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

Description

The study will assess the efficacy and safety of 2 dose regimens of pegozafermin for the treatment of liver fibrosis stage 2 or 3 in adult participants with MASH (previously known as nonalcoholic steatohepatitis \[NASH\]).

Conditions

Metabolic Dysfunction-associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) with Fibrosis

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Study Overview

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Study Details

Study overview

The study will assess the efficacy and safety of 2 dose regimens of pegozafermin for the treatment of liver fibrosis stage 2 or 3 in adult participants with MASH (previously known as nonalcoholic steatohepatitis \[NASH\]).

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

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

Condition
Metabolic Dysfunction-associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) with Fibrosis
Intervention / Treatment

-

Contacts and Locations

Birmingham

89bio Clinical Study Site, Birmingham, Alabama, United States, 35209

Chandler

89bio Clinical Study Site, Chandler, Arizona, United States, 85224

Flagstaff

89bio Clinical Study Site, Flagstaff, Arizona, United States, 86001

Glendale

89bio Clinical Study Site, Glendale, Arizona, United States, 85036

Tucson

89bio Clinical Study Site, Tucson, Arizona, United States, 85712

Conway

89bio Clinical Study Site, Conway, Arkansas, United States, 72032

Little Rock

89bio Clinical Study Site, Little Rock, Arkansas, United States, 72211-3859

North Little Rock

89bio Clinical Study Site, North Little Rock, Arkansas, United States, 72117

Canoga Park

89bio Clinical Study Site, Canoga Park, California, United States, 91604

Fountain Valley

89bio Clinical Study Site, Fountain Valley, California, United States, 92708

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Males or non-pregnant females aged between 18 and 75 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 CRN System and NAS ≥4, with a score of at least 1 in each of steatosis, ballooning degeneration, and lobular inflammation (qualifying biopsy must be either within 6 months of screening visit \[with additional requirements\] or obtained during screening period)
  • * Body mass index (BMI) at screening ≥25.0 (≥23 for Asian participants) and \<50.0 kilograms (kg)/meters squared (m\^2)
  • * Chronic liver diseases other than MASH/NASH
  • * History or 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) must be on stable dose for at least 6 months prior to screening

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

89bio, Inc.,

Millie Gottwald, PharmD, STUDY_DIRECTOR, 89bio, Inc.

Study Record Dates

2029-02