Recruiting
Phase 3

Pegozafermin

Sponsor:

89bio, Inc.

Code:

NCT06318169

Conditions

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

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Pegozafermin

Placebo

Study Details

Brief summary:

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.

Conditions

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

Study ID

NCT06318169

Start date

Mar 13, 2024

Status verified date

Sep, 2026

Completion date

Feb, 2029

Anticipated

Primary completion date

Feb, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Key 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).

Key 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

Enrollment

1350 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Pegozafermin Regimen 1

experimental: Pegozafermin Regimen 2

placebo comparator: Placebo

Matched Placebo will be administered in Regimens 1 and 2.

Interventions

Pegozafermin

Subcutaneous injection

Placebo

Subcutaneous injection

Primary outcome measure

  • Number of Participants With at Least an Improvement of Fibrosis ≥1 Stage Without Worsening of Steatohepatitis at Week 52 [ Time Frame: Week 52 ]
  • Number of Participants With Resolution of Steatohepatitis Without Worsening of Fibrosis at Week 52 [ Time Frame: Week 52 ]
  • Time to First Occurrence of Disease Progression [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Central contacts

Reference Study ID Number: BIO89-100-131 ENLIGHTEN clinical trial / No attachments to email below.

888-662-6728 (U.S. Only)global-roche-genentech-trials@gene.com

Locations

89bio Clinical Study Site

Recruiting

Birmingham, Alabama, United States, 35209

89bio Clinical Study Site

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Chandler, Arizona, United States, 85224

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Glendale, Arizona, United States, 85036

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Sun City, Arizona, United States, 85351

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Tucson, Arizona, United States, 85712-4018

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Tucson, Arizona, United States, 85716

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Little Rock, Arkansas, United States, 72211-3859

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North Little Rock, Arkansas, United States, 72117

89bio Clinical Study Site

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Canoga Park, California, United States, 91604

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Coronado, California, United States, 92118

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Escondido, California, United States, 92025

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Fountain Valley, California, United States, 92708

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Fresno, California, United States, 93720

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Gardena, California, United States, 90247

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La Jolla, California, United States, 92037

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Lancaster, California, United States, 93534

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Long Beach, California, United States, 90815

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Montclair, California, United States, 91763

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Orange, California, United States, 92868

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Pasadena, California, United States, 91105

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Poway, California, United States, 92064

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Rialto, California, United States, 92377

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Stanford, California, United States, 94305

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Victorville, California, United States, 92395

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Littleton, Colorado, United States, 80120

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Brandon, Florida, United States, 33511

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Clermont, Florida, United States, 34711

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Fort Myers, Florida, United States, 33912

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Hialeah Gardens, Florida, United States, 33016

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Homestead, Florida, United States, 33030

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Jacksonville, Florida, United States, 32256

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Jupiter, Florida, United States, 33458

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Lady Lake, Florida, United States, 32159-6831

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Lakewood Rch, Florida, United States, 34211

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Lehigh Acres, Florida, United States, 33936

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Maitland, Florida, United States, 32751-7258

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Maitland, Florida, United States, 32751-7497

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Miami, Florida, United States, 33176

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New Port Richey, Florida, United States, 34653

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Ocala, Florida, United States, 34471

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Ocoee, Florida, United States, 34761

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Sarasota, Florida, United States, 34240

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Winter Park, Florida, United States, 32789

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Athens, Georgia, United States, 30607

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Dalton, Georgia, United States, 30720

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Marietta, Georgia, United States, 30060

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Chicago, Illinois, United States, 60611

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Hammond, Indiana, United States, 46324

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New Albany, Indiana, United States, 47150

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South Bend, Indiana, United States, 46635

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Iowa City, Iowa, United States, 52242

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Topeka, Kansas, United States, 66606

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Louisville, Kentucky, United States, 40218

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Covington, Louisiana, United States, 70433

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Houma, Louisiana, United States, 70360

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Lake Charles, Louisiana, United States, 70605

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Marrero, Louisiana, United States, 70072

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West Monroe, Louisiana, United States, 71291

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Baltimore, Maryland, United States, 21202

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Glen Burnie, Maryland, United States, 21061

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Greenbelt, Maryland, United States, 20770

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Burlington, Massachusetts, United States, 01805

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Chesterfield, Michigan, United States, 48047

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Wyoming, Michigan, United States, 49519

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Ypsilanti, Michigan, United States, 48197

