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Purpose

The study will assess the efficacy and safety of 2 dose regimens of pegozafermin compared to placebo for the treatment of liver fibrosis stage F2 or F3 in adult participants with MASH.

Condition

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 with fibrosis stage F2 or F3 - Body mass index (BMI) at screening ≥25.0 kilograms (kg)/meters squared (m^2) (≥23 kg/m^2 for Asian participants).

Exclusion Criteria

  • Chronic liver diseases other than MASH - 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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Pegozafermin Regimen 1
  • Biological: Pegozafermin
    Subcutaneous injection
    Other names:
    • BIO89-100
Experimental
Pegozafermin Regimen 2
  • Biological: Pegozafermin
    Subcutaneous injection
    Other names:
    • BIO89-100
Placebo Comparator
Placebo 		Matched Placebo will be administered in Regimens 1 and 2.
  • Other: Placebo
    Subcutaneous injection

Recruiting Locations

89bio Clinical Study Site
Birmingham, Alabama 35209
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89bio Clinical Study Site
Chandler, Arizona 85224
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89bio Clinical Study Site
Flagstaff, Arizona 86001
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89bio Clinical Study Site
Glendale, Arizona 85036
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89bio Clinical Study Site
Tucson, Arizona 85712
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89bio Clinical Study Site
Little Rock, Arkansas 72211-3859
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89bio Clinical Study Site
North Little Rock, Arkansas 72117
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89bio Clinical Study Site
Canoga Park, California 91604
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89bio Clinical Study Site
Coronado, California 92118
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89bio Clinical Study Site
Fountain Valley, California 92708
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89bio Clinical Study Site
Fresno, California 93720
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89bio Clinical Study Site
Gardena, California 90247
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89bio Clinical Study Site
Inglewood, California 90301
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89bio Clinical Study Site
La Jolla, California 92037
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89bio Clinical Study Site
Lancaster, California 93534
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89bio Clinical Study Site
Long Beach, California 90815
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89bio Clinical Study Site
Los Angeles, California 90048
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89bio Clinical Study Site
Montclair, California 91763
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89bio Clinical Study Site
Orange, California 92868
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89bio Clinical Study Site
Panorama City, California 91402
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89bio Clinical Study Site
Pasadena, California 91105
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89bio Clinical Study Site
Poway, California 92064
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89bio Clinical Study Site
Rialto, California 92377
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89bio Clinical Study Site
Stanford, California 94305
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89bio Clinical Study Site
Victorville, California 92395
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89bio Clinical Study Site
Colorado Springs, Colorado 80923
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89bio Clinical Study Site
Littleton, Colorado 80120
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89bio Clinical Study Site
Brandon, Florida 33511
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89bio Clinical Study Site
Clermont, Florida 34711
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89bio Clinical Study Site
Fort Myers, Florida 33912
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89bio Clinical Study Site
Hialeah Gardens, Florida 33016
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89bio Clinical Study Site
Homestead, Florida 33030
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89bio Clinical Study Site
Jacksonville, Florida 32256
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89bio Clinical Study Site
Jupiter, Florida 33458
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89bio Clinical Study Site
Lady Lake, Florida 32159-6831
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89bio Clinical Study Site
Lakewood Rch, Florida 34211
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89bio Clinical Study Site
Lehigh Acres, Florida 33936
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89bio Clinical Study Site
Maitland, Florida 32751-7258
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89bio Clinical Study Site
Maitland, Florida 32751-7497
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89bio Clinical Study Site
New Port Richey, Florida 34653
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89bio Clinical Study Site
Ocala, Florida 34471
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89bio Clinical Study Site
Ocoee, Florida 34761
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89bio Clinical Study Site
Sarasota, Florida 34240
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89bio Clinical Study Site
Winter Park, Florida 32789
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89bio Clinical Study Site
Athens, Georgia 30607
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89bio Clinical Study Site
Dalton, Georgia 30720
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89bio Clinical Study Site
Chicago, Illinois 60611
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89bio Clinical Study Site
Hammond, Indiana 46324
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89bio Clinical Study Site
New Albany, Indiana 47150
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89bio Clinical Study Site
South Bend, Indiana 46635
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89bio Clinical Study Site
Iowa City, Iowa 52242
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89bio Clinical Study Site
Topeka, Kansas 66606
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89bio Clinical Study Site
Covington, Louisiana 70433
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89bio Clinical Study Site
Houma, Louisiana 70360
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89bio Clinical Study Site
Lake Charles, Louisiana 70605
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89bio Clinical Study Site
Marrero, Louisiana 70072
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89bio Clinical Study Site
New Orleans, Louisiana 70115
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89bio Clinical Study Site
West Monroe, Louisiana 71291
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89bio Clinical Study Site
Baltimore, Maryland 21202
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89bio Clinical Study Site
Glen Burnie, Maryland 21061
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89bio Clinical Study Site
Greenbelt, Maryland 20770
