City, California 94063

United States

89bio Clinical Study Site

Rialto, California 92377

United States

89bio Clinical Study Site

Sacramento, California 95817

United States

89bio Clinical Study Site

Santa Ana, California 92704

United States

89bio Clinical Study Site

Littleton, Colorado 80120

United States

89bio Clinical Study Site

Clermont, Florida 34711

United States

89bio Clinical Study Site

Fort Myers, Florida 33912

United States

89bio Clinical Study Site

Gainesville, Florida 32610

United States

89bio Clinical Study Site

Hialeah Gardens, Florida 33016

United States

89bio Clinical Study Site

Homestead, Florida 33030

United States

89bio Clinical Study Site

Jacksonville, Florida 32224

United States

89bio Clinical Study Site

Jacksonville, Florida 32256

United States

89bio Clinical Study Site

Lady Lake, Florida 32159

United States

89bio Clinical Study Site

Lakewood Rch, Florida 34211

United States

89bio Clinical Study Site

Lehigh Acres, Florida 33936

United States

89bio Clinical Study Site

Maitland, Florida 32751

United States

89bio Clinical Study Site

Miami, Florida 33144

United States

89bio Clinical Study Site

Miami, Florida 33176-1530

United States

89bio Clinical Study Site

Miami, Florida 33176-7947

United States

89bio Clinical Study Site

New Port Richey, Florida 34653

United States

89bio Clinical Study Site

Ocala, Florida 34471

United States

89bio Clinical Study Site

Ocoee, Florida 34761

United States

89bio Clinical Study Site

Orlando, Florida 32825

United States

89bio Clinical Study Site

University Park, Florida 34201

United States

89bio Clinical Study Site

Viera, Florida 32940

United States

89bio Clinical Study Site

Winter Park, Florida 32789

United States

89bio Clinical Study Site

Athens, Georgia 30607

United States

89bio Clinical Study Site

Atlanta, Georgia 30309

United States

89bio Clinical Study Site

Chicago, Illinois 60611

United States

89bio Clinical Study Site

Hammond, Indiana 46324

United States

89bio Clinical Study Site

New Albany, Indiana 47150

United States

89bio Clinical Study Site

South Bend, Indiana 46635

United States

89bio Clinical Study Site

Iowa City, Iowa 52242

United States

89bio Clinical Study Site

Kansas City, Kansas 66160

United States

89bio Clinical Study Site

Topeka, Kansas 66606

United States

89bio Clinical Study Site

Louisville, Kentucky 40218

United States

89bio Clinical Study Site

Lafayette, Louisiana 70503

United States

89bio Clinical Study Site

Lake Charles, Louisiana 70605

United States

89bio Clinical Study Site

West Monroe, Louisiana 71291

United States

89bio Clinical Study Site

Baltimore, Maryland 21202

United States

89bio Clinical Study Site

Glen Burnie, Maryland 21061

United States

89bio Clinical Study Site

Greenbelt, Maryland 20770

United States

89bio Clinical Study Site

Burlington, Massachusetts 01805

United States

89bio Clinical Study Site

Ann Arbor, Michigan 48109

United States

89bio Clinical Study Site

Clinton Township, Michigan 48038

United States

89bio Clinical Study Site

Detroit, Michigan 48202

United States

89bio Clinical Study Site

Wyoming, Michigan 49519

United States

89bio Clinical Study Site

Ypsilanti, Michigan 48197

United States

89bio Clinical Study Site

Minneapolis, Minnesota 55413

United States

89bio Clinical Study Site

Rochester, Minnesota 55905

United States

89bio Clinical Study Site

Flowood, Mississippi 39232

United States

89bio Clinical Study Site

Tupelo, Mississippi 38801

United States

89bio Clinical Study Site

