RECRUITING

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

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Conditions

Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With FibrosisLiver DiseasesFatty LiverDigestive System DiseasesMetabolic diseasesMetabolic Dysfunction-Associated SteatohepatitisMASHSteatohepatitisMetabolic dysfunction-associated steatotic liver diseaseMASLDNonalcoholic fatty liver diseaseNAFLDFibrosis

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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 2 dose regimens of pegozafermin compared to placebo for the treatment of liver fibrosis stage F2 or F3 in adult participants with MASH.

Official Title

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

Quick Facts

Study Start:2024-03-13
Study Completion:2029-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06318169

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 80 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 80 years (inclusive) at time of signing the informed consent form (ICF)
  2. * Biopsy-confirmed MASH with fibrosis stage F2 or F3
  3. * Body mass index (BMI) at screening ≥25.0 kilograms (kg)/meters squared (m\^2) (≥23 kg/m\^2 for Asian participants).
  1. * Chronic liver diseases other than MASH
  2. * Evidence of cirrhosis on screening liver biopsy
  3. * Have type 1 diabetes or poorly controlled type 2 diabetes
  4. * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥250 units per liter (U/L)
  5. * Participants taking vitamin E (\>400 international units \[IU\]/day) or pioglitazone 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

Millie Gottwald, PharmD
STUDY_DIRECTOR
89bio, Inc.

Study Locations (Sites)

