Recruiting
Phase 3

Pegozafermin

Sponsor:

89bio, Inc.

Code:

NCT06419374

Conditions

Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis

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 pegozafermin administered in participants with compensated cirrhosis due to MASH (biopsy-confirmed fibrosis stage F4 MASH \[previously known as nonalcoholic steatohepatitis, NASH\]).

Conditions

Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis

Study ID

NCT06419374

Start date

May 24, 2024

Status verified date

Sep, 2026

Completion date

Aug, 2031

Anticipated

Primary completion date

Jun, 2028

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 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).

Key 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

Enrollment

762 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Pegozafermin

placebo comparator: Placebo

Matched placebo

Interventions

Pegozafermin

Subcutaneous injection

Placebo

Subcutaneous injection

Primary outcome measure

  • Proportion of Participants Achieving Fibrosis Regression [ Time Frame: Baseline through Month 24 ]
  • Time to First Occurrence of Disease Progression as Measured by Composite of Protocol -Specified Clinical Events [ Time Frame: Baseline up to 5 years ]

Central Contacts and Locations

Central contacts

Reference Study ID Number: BIO89-100-132 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, 35205

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Homewood, Alabama, United States, 35209

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Chandler, Arizona, United States, 85224

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Peoria, Arizona, United States, 85381

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Phoenix, Arizona, United States, 85054

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Sun City, Arizona, United States, 85351

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Tucson, Arizona, United States, 85712

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Tucson, Arizona, United States, 85715

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Tucson, Arizona, United States, 85716

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Little Rock, Arkansas, United States, 72205

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North Little Rock, Arkansas, United States, 72117

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Camarillo, California, United States, 93012

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Canoga Park, California, United States, 91304

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Coronado, California, United States, 92118

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Fountain Valley, California, United States, 92708

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Fresno, California, United States, 93720

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La Jolla, California, United States, 92037-0887

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Los Angeles, California, United States, 90033

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Los Angeles, California, United States, 90048

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Pasadena, California, United States, 91105

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Poway, California, United States, 92064

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Redwood City, California, United States, 94063

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Rialto, California, United States, 92377

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Sacramento, California, United States, 95817

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Littleton, Colorado, United States, 80120

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Clermont, Florida, United States, 34711

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Fort Myers, Florida, United States, 33912

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Gainesville, Florida, United States, 32610

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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, 32224

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Jacksonville, Florida, United States, 32256

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Lakewood Rch, Florida, United States, 34211

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Lehigh Acres, Florida, United States, 33936

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Miami, Florida, United States, 33144

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Miami, Florida, United States, 33176-1530

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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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University Park, Florida, United States, 34201

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Viera, Florida, United States, 32940

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Winter Park, Florida, United States, 32789

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Athens, Georgia, United States, 30607

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Atlanta, Georgia, United States, 30309

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Chicago, Illinois, United States, 60611

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Glenview, Illinois, United States, 60026

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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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Kansas City, Kansas, United States, 66160

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Topeka, Kansas, United States, 66606

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Louisville, Kentucky, United States, 40218

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Lafayette, Louisiana, United States, 70503

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Lake Charles, Louisiana, United States, 70605

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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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Framingham, Massachusetts, United States, 01702

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Ann Arbor, Michigan, United States, 48109

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Clinton Township, Michigan, United States, 48038

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Detroit, Michigan, United States, 48202

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Wyoming, Michigan, United States, 49519

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Ypsilanti, Michigan, United States, 48197

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Minneapolis, Minnesota, United States, 55413

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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, 63110

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St Louis, Missouri, United States, 63123

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Las Vegas, Nevada, United States, 89106

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Somers Point, New Jersey, United States, 08244

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Albuquerque, New Mexico, United States, 87109

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Albany, New York, United States, 12206

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New York, New York, United States, 10016

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New York, New York, United States, 10021

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Asheville, North Carolina, United States, 28801

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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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Winston-Salem, North Carolina, United States, 27103

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Akron, Ohio, United States, 44320

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Cincinnati, Ohio, United States, 45267

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Cleveland, Ohio, United States, 44106

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Columbus, Ohio, United States, 43210

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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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Westlake, Ohio, United States, 44145

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Philadelphia, Pennsylvania, United States, 19148

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Pittsburgh, Pennsylvania, United States, 15213

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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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Rapid City, South Dakota, United States, 57701

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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, 78757-8059

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Austin, Texas, United States, 78757-8066

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Brownsville, Texas, United States, 78520

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DeSoto, Texas, United States, 75115

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Farmers Branch, Texas, United States, 75234

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Fort Worth, Texas, United States, 76104

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Georgetown, Texas, United States, 78628

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Harlingen, Texas, United States, 78550

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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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Lewisville, Texas, United States, 75067

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Lubbock, Texas, United States, 79424

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Mansfield, Texas, United States, 76063

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San Antonio, Texas, United States, 78209

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San Antonio, Texas, United States, 78229-4801

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San Antonio, Texas, United States, 78229-5069

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San Marcos, Texas, United States, 78666

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Southlake, Texas, United States, 76092

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Tyler, Texas, United States, 75701

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Waco, Texas, United States, 76710

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Waco, Texas, United States, 76712

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Sandy City, Utah, United States, 84092

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West Jordan, Utah, United States, 84088

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Richmond, Virginia, United States, 23226

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Richmond, Virginia, United States, 23236

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Richmond, Virginia, United States, 23298

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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, R3E 3P4

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London, Ontario, Canada, N6A5A5

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Ottawa, Ontario, Canada, K1H 8L6

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Toronto, Ontario, Canada, M6H3M1

More Information

Sponsor

89bio, Inc.

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-17. This information was provided to ClinicalTrials.gov by 89bio, Inc. on 2026-09-03.