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

RECRUITINGPhase 3Sponsored by 89bio, Inc.
Actively Recruiting
PhasePhase 3
Sponsor89bio, Inc.
Started2024-03-13
Est. completion2029-02
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted
Locations129 sites
View on ClinicalTrials.gov →

NCT06318169

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

Age: 18 Years – 80 YearsHealthy volunteers accepted
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.

Conditions2

Liver DiseaseMetabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis

Locations129 sites

89bio Clinical Study Site
Birmingham, Alabama, 35209
89bio Clinical Study Site
89bio Clinical Study Site
Chandler, Arizona, 85224
89bio Clinical Study Site
89bio Clinical Study Site
Flagstaff, Arizona, 86001
89bio Clinical Study Site
89bio Clinical Study Site
Glendale, Arizona, 85036
89bio Clinical Study Site
89bio Clinical Study Site
Tucson, Arizona, 85712
89bio Clinical Study Site

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