Pegozafermin in Metabolic Dysfunction-Associated Steatohepatitis and Fibrosis

What is the Purpose of this Study?

This study focuses on people who may have metabolic dysfunction-associated steatohepatitis (MASH), also called nonalcoholic steatohepatitis, that will be confirmed by a biopsy. The purpose of the study is to learn about the safety and effectiveness of an experimental drug called pegozafermin in patients with MASH when compared to a placebo (inactive substance) in assessing response to novel therapy in terms of improving inflammation and scar tissue in the liver (called fibrosis). Pegozafermin is a hormone made from protein that naturally occurs in the body and works on the metabolism of fats and glucose (sugar). Study procedures include blood draws, urine collection, liver biopsy, electrocardiograms, imaging, and scans. Another goal of the study is to learn the impact of pegozafermin on measures of organ function (such as blood cell counts, blood sugar, cholesterol and other blood fats, proteins, hormones, and bone production).


Eligibility

  • * Males or non-pregnant females aged between 18 and 80 years (inclusive) at time of signing the informed consent form (ICF)
  • * Biopsy-confirmed MASH (previously named NASH) with fibrosis stage F2 or F3 per NASH clinical research network (CRN) System and NAS ≥4, with a score of at least 1 in each of steatosis, ballooning degeneration, and lobular inflammation or NAS \<4 and/or a ballooning degradation score of 0 with fibrosis stage F3 and a score of at least 1 in steatosis. A historical biopsy must be within 6 months of screening visit (with additional requirements).
  • * Body mass index (BMI) at screening ≥25.0 kilograms (kg)/meters squared (m\^2) (≥23 kg/m\^2 for Asian countries)
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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects with Metabolic Dysfunction-Associated Steatohepatitis and Fibrosis.

Study Details
Disease Type/Condition

Other

Principal Investigator

Ayoub, Walid

Age Group

Adult

Phase

III

IRB Number

STUDY00003516

ClinicalTrials.gov ID

NCT06318169

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Other

Principal Investigator

Ayoub, Walid

Age Group

Adult

Phase

III

IRB Number

BIO89-100-131

ClinicalTrials.gov ID

NCT06318169

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org