NCT06318169 A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)
| NCT ID | NCT06318169 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | 89bio, Inc. |
| Condition | Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,350 participants |
| Start Date | 2024-03-13 |
| Primary Completion | 2029-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 1,350 participants in total. It began in 2024-03-13 with a primary completion date of 2029-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Reference Study ID Number: BIO89-100-131 ENLIGHTEN clinical trial / No attachments to email below.
✉ global-roche-genentech-trials@gene.com📞 888-662-6728 (U.S. Only)
Clinical Trials
STUDY DIRECTOR
89bio, Inc.
Frequently Asked Questions
Who can join the NCT06318169 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06318169 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,350 participants.
Is NCT06318169 currently recruiting?
Yes, NCT06318169 is actively recruiting participants. Contact the research team at global-roche-genentech-trials@gene.com for enrollment information.
Where is the NCT06318169 trial being conducted?
This trial is being conducted at Birmingham, United States, Chandler, United States, Flagstaff, United States, Glendale, United States and 11 additional locations.
Who is sponsoring the NCT06318169 clinical trial?
NCT06318169 is sponsored by 89bio, Inc.. The principal investigator is Clinical Trials at 89bio, Inc.. The trial plans to enroll 1,350 participants.