A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)

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

  • Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis

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
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Chandler, Arizona 85224
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Flagstaff, Arizona 86001
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Glendale, Arizona 85036
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Tucson, Arizona 85712
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Little Rock, Arkansas 72211-3859
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
North Little Rock, Arkansas 72117
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Canoga Park, California 91604
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Coronado, California 92118
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Fountain Valley, California 92708
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Fresno, California 93720
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Gardena, California 90247
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Inglewood, California 90301
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
La Jolla, California 92037
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Lancaster, California 93534
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Long Beach, California 90815
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Los Angeles, California 90048
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Montclair, California 91763
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Orange, California 92868
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Panorama City, California 91402
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Pasadena, California 91105
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Poway, California 92064
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Rialto, California 92377
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Stanford, California 94305
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Victorville, California 92395
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Colorado Springs, Colorado 80923
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Littleton, Colorado 80120
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Brandon, Florida 33511
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Clermont, Florida 34711
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Fort Myers, Florida 33912
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Hialeah Gardens, Florida 33016
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Homestead, Florida 33030
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Jacksonville, Florida 32256
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Jupiter, Florida 33458
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Lady Lake, Florida 32159-6831
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Lakewood Rch, Florida 34211
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Lehigh Acres, Florida 33936
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Maitland, Florida 32751-7258
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Maitland, Florida 32751-7497
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
New Port Richey, Florida 34653
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Ocala, Florida 34471
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Ocoee, Florida 34761
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Sarasota, Florida 34240
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Winter Park, Florida 32789
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Athens, Georgia 30607
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Dalton, Georgia 30720
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Chicago, Illinois 60611
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Hammond, Indiana 46324
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
New Albany, Indiana 47150
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
South Bend, Indiana 46635
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Iowa City, Iowa 52242
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Topeka, Kansas 66606
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Covington, Louisiana 70433
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Houma, Louisiana 70360
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Lake Charles, Louisiana 70605
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Marrero, Louisiana 70072
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
New Orleans, Louisiana 70115
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
West Monroe, Louisiana 71291
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Baltimore, Maryland 21202
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Glen Burnie, Maryland 21061
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Greenbelt, Maryland 20770
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Burlington, Massachusetts 01805
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Chesterfield, Michigan 48047
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Wyoming, Michigan 49519
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Ypsilanti, Michigan 48197
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Rochester, Minnesota 55905
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Flowood, Mississippi 39232
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
St Louis, Missouri 63123
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Las Vegas, Nevada 89106
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Freehold, New Jersey 07728
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Warren Township, New Jersey 07059
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Albuquerque, New Mexico 87109
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Carmel, New York 10512
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
New York, New York 10021
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Charlotte, North Carolina 28207
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Durham, North Carolina 27710
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Fayetteville, North Carolina 28304
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Morehead City, North Carolina 28557
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Raleigh, North Carolina 27612
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Winston-Salem, North Carolina 27103
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Akron, Ohio 44320
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Cleveland, Ohio 44106
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Dayton, Ohio 45414
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Liberty Township, Ohio 45044
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Lima, Ohio 45801
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Springboro, Ohio 45066
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Westlake, Ohio 44145
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
East Greenwich, Rhode Island 02818
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Charleston, South Carolina 29425
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Columbia, South Carolina 29204
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Chattanooga, Tennessee 37421
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Cordova, Tennessee 38018
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Hermitage, Tennessee 37076
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Nashville, Tennessee 37211
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Amarillo, Texas 79106
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Austin, Texas 78745
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Austin, Texas 78757-8051
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Austin, Texas 78757
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Bellaire, Texas 77401
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Brownsville, Texas 78520
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Corpus Christi, Texas 78404
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
DeSoto, Texas 75115
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Edinburg, Texas 78539
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Farmers Branch, Texas 75234
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Fort Worth, Texas 76104
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Garland, Texas 75044
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Georgetown, Texas 78626
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Georgetown, Texas 78628
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Houston, Texas 77030
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Houston, Texas 77099
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Katy, Texas 77494
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
San Antonio, Texas 78209
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
San Antonio, Texas 78215
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
San Antonio, Texas 78222
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
San Antonio, Texas 78229-4801
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
San Antonio, Texas 78229
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Stafford, Texas 77477
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Tomball, Texas 77584
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Waco, Texas 76301
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Waco, Texas 76710
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Ogden, Utah 84405
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Richmond, Virginia 23226-1925
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Richmond, Virginia 23236
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Richmond, Virginia 23298
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Roanoke, Virginia 24014
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Seattle, Washington 98101
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Seattle, Washington 98105
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Manati, Puerto Rico 00674
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
Mayagüez, Puerto Rico 00680
Contact:
89bio Clinical Study Site

89bio Clinical Study Site
San Juan, Puerto Rico 00927
Contact:
89bio Clinical Study Site

More Details

NCT ID
NCT06318169
Status
Recruiting
Sponsor
89bio, Inc.

Study Contact

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

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center