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Bored Studies
RecruitingPhase 3

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

Hoffmann-La Roche · NCT06318169

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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 18–80 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
1350
US sites recruiting
136
Study start
March 13, 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 2 dose regimens of pegozafermin compared to placebo for the treatment of liver fibrosis stage F2 or F3 in adult participants with MASH.

Being studied: Pegozafermin; Placebo

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

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 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.

Recruiting US locations

  • 89bio Clinical Study Site

    Birmingham, 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

    Glendale, AZ 85036

    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 85712-4018

    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 72211-3859

    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

    Canoga Park, CA 91604

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Coronado, CA 92118

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Escondido, CA 92025

    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

    Gardena, CA 90247

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    La Jolla, CA 92037

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Lancaster, CA 93534

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Long Beach, CA 90815

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Montclair, CA 91763

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Orange, CA 92868

    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

    Rialto, CA 92377

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Stanford, CA 94305

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Victorville, CA 92395

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Littleton, CO 80120

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Brandon, FL 33511

    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

    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 32256

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Jupiter, FL 33458

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Lady Lake, FL 32159-6831

    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

    Maitland, FL 32751-7258

    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

    Sarasota, FL 34240

    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

    Dalton, GA 30720

    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

    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

    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

    Covington, LA 70433

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Houma, LA 70360

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Lake Charles, LA 70605

    Site contact: 89bio Clinical Study Site

  • 89bio Clinical Study Site

    Marrero, LA 70072

    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

  • 89bio Clinical Study Site

    Greenbelt, MD 20770

    Site contact: 89bio Clinical Study Site

+ 76 more on the official record.

Study contacts (from the official record)

  • 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
  • Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
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