RECRUITING

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

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Conditions

Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) with Compensated CirrhosisLiver diseaseFatty LiverDigestive System DiseasesMetabolic diseasesMetabolic Dysfunction-Associated SteatohepatitisMASHNonalcoholic steatohepatitisNASHMetabolic dysfunction-associated steatotic liver diseaseMASLDNonalcoholic fatty liver diseaseNAFLDFibrosisCirrhosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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 \[previously known as nonalcoholic steatohepatitis, NASH\]).

Official Title

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)

Quick Facts

Study Start:2024-05-24
Study Completion:2031-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06419374

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.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Males or non-pregnant females aged between 18 and 75 years (inclusive) at time of signing the informed consent form (ICF).
  2. * At least 1 metabolic risk factor.
  3. * Biopsy-confirmed fibrosis stage F4 MASH (per non-alcoholic steatohepatitis \[NASH\] Clinical Research Network (CRN) system) with compensated cirrhosis.
  4. * Body mass index (BMI) at screening ≥25.0 (≥23.0 for Asian participants) and \<50.0 kilograms (kg)/meters squared (m\^2).
  1. * Liver disorder other than MASH.
  2. * History or evidence of hepatic decompensation.
  3. * History or evidence of hepatocellular carcinoma.
  4. * Have type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus.
  5. * ALT or aspartate aminotransferase (AST) ≥250 units per liter (U/L).
  6. * Participants taking vitamin E (\>400 international units \[IU\]/day) must be on stable dose for at least 6 months prior to screening.

Contacts and Locations

Study Contact

ENLIGHTEN clinical trial
CONTACT
1-415-432-9270
enlighten@89bio.com

Principal Investigator

Maya Margalit, MD
STUDY_DIRECTOR
89bio, Inc.

Study Locations (Sites)

89bio Clinical Study Site
Homewood, Alabama, 35209
United States
89bio Clinical Study Site
Chandler, Arizona, 85224
United States
89bio Clinical Study Site
Flagstaff, Arizona, 86001
United States
89bio Clinical Study Site
Peoria, Arizona, 85381
United States
89bio Clinical Study Site
Tucson, Arizona, 85712
United States
89bio Clinical Study Site
Tucson, Arizona, 85715
United States
89bio Clinical Study Site
Tucson, Arizona, 85716
United States
89bio Clinical Study Site
Little Rock, Arkansas, 72205
United States
89bio Clinical Study Site
North Little Rock, Arkansas, 72117
United States
89bio Clinical Study Site
Camarillo, California, 93012
United States
89bio Clinical Study Site
Canoga Park, California, 91304
United States
89bio Clinical Study Site
Fountain Valley, California, 92708
United States
89bio Clinical Study Site
Huntington Park, California, 90255
United States
89bio Clinical Study Site
Poway, California, 92064
United States
89bio Clinical Study Site
Rialto, California, 92377
United States
89bio Clinical Study Site
Santa Ana, California, 92704
United States
89bio Clinical Study Site
Hialeah Gardens, Florida, 33016
United States
89bio Clinical Study Site
Lady Lake, Florida, 32159
United States
89bio Clinical Study Site
Lehigh Acres, Florida, 33936
United States
89bio Clinical Study Site
Maitland, Florida, 32751
United States
89bio Clinical Study Site
Miami, Florida, 33176
United States
89bio Clinical Study Site
New Port Richey, Florida, 34653
United States
89bio Clinical Study Site
Ocala, Florida, 34471
United States
89bio Clinical Study Site
Ocoee, Florida, 34761
United States
89bio Clinical Study Site
Viera, Florida, 32940
United States
89bio Clinical Study Site
Winter Park, Florida, 32789
United States
89bio Clinical Study Site
Athens, Georgia, 30607
United States
89bio Clinical Study Site
New Albany, Indiana, 47150
United States
89bio Clinical Study Site
Topeka, Kansas, 66606
United States
89bio Clinical Study Site
Lafayette, Louisiana, 70503
United States
89bio Clinical Study Site
Baltimore, Maryland, 21202
United States
89bio Clinical Study Site
Glen Burnie, Maryland, 21061
United States
89bio Clinical Study Site
Greenbelt, Maryland, 20770
United States
89bio Clinical Study Site
Clinton Township, Michigan, 48038
United States
89bio Clinical Study Site
Ypsilanti, Michigan, 48197
United States
89bio Clinical Study Site
Flowood, Mississippi, 39232
United States
89bio Clinical Study Site
Las Vegas, Nevada, 89106
United States
89bio Clinical Study Site
Florham Park, New Jersey, 07932
United States
89bio Clinical Study Site
Albuquerque, New Mexico, 87109
United States
89bio Clinical Study Site
Greenville, North Carolina, 27834
United States
89bio Clinical Study Site
Dayton, Ohio, 45414
United States
89bio Clinical Study Site
Westlake, Ohio, 44145
United States
89bio Clinical Study Site
Charleston, South Carolina, 29425
United States
89bio Clinical Study Site
Cordova, Tennessee, 38018
United States
89bio Clinical Study Site
Hermitage, Tennessee, 37076
United States
89bio Clinical Study Site
Nashville, Tennessee, 37211
United States
89bio Clinical Study Site
Austin, Texas, 78745
United States
89bio Clinical Study Site
Austin, Texas, 78757-8059
United States
89bio Clinical Study Site
Austin, Texas, 78757-8066
United States
89bio Clinical Study Site
Brownsville, Texas, 78520
United States
89bio Clinical Study Site
Desoto, Texas, 75115
United States
89bio Clinical Study Site
Edinburg, Texas, 78539
United States
89bio Clinical Study Site
Farmers Branch, Texas, 75234
United States
89bio Clinical Study Site
Fort Worth, Texas, 76104
United States
89bio Clinical Study Site
Houston, Texas, 77099
United States
89bio Clinical Study Site
Lubbock, Texas, 79410
United States
89bio Clinical Study Site
Pearland, Texas, 77584
United States
89bio Clinical Study Site
San Antonio, Texas, 78209
United States
89bio Clinical Study Site
San Antonio, Texas, 78229
United States
89bio Clinical Study Site
Waco, Texas, 76710
United States
89bio Clinical Study Site
Waco, Texas, 76712
United States
89bio Clinical Study Site
Sandy, Utah, 84092
United States
89bio Clinical Study Site
Richmond, Virginia, 23229
United States

Collaborators and Investigators

Sponsor: 89bio, Inc.

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-24
Study Completion Date2031-08

Study Record Updates

Study Start Date2024-05-24
Study Completion Date2031-08

Terms related to this study

Keywords Provided by Researchers

  • Liver disease
  • Fatty Liver
  • Digestive System Diseases
  • Metabolic diseases
  • Metabolic Dysfunction-Associated Steatohepatitis
  • MASH
  • Nonalcoholic steatohepatitis
  • NASH
  • Metabolic dysfunction-associated steatotic liver disease
  • MASLD
  • Nonalcoholic fatty liver disease
  • NAFLD
  • Fibrosis
  • Cirrhosis

Additional Relevant MeSH Terms

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