BIO89-100-131: A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects with Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

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 MASH metabolic dysfunction-associated steatohepatitis (MASH).

Investigational means that the drug has not been approved by regulatory authorities such as the U.S. Food and Drug Administration (FDA). 
   
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 MASH.
    
If an individual agrees to participate in this study and meets all the requirements, participants will be randomly assigned (like rolling dice) to one of three study groups: 
   a. Pegozafermin 30 mg (once weekly) 
   b. Pegozafermin 44 mg (once every two weeks) 
   c. Placebo (no active drug) once weekly or once every two weeks. 

Study participants will also answer questionnaires, provide blood samples, Fibroscan, X-Ray, Liver Biopsy, ultrasound, and optional blood pressure monitoring. 

Participation in this study will last for up to 40 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 Metabolic Dysfunction Associated Steatohepatitis (MASH) and Fibrosis.

Detailed eligibility will be 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 #:

2501028374

ClinicalTrials.gov:

NCT06318169

Sponsor:

BIO89-100-131

Status

Open to Enrollment

Age Group

Adult

Sponsor