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Maplewood, Minnesota, United States, 55109

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Rochester, Minnesota, United States, 55905

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Flowood, Mississippi, United States, 39232

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St Louis, Missouri, United States, 63123

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Las Vegas, Nevada, United States, 89106

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Freehold, New Jersey, United States, 07728

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Warren Township, New Jersey, United States, 07059

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Albuquerque, New Mexico, United States, 87109

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Albany, New York, United States, 12206

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Carmel, New York, United States, 10512

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New York, New York, United States, 10021

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Charlotte, North Carolina, United States, 28207

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Durham, North Carolina, United States, 27710

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Fayetteville, North Carolina, United States, 28304

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Raleigh, North Carolina, United States, 27612

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Wilmington, North Carolina, United States, 28401

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Winston-Salem, North Carolina, United States, 27103

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Akron, Ohio, United States, 44320

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Dayton, Ohio, United States, 45145

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Dayton, Ohio, United States, 45414

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Liberty Township, Ohio, United States, 45044

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Lima, Ohio, United States, 45801

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Springboro, Ohio, United States, 45066

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Westlake, Ohio, United States, 44145

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East Greenwich, Rhode Island, United States, 02818

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Charleston, South Carolina, United States, 29425

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Columbia, South Carolina, United States, 29204

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Chattanooga, Tennessee, United States, 37421

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Cordova, Tennessee, United States, 38018

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Hermitage, Tennessee, United States, 37076

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Nashville, Tennessee, United States, 37211

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Amarillo, Texas, United States, 79106

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Austin, Texas, United States, 78745

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Austin, Texas, United States, 78757-8051

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Austin, Texas, United States, 78757

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Bellaire, Texas, United States, 77401

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Brownsville, Texas, United States, 78520

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Corpus Christi, Texas, United States, 78404

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Denton, Texas, United States, 76201

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DeSoto, Texas, United States, 75115

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Edinburg, Texas, United States, 78539

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Farmers Branch, Texas, United States, 75234

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Fort Worth, Texas, United States, 76104

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Garland, Texas, United States, 75044

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Georgetown, Texas, United States, 78626

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Georgetown, Texas, United States, 78628

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Houston, Texas, United States, 77030

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Houston, Texas, United States, 77090

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Houston, Texas, United States, 77099

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Katy, Texas, United States, 77494

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Lewisville, Texas, United States, 75067

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Lubbock, Texas, United States, 79424

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San Antonio, Texas, United States, 78209

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San Antonio, Texas, United States, 78215

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San Antonio, Texas, United States, 78222

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San Antonio, Texas, United States, 78229-4801

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San Antonio, Texas, United States, 78229

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Southlake, Texas, United States, 76092

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Stafford, Texas, United States, 77477

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Sugar Land, Texas, United States, 77479

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Tomball, Texas, United States, 77584

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Tyler, Texas, United States, 75701

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Waco, Texas, United States, 76301

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Waco, Texas, United States, 76710

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Ogden, Utah, United States, 84405

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Richmond, Virginia, United States, 23226-1925

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Richmond, Virginia, United States, 23236

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Richmond, Virginia, United States, 23298

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Roanoke, Virginia, United States, 24014

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Bellevue, Washington, United States, 98004

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Seattle, Washington, United States, 98101

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Seattle, Washington, United States, 98105

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Tacoma, Washington, United States, 98405

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Calgary, Alberta, Canada, T2N 4Z6

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Vancouver, British Columbia, Canada, V5Z 1M9

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Vancouver, British Columbia, Canada, V6Z2K5

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Winnipeg, Manitoba, Canada, R3T 2N2

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London, Ontario, Canada, N6A 5A5

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Ottawa, Ontario, Canada, K1H8L6

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Toronto, Ontario, Canada, M5G2C4

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Toronto, Ontario, Canada, M6H 3M1

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Vaughan, Ontario, Canada, L4L 4Y7

More Information

Sponsor

89bio, Inc.

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Keywords

  • Liver Diseases
  • Fatty Liver
  • Digestive System Diseases
  • Metabolic diseases
  • Metabolic Dysfunction-Associated Steatohepatitis
  • MASH
  • Steatohepatitis
  • Metabolic dysfunction-associated steatotic liver disease
  • MASLD
  • Nonalcoholic fatty liver disease
  • NAFLD
  • Fibrosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-05. This information was provided to ClinicalTrials.gov by 89bio, Inc. on 2026-09-03.