89bio Clinical Study Site
Birmingham, 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
Glendale, Arizona, 85036
United States
89bio Clinical Study Site
Tucson, Arizona, 85712
United States
89bio Clinical Study Site
Conway, Arkansas, 72032
United States
89bio Clinical Study Site
Little Rock, Arkansas, 72211-3859
United States
89bio Clinical Study Site
North Little Rock, Arkansas, 72117
United States
89bio Clinical Study Site
Canoga Park, California, 91604
United States
89bio Clinical Study Site
Coronado, California, 92118
United States
89bio Clinical Study Site
Fountain Valley, California, 92708
United States
89bio Clinical Study Site
Fresno, California, 93720
United States
89bio Clinical Study Site
Gardena, California, 90247
United States
89bio Clinical Study Site
Huntington Park, California, 90255
United States
89bio Clinical Study Site
Inglewood, California, 90301
United States
89bio Clinical Study Site
Lancaster, California, 93534
United States
89bio Clinical Study Site
Long Beach, California, 90815
United States
89bio Clinical Study Site
Los Angeles, California, 90048
United States
89bio Clinical Study Site
Montclair, California, 91763
United States
89bio Clinical Study Site
Orange, California, 92868
United States
89bio Clinical Study Site
Panorama City, California, 91402
United States
89bio Clinical Study Site
Pasadena, California, 91105
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, 92704-5763
United States
89bio Clinical Study Site
Stanford, California, 94305
United States
89bio Clinical Study Site
Victorville, California, 92395
United States
89bio Clinical Study Site
Colorado Springs, Colorado, 80923
United States
89bio Clinical Study Site
Littleton, Colorado, 80120
United States
89bio Clinical Study Site
Brandon, Florida, 33511
United States
89bio Clinical Study Site
Clermont, Florida, 34711
United States
89bio Clinical Study Site
Fort Myers, Florida, 33912
United States
89bio Clinical Study Site
Hialeah Gardens, Florida, 33016
United States
89bio Clinical Study Site
Jacksonville, Florida, 32256
United States
89bio Clinical Study Site
Jupiter, Florida, 33458
United States
89bio Clinical Study Site
Lady Lake, Florida, 32159-6831
United States
89bio Clinical Study Site
Lady Lake, Florida, 32159-8986
United States
89bio Clinical Study Site
Lakewood Rch, Florida, 34211
United States
89bio Clinical Study Site
Maitland, Florida, 32751-7258
United States
89bio Clinical Study Site
Maitland, Florida, 32751-7497
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
Sarasota, Florida, 34240
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
Dalton, Georgia, 30720
United States
89bio Clinical Study Site
Hammond, Indiana, 46324
United States
89bio Clinical Study Site
New Albany, Indiana, 47150
United States
89bio Clinical Study Site
South Bend, Indiana, 46635
United States
89bio Clinical Study Site
Iowa City, Iowa, 52242
United States
89bio Clinical Study Site
Topeka, Kansas, 66606
United States
89bio Clinical Study Site
Covington, Louisiana, 70433
United States
89bio Clinical Study Site
Houma, Louisiana, 70360
United States
89bio Clinical Study Site
Marrero, Louisiana, 70072
United States
89bio Clinical Study Site
New Orleans, Louisiana, 70115
United States
89bio Clinical Study Site
West Monroe, Louisiana, 71291
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
Chesterfield, Michigan, 48047
United States
89bio Clinical Study Site
Wyoming, Michigan, 49519
United States
89bio Clinical Study Site
Ypsilanti, Michigan, 48197
United States
89bio Clinical Study Site
Rochester, Minnesota, 55905
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
Freehold, New Jersey, 07728
United States
89bio Clinical Study Site
Warren Township, New Jersey, 07059
United States
89bio Clinical Study Site
Albuquerque, New Mexico, 87109
United States
89bio Clinical Study Site
New York, New York, 10033
United States
89bio Clinical Study Site
Charlotte, North Carolina, 28207
United States
89bio Clinical Study Site
Durham, North Carolina, 27710
United States
89bio Clinical Study Site
Fayetteville, North Carolina, 28304
United States
89bio Clinical Study Site
Raleigh, North Carolina, 27612
United States
89bio Clinical Study Site
Winston-Salem, North Carolina, 27103
United States
89bio Clinical Study Site
Akron, Ohio, 44320
United States
89bio Clinical Study Site
Cleveland, Ohio, 44106
United States
89bio Clinical Study Site
Dayton, Ohio, 45414
United States
89bio Clinical Study Site
Liberty Township, Ohio, 45044
United States
89bio Clinical Study Site
Springboro, Ohio, 45066
United States
89bio Clinical Study Site
Westlake, Ohio, 44145
United States
89bio Clinical Study Site
East Greenwich, Rhode Island, 02818
United States
89bio Clinical Study Site
Charleston, South Carolina, 29425
United States
89bio Clinical Study Site
Columbia, South Carolina, 29204
United States
89bio Clinical Study Site
Chattanooga, Tennessee, 37421
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
Amarillo, Texas, 79106
United States
89bio Clinical Study Site
Austin, Texas, 78745
United States
89bio Clinical Study Site
Austin, Texas, 78757-8051
United States
89bio Clinical Study Site
Austin, Texas, 78757
United States
89bio Clinical Study Site
Bellaire, Texas, 77401
United States
89bio Clinical Study Site
Brownsville, Texas, 78520
United States
89bio Clinical Study Site
Corpus Christi, Texas, 78404
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 Sam Houston, Texas, 78234
United States
89bio Clinical Study Site
Fort Worth, Texas, 76104
United States
89bio Clinical Study Site
Garland, Texas, 75044
United States
89bio Clinical Study Site
Georgetown, Texas, 78626
United States
89bio Clinical Study Site
Georgetown, Texas, 78628
United States
89bio Clinical Study Site
Houston, Texas, 77099
United States
89bio Clinical Study Site
Katy, Texas, 77494
United States
89bio Clinical Study Site
San Antonio, Texas, 78209
United States
89bio Clinical Study Site
San Antonio, Texas, 78215
United States
89bio Clinical Study Site
San Antonio, Texas, 78222
United States
89bio Clinical Study Site
San Antonio, Texas, 78229-4801
United States
89bio Clinical Study Site
San Antonio, Texas, 78229
United States
89bio Clinical Study Site
Stafford, Texas, 77477
United States
89bio Clinical Study Site
Tomball, Texas, 77584
United States
89bio Clinical Study Site
Waco, Texas, 76301
United States
89bio Clinical Study Site
Waco, Texas, 76710
United States
89bio Clinical Study Site
Ogden, Utah, 84405
United States
89bio Clinical Study Site
Richmond, Virginia, 23226-1925
United States
89bio Clinical Study Site
Richmond, Virginia, 23229
United States
89bio Clinical Study Site
Richmond, Virginia, 23236
United States
89bio Clinical Study Site
Richmond, Virginia, 23298
United States
89bio Clinical Study Site
Roanoke, Virginia, 24014
United States
89bio Clinical Study Site
Seattle, Washington, 98101
United States
89bio Clinical Study Site
Seattle, Washington, 98105
United States

Collaborators and Investigators

Sponsor: 89bio, Inc.

  • Millie Gottwald, PharmD, 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 Date2024-03-13
Study Completion Date2029-02

Study Record Updates

Study Start Date2024-03-13
Study Completion Date2029-02

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis