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A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects with Compensated Cirrhosis due to Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Clinical Trial Details

The purpose of this study is to test if an investigational study drug, pegozafermin, is safe and effective in treating patients with compensated cirrhosis due to MASH metabolic dysfunction-associated steatohepatitis (MASH). 
   
MASH is the most severe form of nonalcoholic fatty liver disease (NAFLD) and is characterized by an excessive accumulation of fat in the liver, liver cell injury and inflammation, ultimately leading to fibrosis. Pegozafermin is being developed to reduce NASH and is experimental/Investigational, meaning it is not approved by the U.S. Food and Drug Administration (FDA). 

Participants will receive 30 mg tablet of Pegozafermin. All study participants will answer questionnaires, provide blood samples, fibroscan, and ultrasound.

Participation in this study will last for up to 12 months and participants will be compensated for their time.

Key Eligibility: 

1. Men and women who are 18 years of age and older.
2. Have been diagnosed with nonalcoholic fatty liver disease (NAFLD)
Detailed eligibility reviewed when contacting the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2412028273

ClinicalTrials.gov:

NCT06419374

Sponsor:

BIO89-100-132

Status

Open to Enrollment

Age Group

Adult

Sponsor