St Louis, Missouri 63110

United States

89bio Clinical Study Site

St Louis, Missouri 63123

United States

89bio Clinical Study Site

Las Vegas, Nevada 89106

United States

89bio Clinical Study Site

Florham Park, New Jersey 07932

United States

89bio Clinical Study Site

Somers Point, New Jersey 08244

United States

89bio Clinical Study Site

Albuquerque, New Mexico 87109

United States

89bio Clinical Study Site

New York, New York 10016

United States

89bio Clinical Study Site

New York, New York 10021

United States

89bio Clinical Study Site

New York, New York 10033

United States

89bio Clinical Study Site

Asheville, North Carolina 28801

United States

89bio Clinical Study Site

Charlotte, North Carolina 28207

United States

89bio Clinical Study Site

Durham, North Carolina 27710

United States

89bio Clinical Study Site

Fayetteville, North Carolina 28304

United States

89bio Clinical Study Site

Greenville, North Carolina 27834

United States

89bio Clinical Study Site

Winston-Salem, North Carolina 27103

United States

89bio Clinical Study Site

Akron, Ohio 44320

United States

89bio Clinical Study Site

Cincinnati, Ohio 45267

United States

89bio Clinical Study Site

Cleveland, Ohio 44106

United States

89bio Clinical Study Site

Columbus, Ohio 43210

United States

89bio Clinical Study Site

Dayton, Ohio 45145

United States

89bio Clinical Study Site

Dayton, Ohio 45414

United States

89bio Clinical Study Site

Liberty Township, Ohio 45044

United States

89bio Clinical Study Site

Westlake, Ohio 44145

United States

89bio Clinical Study Site

Philadelphia, Pennsylvania 19148

United States

89bio Clinical Study Site

Pittsburgh, Pennsylvania 15213

United States

89bio Clinical Study Site

East Greenwich, Rhode Island 02818

United States

89bio Clinical Study Site

Charleston, South Carolina 29425

United States

89bio Clinical Study Site

Columbia, South Carolina 29204

United States

89bio Clinical Study Site

Rapid City, South Dakota 57701

United States

89bio Clinical Study Site

Cordova, Tennessee 38018

United States

89bio Clinical Study Site

Hermitage, Tennessee 37076

United States

89bio Clinical Study Site

Nashville, Tennessee 37211

United States

89bio Clinical Study Site

Amarillo, Texas 79106

United States

89bio Clinical Study Site

Austin, Texas 78745

United States

89bio Clinical Study Site

Austin, Texas 78757-8059

United States

89bio Clinical Study Site

Austin, Texas 78757-8066

United States

89bio Clinical Study Site

Brownsville, Texas 78520

United States

89bio Clinical Study Site

DeSoto, Texas 75115

United States

89bio Clinical Study Site

Edinburg, Texas 78539

United States

89bio Clinical Study Site

Farmers Branch, Texas 75234

United States

89bio Clinical Study Site

Fort Worth, Texas 76104

United States

89bio Clinical Study Site

Georgetown, Texas 78628

United States

89bio Clinical Study Site

Harlingen, Texas 78550

United States

89bio Clinical Study Site

Houston, Texas 77030

United States

89bio Clinical Study Site

Houston, Texas 77074

United States

89bio Clinical Study Site

Houston, Texas 77090

United States

89bio Clinical Study Site

Houston, Texas 77099

United States

89bio Clinical Study Site

Lewisville, Texas 75067

United States

89bio Clinical Study Site

Lubbock, Texas 79410

United States

89bio Clinical Study Site

Lubbock, Texas 79424

United States

89bio Clinical Study Site

Mansfield, Texas 76063

United States

89bio Clinical Study Site

Pearland, Texas 77584

United States

89bio Clinical Study Site

