A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants with Compensated Cirrhosis Due to MASH

Description

The study will assess the efficacy and safety of pegozafermin administered in participants with compensated cirrhosis due to MASH (biopsy-confirmed fibrosis stage F4 MASH \[previously known as nonalcoholic steatohepatitis, NASH\]).

Conditions

Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) with Compensated Cirrhosis

Talk to us

Study Overview

On this page

Study Details

Study overview

The study will assess the efficacy and safety of pegozafermin administered in participants with compensated cirrhosis due to MASH (biopsy-confirmed fibrosis stage F4 MASH \[previously known as nonalcoholic steatohepatitis, NASH\]).

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

A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants with Compensated Cirrhosis Due to MASH

Condition
Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) with Compensated Cirrhosis
Intervention / Treatment

-

Contacts and Locations

Homewood

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

Chandler

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

Flagstaff

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

Peoria

89bio Clinical Study Site, Peoria, Arizona, United States, 85381

Tucson

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

Tucson

89bio Clinical Study Site, Tucson, Arizona, United States, 85715

Tucson

89bio Clinical Study Site, Tucson, Arizona, United States, 85716

Little Rock

89bio Clinical Study Site, Little Rock, Arkansas, United States, 72205

North Little Rock

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

Camarillo

89bio Clinical Study Site, Camarillo, California, United States, 93012

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).
  • * At least 1 metabolic risk factor.
  • * Biopsy-confirmed fibrosis stage F4 MASH (per non-alcoholic steatohepatitis \[NASH\] Clinical Research Network (CRN) system) with compensated cirrhosis.
  • * Body mass index (BMI) at screening ≥25.0 (≥23.0 for Asian participants) and \<50.0 kilograms (kg)/meters squared (m\^2).
  • * Liver disorder other than MASH.
  • * History or evidence of hepatic decompensation.
  • * History or evidence of hepatocellular carcinoma.
  • * Have type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus.
  • * 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.,

Maya Margalit, MD, STUDY_DIRECTOR, 89bio, Inc.

Study Record Dates

2031-08