Evaluating Pegozafermin for Liver Disease in Patients with Compensated Cirrhosis
Official title: A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Compensated Cirrhosis Due to Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ENLIGHTEN-Cirrhosis)
Run by Hoffmann-La Roche · NCT06419374 · Data updated 2026-11-12
This study is testing if a new treatment called pegozafermin can improve liver health in people with compensated cirrhosis caused by metabolic issues.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 1800 (estimated) |
| Sponsor | Hoffmann-La Roche Industry-sponsored |
| Locations | 330 sites (Birmingham, Alabama and 329 other locations) |
| Status | Recruiting |
| Started | May 24, 2024 |
| Main results expected | June 30, 2028 |
| Study ends | August 31, 2031 |
| Registry record updated | October 23, 2026 |
| Trial ID | NCT06419374 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are males or non-pregnant females aged 18 to 75 with biopsy-confirmed F4 MASH and at least one metabolic risk factor.
✕Probably not a fit
Patients with liver disorders other than MASH or those with a history of hepatic decompensation or hepatocellular carcinoma may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the efficacy and safety of pegozafermin in participants diagnosed with compensated cirrhosis due to metabolic dysfunction-associated steatohepatitis (MASH). Participants must have biopsy-confirmed fibrosis stage F4 MASH and at least one metabolic risk factor. The study involves administering either pegozafermin or a placebo to assess its impact on liver health. The trial aims to provide insights into potential new treatments for this serious liver condition.
Why it matters
Potential benefit: If successful, this treatment could significantly improve liver health and quality of life for patients with compensated cirrhosis due to MASH.
How similar studies have gone: While this approach is focused on a specific patient population, similar studies targeting liver diseases have shown promising results, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
89bio Clinical Study Site
Birmingham, Alabama, United States Recruiting -
89bio Clinical Study Site
Homewood, Alabama, United States Recruiting -
89bio Clinical Study Site
Chandler, Arizona, United States Recruiting -
89bio Clinical Study Site
Peoria, Arizona, United States Recruiting -
89bio Clinical Study Site
Phoenix, Arizona, United States Recruiting -
89bio Clinical Study Site
Sun City, Arizona, United States Recruiting
Show 44 more locations
-
89bio Clinical Study Site
Tucson, Arizona, United States Recruiting -
89bio Clinical Study Site
Tucson, Arizona, United States Recruiting -
89bio Clinical Study Site
Tucson, Arizona, United States Recruiting -
89bio Clinical Study Site
Little Rock, Arkansas, United States Recruiting -
89bio Clinical Study Site
North Little Rock, Arkansas, United States Recruiting -
89bio Clinical Study Site
Camarillo, California, United States Recruiting -
89bio Clinical Study Site
Canoga Park, California, United States Recruiting -
89bio Clinical Study Site
Coronado, California, United States Recruiting -
89bio Clinical Study Site
Fountain Valley, California, United States Recruiting -
89bio Clinical Study Site
Fresno, California, United States Recruiting -
89bio Clinical Study Site
La Jolla, California, United States Recruiting -
89bio Clinical Study Site
Los Angeles, California, United States Recruiting -
89bio Clinical Study Site
Los Angeles, California, United States Recruiting -
89bio Clinical Study Site
Pasadena, California, United States Recruiting -
89bio Clinical Study Site
Poway, California, United States Recruiting -
89bio Clinical Study Site
Redwood City, California, United States Recruiting -
89bio Clinical Study Site
Rialto, California, United States Recruiting -
89bio Clinical Study Site
Sacramento, California, United States Recruiting -
89bio Clinical Study Site
Littleton, Colorado, United States Recruiting -
89bio Clinical Study Site
Clermont, Florida, United States Recruiting -
89bio Clinical Study Site
Fort Myers, Florida, United States Recruiting -
89bio Clinical Study Site
Gainesville, Florida, United States Recruiting -
89bio Clinical Study Site
Hialeah Gardens, Florida, United States Recruiting -
89bio Clinical Study Site
Homestead, Florida, United States Recruiting -
89bio Clinical Study Site
Jacksonville, Florida, United States Recruiting -
89bio Clinical Study Site
Jacksonville, Florida, United States Recruiting -
89bio Clinical Study Site
Lakewood Rch, Florida, United States Recruiting -
89bio Clinical Study Site
Lehigh Acres, Florida, United States Recruiting -
89bio Clinical Study Site
Miami, Florida, United States Recruiting -
89bio Clinical Study Site
Miami, Florida, United States Recruiting -
89bio Clinical Study Site
Miami, Florida, United States Recruiting -
89bio Clinical Study Site
New Port Richey, Florida, United States Recruiting -
89bio Clinical Study Site
Ocala, Florida, United States Recruiting -
89bio Clinical Study Site
Ocoee, Florida, United States Recruiting -
89bio Clinical Study Site
University Park, Florida, United States Recruiting -
89bio Clinical Study Site
Viera, Florida, United States Recruiting -
89bio Clinical Study Site
Winter Park, Florida, United States Recruiting -
89bio Clinical Study Site
Athens, Georgia, United States Recruiting -
89bio Clinical Study Site
Atlanta, Georgia, United States Recruiting -
89bio Clinical Study Site
Marietta, Georgia, United States Recruiting -
89bio Clinical Study Site
Chicago, Illinois, United States Recruiting -
89bio Clinical Study Site
Glenview, Illinois, United States Recruiting -
89bio Clinical Study Site
Hammond, Indiana, United States Recruiting -
89bio Clinical Study Site
New Albany, Indiana, United States Recruiting
+280 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Reference Study ID Number: BIO89-100-132 / GC46898 ENLIGHTEN clinical trial / No attachments to email below.
- Email: global-roche-genentech-trials@gene.com
- Phone: 888-662-6728 (U.S. Only)
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.