San Antonio, Texas 78209

United States

89bio Clinical Study Site

San Antonio, Texas 78229-4801

United States

89bio Clinical Study Site

San Antonio, Texas 78229-5069

United States

89bio Clinical Study Site

San Marcos, Texas 78666

United States

89bio Clinical Study Site

Southlake, Texas 76092

United States

89bio Clinical Study Site

Tyler, Texas 75701

United States

89bio Clinical Study Site

Waco, Texas 76710

United States

89bio Clinical Study Site

Waco, Texas 76712

United States

89bio Clinical Study Site

Sandy City, Utah 84092

United States

89bio Clinical Study Site

West Jordan, Utah 84088

United States

89bio Clinical Study Site

Richmond, Virginia 23226

United States

89bio Clinical Study Site

Richmond, Virginia 23229

United States

89bio Clinical Study Site

Richmond, Virginia 23236

United States

89bio Clinical Study Site

Richmond, Virginia 23298

United States

89bio Clinical Study Site

Bellevue, Washington 98004

United States

89bio Clinical Study Site

Seattle, Washington 98101

United States

89bio Clinical Study Site

Seattle, Washington 98105

United States

89bio Clinical Study Site

Tacoma, Washington 98405

United States

89bio Clinical Study Site

Buenos Aires, C1012AAR

Argentina

89bio Clinical Study Site

Buenos Aires, C1125ABE

Argentina

89bio Clinical Study Site

Buenos Aires, C1199ABB

Argentina

89bio Clinical Study Site

Buenos Aires, C1425BGH

Argentina

89bio Clinical Study Site

Buenos Aires, C1425

Argentina

89bio Clinical Study Site

Buenos Aires, CP 1061

Argentina

89bio Clinical Study Site

CABA, C1430CKE

Argentina

89bio Clinical Study Site

Capital Federal, C1280AEB

Argentina

89bio Clinical Study Site

Pilar, B1629AHJ

Argentina

89bio Clinical Study Site

Adelaide, SA 5000

Australia

89bio Clinical Study Site

Fitzroy, 03065

Australia

89bio Clinical Study Site

Greenslopes, 04120

Australia

89bio Clinical Study Site

Heidelberg, 3084

Australia

89bio Clinical Study Site

Herston, Qld 4029

Australia

89bio Clinical Study Site

Murdoch, 06150

Australia

89bio Clinical Study Site

Perth, 06000

Australia

89bio Clinical Study Site

South Brisbane, 04101

Australia

89bio Clinical Study Site

Brussels, 01070

Belgium

89bio Clinical Study Site

Brussels, 01090

Belgium

89bio Clinical Study Site

Brussels, 1200

Belgium

89bio Clinical Study Site

Edegem, 02650

Belgium

89bio Clinical Study Site

Genk, 03600

Belgium

89bio Clinical Study Site

Ghent, 09000

Belgium

89bio Clinical Study Site

Roeselare, 08800

Belgium

89bio Clinical Study Site

Barretos, 14784-400

Brazil

89bio Clinical Study Site

Belo Horizonte, 30220-140

Brazil

89bio Clinical Study Site

Botucatu, 18618-687

Brazil

89bio Clinical Study Site

Brasília, 71625009

Brazil

89bio Clinical Study Site

Goiânia, 74605-050

Brazil

89bio Clinical Study Site

Porto Alegre, 90035-903

Brazil

89bio Clinical Study Site

Rio de Janeiro, 21941-617

Brazil

89bio Clinical Study Site

Salvador, 41820-460

Brazil

89bio Clinical Study Site

São José do Rio Preto, 15090-000

Brazil

89bio Clinical Study Site

São Paulo, 04038-002

Brazil

89bio Clinical Study Site

Vitória, 29055-450

Brazil

89bio Clinical Study Site

Gorna Oryahovitsa, 05100

Bulgaria

89bio Clinical Study Site

Sofia, 01202

Bulgaria

89bio Clinical Study Site

Sofia, 01407

Bulgaria

89bio Clinical Study Site

Stara Zagora, 06003

Bulgaria

89bio Clinical Study Site

Calgary, Alberta T2N 4Z6

Canada

89bio Clinical Study Site

Vancouver, British Columbia V5Z 1M9

Canada

89bio Clinical Study Site

