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RecruitingPhase 3

A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH

Hoffmann-La Roche · NCT06419374

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–75 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
1800
US sites recruiting
131
Study start
May 24, 2024
Record last updated
October 23, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

The study will assess the efficacy and safety of pegozafermin administered in participants with biopsy-confirmed and clinically confirmed compensated cirrhosis due to MASH .

Being studied: Pegozafermin; Placebo

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

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.
  • Evidence of both cirrhosis and MASH etiology, either through a historical biopsy or a biopsy at Screening.
  • Clinical diagnosis of cirrhosis based on the NIT algorithm.

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.

Recruiting US locations

  • 89bio Clinical Study Site

    Birmingham, AL 35205

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Homewood, AL 35209

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Chandler, AZ 85224

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Peoria, AZ 85381

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Phoenix, AZ 85054

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Sun City, AZ 85351

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Tucson, AZ 85712

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Tucson, AZ 85715

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Tucson, AZ 85716

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Little Rock, AR 72205

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    North Little Rock, AR 72117

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Camarillo, CA 93012

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Canoga Park, CA 91304

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Coronado, CA 92118

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Fountain Valley, CA 92708

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Fresno, CA 93720

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    La Jolla, CA 92037-0887

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Los Angeles, CA 90033

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Los Angeles, CA 90048

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Pasadena, CA 91105

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Poway, CA 92064

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Redwood City, CA 94063

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Rialto, CA 92377

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Sacramento, CA 95817

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Littleton, CO 80120

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Clermont, FL 34711

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Fort Myers, FL 33912

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Gainesville, FL 32610

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Hialeah Gardens, FL 33016

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Homestead, FL 33030

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Jacksonville, FL 32224

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Jacksonville, FL 32256

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Lakewood Rch, FL 34211

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Lehigh Acres, FL 33936

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Miami, FL 33144

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Miami, FL 33176-1530

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Miami, FL 33176

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    New Port Richey, FL 34653

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Ocala, FL 34471

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Ocoee, FL 34761

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    University Park, FL 34201

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Viera, FL 32940

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Winter Park, FL 32789

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Athens, GA 30607

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Atlanta, GA 30309

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Marietta, GA 30060

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Chicago, IL 60611

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Glenview, IL 60026

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Hammond, IN 46324

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    New Albany, IN 47150

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    South Bend, IN 46635

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Iowa City, IA 52242

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Kansas City, KS 66160

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Topeka, KS 66606

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Louisville, KY 40218

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Lafayette, LA 70503

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Lake Charles, LA 70605

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    West Monroe, LA 71291

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Baltimore, MD 21202

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Glen Burnie, MD 21061

    Site contact: 89bio Clinical Study Site

+ 71 more on the official record.

Study contacts (from the official record)

  • Reference Study ID Number: BIO89-100-132 / GC46898 ENLIGHTEN clinical trial / No attachments to email below. · 888-662-6728 (U.S. Only) · global-roche-genentech-trials@gene.com
  • Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
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A Study to Evaluate the Efficacy and Safety of Pegozafermin in… (NCT06419374) | Bored Studies