89bio_BIO89-100-131_The ENLIGHTEN-Fibrosis Study

What is the Purpose of this Study?

Primary Opjective: To evaluate the effect of pegozafermin compared to placebo on liver histology at 52 weeks relative to baseline biopsy Key Secondary Objective: To evaluate the effect of pegozafermin compared to placebo on liver-related noninvasive tests (NITs) at 52 weeks Secondary objectives: To evaluate the effect of pegozafermin compared to placebo on additional liver histology endpoints at 52 weeks relative to baseline biopsy To evaluate the effect of pegozafermin compared to placebo on additional NITs at 52 weeks To evaluate the metabolic effects of pegozafermin compared to placebo at 52 weeks To evaluate the safety and tolerability of pegozafermin compared to placebo after 52 weeks of treatment Exploratory objectives: To evaluate the effect of pegozafermin compared to placebo on additional clinical parameters, including histology, imaging assessments, anthropometric assessment, and laboratory parameters at 52 weeks To evaluate the effects of pegozafermin on patient reported outcomes (PROs) from baseline to 52 weeks To evaluate the pharmacokinetics (PK) of pegozafermin over 52 weeks of treatment To evaluate additional safety and tolerability profile of pegozafermin over 52 weeks of treatment To evaluate the effect of pegozafermin on blood pressure and pulse rate after 48 weeks of treatment (Ambulatory Blood Pressure Monitoring [ABPM] substudy) To characterize the immunogenicity of pegozafermin after 52 weeks of treatment To evaluate the molecular data (e.g., proteomics, genomics) to increase the understanding of pegozafermin biological activity, and to identify potential existing and/or emerging biomarkers


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