Vancouver, British Columbia V6Z2K5

Canada

89bio Clinical Study Site

Winnipeg, Manitoba R3E 3P4

Canada

89bio Clinical Study Site

London, Ontario N6A5A5

Canada

89bio Clinical Study Site

Ottawa, Ontario K1H 8L6

Canada

89bio Clinical Study Site

Toronto, Ontario M6H3M1

Canada

89bio Clinical Study Site

Vaughan, L4L 4Y7

Canada

89bio Clinical Study Site

Amiens, 80054

France

89bio Clinical Study Site

Dijon, 21000

France

89bio Clinical Study Site

Limoges, 87000

France

89bio Clinical Study Site

Lyon, 69004

France

89bio Clinical Study Site

Montpellier, 34295

France

89bio Clinical Study Site

Nice, 06202

France

89bio Clinical Study Site

Paris, 75012

France

89bio Clinical Study Site

Paris, 75013

France

89bio Clinical Study Site

Paris, 75014

France

89bio Clinical Study Site

Pessac, 33604

France

89bio Clinical Study Site

Strasbourg, 67091

France

89bio Clinical Study Site

Toulouse, 31400

France

89bio Clinical Study Site

Vandœuvre-lès-Nancy, 54500

France

89bio Clinical Study Site

Vénissieux, 69694

France

89bio Clinical Study Site

Villejuif, 94800

France

89bio Clinical Study Site

Chemnitz, 9116

Germany

89bio Clinical Study Site

Frankfurt, 60590

Germany

89bio Clinical Study Site

Freiburg im Breisgau, 79110

Germany

89bio Clinical Study Site

Hanover, 30625

Germany

89bio Clinical Study Site

Homburg, 66421

Germany

89bio Clinical Study Site

Münster, 48149

Germany

89bio Clinical Study Site

Hong Kong,

Hong Kong

89bio Clinical Study Site

Shatin,

Hong Kong

89bio Clinical Study Site

Budapest, 01027

Hungary

89bio Clinical Study Site

Budapest, 01088

Hungary

89bio Clinical Study Site

Budapest, H-1097

Hungary

89bio Clinical Study Site

Gujrāt, 360001

India

89bio Clinical Study Site

Rajpur Sonarpur, 700150

India

89bio Clinical Study Site

Sūrat, 395009

India

89bio Clinical Study Site

Wardha, 442004

India

89bio Clinical Study Site

Afula, 1834111

Israel

89bio Clinical Study Site

Beersheba, 8410101

Israel

89bio Clinical Study Site

Haifa, 3109601

Israel

89bio Clinical Study Site

Haifa, 3436212

Israel

89bio Clinical Study Site

Jerusalem, 9112001

Israel

89bio Clinical Study Site

Nahariya, 2210001

Israel

89bio Clinical Study Site

Petah Tikva, 49100

Israel

89bio Clinical Study Site

Tel Aviv, 69710

Israel

89bio Clinical Study Site

Tel Litwinsky, 5265601

Israel

89bio Clinical Study Site

Bergamo, 24127

Italy

89bio Clinical Study Site

Foggia, 71121

Italy

89bio Clinical Study Site

Milan, 20122

Italy

89bio Clinical Study Site

Milan, 20162

Italy

89bio Clinical Study Site

Novara, 28100

Italy

89bio Clinical Study Site

Palermo, 90127

Italy

89bio Clinical Study Site

Roma, 00128

Italy

89bio Clinical Study Site

Rome, 00168

Italy

89bio Clinical Study Site

Rozzano, 20089

Italy

89bio Clinical Study Site

Torino, 10124

Italy

89bio Clinical Study Site

Chihuahua City, 31217

Mexico

89bio Clinical Study Site

Cuautitlán Izcalli, CP 54769

Mexico

89bio Clinical Study Site

Cuernavaca, 62250

Mexico

89bio Clinical Study Site

Jalisco, 44130

Mexico

89bio Clinical Study Site

Mexico City, 03330

Mexico

89bio Clinical Study Site

Mexico City, 06700

Mexico

89bio Clinical Study Site

Mérida, 97070

Mexico

89bio Clinical Study Site

Monterrey, 64310

Mexico

89bio Clinical Study Site

Amsterdam, 1081 HV

Netherlands

89bio Clinical Study Site

Rotterdam, 3015GD

Netherlands

89bio Clinical Study Site

Tilburg, 5022 GC

Netherlands

89bio Clinical Study Site

Utrecht, 3584 CX

Netherlands

89bio Clinical Study Site

Katowice, 40-752

