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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

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Birmingham, Alabama 35209
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Chandler, Arizona 85224
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Glendale, Arizona 85036
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Sun City, Arizona 85351
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Tucson, Arizona 85712
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Little Rock, Arkansas 72211-3859
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North Little Rock, Arkansas 72117
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Canoga Park, California 91604
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Coronado, California 92118
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Escondido, California 92025
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Fountain Valley, California 92708
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Fresno, California 93720
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Gardena, California 90247
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Inglewood, California 90301
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La Jolla, California 92037
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Lancaster, California 93534
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Long Beach, California 90815
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Los Angeles, California 90048
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Montclair, California 91763
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Orange, California 92868
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Pasadena, California 91105
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Poway, California 92064
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Rialto, California 92377
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Stanford, California 94305
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Victorville, California 92395
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Littleton, Colorado 80120
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Brandon, Florida 33511
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Clermont, Florida 34711
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Fort Myers, Florida 33912
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Hialeah Gardens, Florida 33016
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Homestead, Florida 33030
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Jacksonville, Florida 32256
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Jupiter, Florida 33458
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Lady Lake, Florida 32159-6831
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Lakewood Rch, Florida 34211
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Lehigh Acres, Florida 33936
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Maitland, Florida 32751-7258
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Maitland, Florida 32751-7497
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New Port Richey, Florida 34653
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Ocala, Florida 34471
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Ocoee, Florida 34761
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Sarasota, Florida 34240
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Winter Park, Florida 32789
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Athens, Georgia 30607
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Dalton, Georgia 30720
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Marietta, Georgia 30060
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Chicago, Illinois 60611
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Hammond, Indiana 46324
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New Albany, Indiana 47150
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South Bend, Indiana 46635
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Iowa City, Iowa 52242
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Topeka, Kansas 66606
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Louisville, Kentucky 40218
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Covington, Louisiana 70433
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Houma, Louisiana 70360
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Lake Charles, Louisiana 70605
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Marrero, Louisiana 70072
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New Orleans, Louisiana 70115
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West Monroe, Louisiana 71291
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Baltimore, Maryland 21202
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Glen Burnie, Maryland 21061
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Greenbelt, Maryland 20770
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Burlington, Massachusetts 01805
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Chesterfield, Michigan 48047
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Wyoming, Michigan 49519
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Ypsilanti, Michigan 48197
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Maplewood, Minnesota 55109
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Rochester, Minnesota 55905
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Flowood, Mississippi 39232
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St Louis, Missouri 63123
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Las Vegas, Nevada 89106
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Freehold, New Jersey 07728
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Warren Township, New Jersey 07059
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Albuquerque, New Mexico 87109
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Albany, New York 12206
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Carmel, New York 10512
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New York, New York 10021
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Charlotte, North Carolina 28207
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Durham, North Carolina 27710
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Fayetteville, North Carolina 28304
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Morehead City, North Carolina 28557
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Raleigh, North Carolina 27612
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Wilmington, North Carolina 28401
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Winston-Salem, North Carolina 27103
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Akron, Ohio 44320
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Cleveland, Ohio 44106
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Dayton, Ohio 45145
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Dayton, Ohio 45414
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Liberty Township, Ohio 45044
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Columbia, South Carolina 29204
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Chattanooga, Tennessee 37421
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Cordova, Tennessee 38018
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Hermitage, Tennessee 37076
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Nashville, Tennessee 37211
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Amarillo, Texas 79106
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Austin, Texas 78745
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Austin, Texas 78757-8051
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Bellaire, Texas 77401
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Brownsville, Texas 78520
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Denton, Texas 76201
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Edinburg, Texas 78539
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Farmers Branch, Texas 75234
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Fort Worth, Texas 76104
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Garland, Texas 75044
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Georgetown, Texas 78626
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Georgetown, Texas 78628
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Houston, Texas 77030
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Houston, Texas 77090
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Houston, Texas 77099
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Katy, Texas 77494
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Lewisville, Texas 75067
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Lubbock, Texas 79424
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San Antonio, Texas 78209
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San Antonio, Texas 78215
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San Antonio, Texas 78222
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San Antonio, Texas 78229-4801
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San Antonio, Texas 78229
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Southlake, Texas 76092
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Stafford, Texas 77477
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Sugar Land, Texas 77479
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Tomball, Texas 77584
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Tyler, Texas 75701
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Ogden, Utah 84405
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Richmond, Virginia 23226-1925
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Richmond, Virginia 23236
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San Juan, Puerto Rico 00927
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More Details

Status
Recruiting
Sponsor
89bio, Inc.

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.