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89bio Clinical Study Site
Burlington, Massachusetts 01805
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89bio Clinical Study Site
Chesterfield, Michigan 48047
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89bio Clinical Study Site
Wyoming, Michigan 49519
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89bio Clinical Study Site
Ypsilanti, Michigan 48197
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89bio Clinical Study Site
Rochester, Minnesota 55905
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89bio Clinical Study Site
Flowood, Mississippi 39232
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89bio Clinical Study Site
St Louis, Missouri 63123
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89bio Clinical Study Site
Las Vegas, Nevada 89106
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89bio Clinical Study Site
Freehold, New Jersey 07728
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89bio Clinical Study Site
Warren Township, New Jersey 07059
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89bio Clinical Study Site
Albuquerque, New Mexico 87109
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89bio Clinical Study Site
Carmel, New York 10512
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89bio Clinical Study Site
New York, New York 10021
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89bio Clinical Study Site
Charlotte, North Carolina 28207
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89bio Clinical Study Site
Durham, North Carolina 27710
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89bio Clinical Study Site
Fayetteville, North Carolina 28304
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89bio Clinical Study Site
Morehead City, North Carolina 28557
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89bio Clinical Study Site
Raleigh, North Carolina 27612
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89bio Clinical Study Site
Winston-Salem, North Carolina 27103
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89bio Clinical Study Site
Akron, Ohio 44320
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89bio Clinical Study Site
Cleveland, Ohio 44106
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89bio Clinical Study Site
Dayton, Ohio 45414
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89bio Clinical Study Site
Liberty Township, Ohio 45044
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89bio Clinical Study Site
Lima, Ohio 45801
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89bio Clinical Study Site
Springboro, Ohio 45066
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89bio Clinical Study Site
Westlake, Ohio 44145
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89bio Clinical Study Site
East Greenwich, Rhode Island 02818
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89bio Clinical Study Site
Charleston, South Carolina 29425
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89bio Clinical Study Site
Columbia, South Carolina 29204
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89bio Clinical Study Site
Chattanooga, Tennessee 37421
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89bio Clinical Study Site
Cordova, Tennessee 38018
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89bio Clinical Study Site
Hermitage, Tennessee 37076
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89bio Clinical Study Site
Nashville, Tennessee 37211
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89bio Clinical Study Site
Amarillo, Texas 79106
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89bio Clinical Study Site
Austin, Texas 78745
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89bio Clinical Study Site
Austin, Texas 78757-8051
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89bio Clinical Study Site
Austin, Texas 78757
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89bio Clinical Study Site
Bellaire, Texas 77401
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89bio Clinical Study Site
Brownsville, Texas 78520
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89bio Clinical Study Site
Corpus Christi, Texas 78404
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89bio Clinical Study Site
DeSoto, Texas 75115
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89bio Clinical Study Site
Edinburg, Texas 78539
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89bio Clinical Study Site
Farmers Branch, Texas 75234
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89bio Clinical Study Site
Fort Worth, Texas 76104
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89bio Clinical Study Site
Garland, Texas 75044
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89bio Clinical Study Site
Georgetown, Texas 78626
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89bio Clinical Study Site
Georgetown, Texas 78628
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89bio Clinical Study Site
Houston, Texas 77030
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89bio Clinical Study Site
Houston, Texas 77099
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89bio Clinical Study Site
Katy, Texas 77494
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89bio Clinical Study Site
San Antonio, Texas 78209
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89bio Clinical Study Site
San Antonio, Texas 78215
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89bio Clinical Study Site
San Antonio, Texas 78222
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89bio Clinical Study Site
San Antonio, Texas 78229-4801
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89bio Clinical Study Site
San Antonio, Texas 78229
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89bio Clinical Study Site
Stafford, Texas 77477
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89bio Clinical Study Site
Tomball, Texas 77584
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89bio Clinical Study Site
Waco, Texas 76301
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89bio Clinical Study Site
Waco, Texas 76710
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89bio Clinical Study Site
Ogden, Utah 84405
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89bio Clinical Study Site
Richmond, Virginia 23226-1925
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89bio Clinical Study Site
Richmond, Virginia 23236
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89bio Clinical Study Site
Richmond, Virginia 23298
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89bio Clinical Study Site
Roanoke, Virginia 24014
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89bio Clinical Study Site
Seattle, Washington 98101
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89bio Clinical Study Site
Seattle, Washington 98105
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89bio Clinical Study Site
Manati, Puerto Rico 00674
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89bio Clinical Study Site
Mayagüez, Puerto Rico 00680
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89bio Clinical Study Site
San Juan, Puerto Rico 00927
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More Details

NCT ID
NCT06318169
Status
Recruiting
Sponsor
89bio, Inc.

Study Contact

ENLIGHTEN clinical trial
1-415-432-9270
enlighten@89bio.com

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