Poland

89bio Clinical Study Site

Krakow, 31-501

Poland

89bio Clinical Study Site

Lodz, 90-302

Poland

89bio Clinical Study Site

Lodz, 91-363

Poland

89bio Clinical Study Site

Mysłowice, 41-400

Poland

89bio Clinical Study Site

Warsaw, 00-215

Poland

89bio Clinical Study Site

Warsaw, 02-172

Poland

89bio Clinical Study Site

Warsaw, 04-501

Poland

89bio Clinical Study Site

Wroclaw, 53-673

Poland

89bio Clinical Study Site

Manati, 00674

Puerto Rico

89bio Clinical Study Site

Mayagüez, 00680

Puerto Rico

89bio Clinical Study Site

San Juan, 00927

Puerto Rico

89bio Clinical Study Site

Singapore, 119074

Singapore

89bio Clinical Study Site

Singapore, 169608

Singapore

89bio Clinical Study Site

Singapore, 308433

Singapore

89bio Clinical Study Site

Singapore, 529889

Singapore

89bio Clinical Study Site

Bucheon-si, 14584

South Korea

89bio Clinical Study Site

Busan, 49241

South Korea

89bio Clinical Study Site

Daegu, 42415

South Korea

89bio Clinical Study Site

Daegu, 700-712

South Korea

89bio Clinical Study Site

Incheon, 22332

South Korea

89bio Clinical Study Site

Seoul, 03080

South Korea

89bio Clinical Study Site

Seoul, 06591

South Korea

89bio Clinical Study Site

Seoul, 07061

South Korea

89bio Clinical Study Site

Seoul, 07895

South Korea

89bio Clinical Study Site

Seoul, 130-872

South Korea

89bio Clinical Study Site

Almería, 04009

Spain

89bio Clinical Study Site

Badalona, 08916

Spain

89bio Clinical Study Site

Barcelona, 08003

Spain

89bio Clinical Study Site

Barcelona, 08035

Spain

89bio Clinical Study Site

Barcelona, 08041

Spain

89bio Clinical Study Site

Córdoba, 14004

Spain

89bio Clinical Study Site

Madrid, 28007

Spain

89bio Clinical Study Site

Málaga, 29010

Spain

89bio Clinical Study Site

Pontevedra, 36071

Spain

89bio Clinical Study Site

Santander, 39008

Spain

89bio Clinical Study Site

Santiago de Compostela, 15706

Spain

89bio Clinical Study Site

Zaragoza, 50009

Spain

89bio Clinical Study Site

Chiayi City, 60002

Taiwan

89bio Clinical Study Site

Kaohsiung City, 80756

Taiwan

89bio Clinical Study Site

Tainan, 00704

Taiwan

89bio Clinical Study Site

Bornova, İzmir 35040

Turkey (Türkiye)

89bio Clinical Study Site

Merkez, Rize Province 53020

Turkey (Türkiye)

89bio Clinical Study Site

Ankara, 06100

Turkey (Türkiye)

89bio Clinical Study Site

Ankara, 6800

Turkey (Türkiye)

89bio Clinical Study Site

Fatih, 34093

Turkey (Türkiye)

89bio Clinical Study Site

Istanbul, 34010

Turkey (Türkiye)

89bio Clinical Study Site

Istanbul, 34722

Turkey (Türkiye)

89bio Clinical Study Site

Izmir, 35360

Turkey (Türkiye)

89bio Clinical Study Site

Sarıçam, 01790

Turkey (Türkiye)

89bio Clinical Study Site

Umraniye, 34764

Turkey (Türkiye)

89bio Clinical Study Site

Yüreğir, 1370

Turkey (Türkiye)

89bio Clinical Study Site

Aberdeen, AB25 2ZN

United Kingdom

89bio Clinical Study Site

Bristol, BS10 5NB

United Kingdom

89bio Clinical Study Site

Leeds, LS9 7TF

United Kingdom

89bio Clinical Study Site

London, E1 1BB

United Kingdom

89bio Clinical Study Site

London, NW3 2QG

United Kingdom

89bio Clinical Study Site

London, SE5 9RS

United Kingdom

89bio Clinical Study Site

London, W2 1NY

United Kingdom

89bio Clinical Study Site

Oxford, OX3 9DU

United Kingdom

89bio Clinical Study Site

Plymouth, PL6 8DH

United Kingdom

89bio Clinical Study Site

Port Talbot, SA12 7BR

United Kingdom

89bio Clinical Study Site

Portsmouth, P06 3LY

United Kingdom

89bio Clinical Study Site

Southampton, SO16 6YD

United Kingdom