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Purpose

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]).

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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).

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.

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
  • Biological: Pegozafermin
    Subcutaneous injection
    Other names:
    • BIO89-100
Placebo Comparator
Placebo 		Matched placebo
  • Drug: Placebo
    Subcutaneous injection

Recruiting Locations

89bio Clinical Study Site
Birmingham, Alabama 35205
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Homewood, Alabama 35209
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89bio Clinical Study Site
Chandler, Arizona 85224
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Peoria, Arizona 85381
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89bio Clinical Study Site
Phoenix, Arizona 85054
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89bio Clinical Study Site
Sun City, Arizona 85351
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89bio Clinical Study Site
Tucson, Arizona 85712
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89bio Clinical Study Site
Tucson, Arizona 85715
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89bio Clinical Study Site
Tucson, Arizona 85716
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89bio Clinical Study Site
Little Rock, Arkansas 72205
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89bio Clinical Study Site
North Little Rock, Arkansas 72117
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Camarillo, California 93012
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Canoga Park, California 91304
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Coronado, California 92118
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89bio Clinical Study Site
Fountain Valley, California 92708
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Fresno, California 93720
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89bio Clinical Study Site
La Jolla, California 92037-0887
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89bio Clinical Study Site
Los Angeles, California 90033
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89bio Clinical Study Site
Los Angeles, California 90048
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89bio Clinical Study Site
Pasadena, California 91105
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Poway, California 92064
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89bio Clinical Study Site
Redwood City, California 94063
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89bio Clinical Study Site
Rialto, California 92377
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Sacramento, California 95817
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89bio Clinical Study Site
Littleton, Colorado 80120
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Clermont, Florida 34711
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Fort Myers, Florida 33912
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89bio Clinical Study Site
Gainesville, Florida 32610
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Hialeah Gardens, Florida 33016
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89bio Clinical Study Site
Homestead, Florida 33030
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Jacksonville, Florida 32224
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Jacksonville, Florida 32256
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Lakewood Rch, Florida 34211
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Lehigh Acres, Florida 33936
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89bio Clinical Study Site
Maitland, Florida 32751
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Miami, Florida 33144
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Miami, Florida 33176-1530
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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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University Park, Florida 34201
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Viera, Florida 32940
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Winter Park, Florida 32789
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Athens, Georgia 30607
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Atlanta, Georgia 30309
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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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Kansas City, Kansas 66160
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Topeka, Kansas 66606
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Louisville, Kentucky 40218
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Lafayette, Louisiana 70503
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Lake Charles, Louisiana 70605
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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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Ann Arbor, Michigan 48109
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Clinton Township, Michigan 48038
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Detroit, Michigan 48202
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Wyoming, Michigan 49519
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Ypsilanti, Michigan 48197
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Minneapolis, Minnesota 55413
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Rochester, Minnesota 55905
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Flowood, Mississippi 39232
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St Louis, Missouri 63110
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St Louis, Missouri 63123
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Las Vegas, Nevada 89106
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Somers Point, New Jersey 08244
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Albuquerque, New Mexico 87109
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New York, New York 10016
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New York, New York 10021
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Asheville, North Carolina 28801
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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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Winston-Salem, North Carolina 27103
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Akron, Ohio 44320
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Cincinnati, Ohio 45267
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Cleveland, Ohio 44106
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Columbus, Ohio 43210
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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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Westlake, Ohio 44145
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Philadelphia, Pennsylvania 19148
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Pittsburgh, Pennsylvania 15213
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East Greenwich, Rhode Island 02818
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Charleston, South Carolina 29425
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Columbia, South Carolina 29204
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Rapid City, South Dakota 57701
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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 78757-8059
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Austin, Texas 78757-8066
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Brownsville, Texas 78520
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DeSoto, Texas 75115
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Farmers Branch, Texas 75234
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Fort Worth, Texas 76104
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Georgetown, Texas 78628
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Harlingen, Texas 78550
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Houston, Texas 77030
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Houston, Texas 77074
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Houston, Texas 77090
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Houston, Texas 77099
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Lewisville, Texas 75067
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Lubbock, Texas 79410
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Lubbock, Texas 79424
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Mansfield, Texas 76063
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Pearland, Texas 77584
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San Antonio, Texas 78209
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San Antonio, Texas 78229-4801
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San Antonio, Texas 78229-5069
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San Marcos, Texas 78666
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Southlake, Texas 76092
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Tyler, Texas 75701
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Waco, Texas 76710
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Waco, Texas 76712
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Sandy City, Utah 84092
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West Jordan, Utah 84088
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Richmond, Virginia 23226
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Richmond, Virginia 23236
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Richmond, Virginia 23298
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Bellevue, Washington 98004
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Seattle, Washington 98101
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Seattle, Washington 98105
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Tacoma, Washington 98405
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Manati, Puerto Rico 00674
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Mayagüez, Puerto Rico 00680
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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.