Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With FibrosisPhase 3NCT06318169

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

A Phase 3 study testing Pegozafermin in people with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis, run by Hoffmann-La Roche at 370 sites in 27 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis
What is being tested?: Pegozafermin
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,350 participants
Where: 370 sitesin 27 countries
Study dates: 13 Mar 2024to Feb 2029
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Males or non-pregnant females aged between 18 and 80 years (inclusive) at time of signing the informed consent form (ICF)
Biopsy-confirmed MASH with fibrosis stage F2 or F3
Body mass index (BMI) at screening ≥25.0 kilograms (kg)/meters squared (m^2) (≥23 kg/m^2 for Asian participants).

Who cannot join

Chronic liver diseases other than MASH
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) or pioglitazone must be on stable dose for at least 6 months prior to Screening
Other inclusion and exclusion criteria may apply.

Trial locations and contacts

370 sites in 27 countries. Contact the study team or a site near you to ask about taking part.

Reference Study ID Number: BIO89-100-131 ENLIGHTEN clinical trial / No attachments to email below. contact

888-662-6728 (U.S. Only)

global-roche-genentech-trials@gene.com

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact

Country

City, postcode or hospital

Sites recruiting now only

370 sites in 27 countries

United States154 sites, 136 recruiting

89bio Clinical Study Site
Akron, Ohio, 44320
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89bio Clinical Study Site
Albany, New York, 12206
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89bio Clinical Study Site
Albuquerque, New Mexico, 87109
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89bio Clinical Study Site
Amarillo, Texas, 79106
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89bio Clinical Study Site
Athens, Georgia, 30607
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89bio Clinical Study Site
Austin, Texas, 78745
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89bio Clinical Study Site
Austin, Texas, 78757-8051
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89bio Clinical Study Site
Austin, Texas, 78757
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89bio Clinical Study Site
Baltimore, Maryland, 21202
89bio Clinical Study Site
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89bio Clinical Study Site
Bellaire, Texas, 77401
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89bio Clinical Study Site
Bellevue, Washington, 98004
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89bio Clinical Study Site
Birmingham, Alabama, 35209
89bio Clinical Study Site
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89bio Clinical Study Site
Brandon, Florida, 33511
89bio Clinical Study Site
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89bio Clinical Study Site
Brownsville, Texas, 78520
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89bio Clinical Study Site
Burlington, Massachusetts, 01805
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89bio Clinical Study Site
Canoga Park, California, 91604
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89bio Clinical Study Site
Carmel, New York, 10512
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89bio Clinical Study Site
Chandler, Arizona, 85224
89bio Clinical Study Site
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89bio Clinical Study Site
Charleston, South Carolina, 29425
89bio Clinical Study Site
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89bio Clinical Study Site
Charlotte, North Carolina, 28207
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89bio Clinical Study Site
Chattanooga, Tennessee, 37421
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89bio Clinical Study Site
Chesterfield, Michigan, 48047
89bio Clinical Study Site
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89bio Clinical Study Site
Chicago, Illinois, 60611
89bio Clinical Study Site
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89bio Clinical Study Site
Clermont, Florida, 34711
89bio Clinical Study Site
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89bio Clinical Study Site
Cleveland, Ohio, 44106
Withdrawn
89bio Clinical Study Site
Colorado Springs, Colorado, 80923
Withdrawn
89bio Clinical Study Site
Columbia, South Carolina, 29204
89bio Clinical Study Site
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89bio Clinical Study Site
Conway, Arkansas, 72032
Active, not recruiting
89bio Clinical Study Site
Cordova, Tennessee, 38018
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89bio Clinical Study Site
Coronado, California, 92118
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89bio Clinical Study Site
Corpus Christi, Texas, 78404
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89bio Clinical Study Site
Covington, Louisiana, 70433
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89bio Clinical Study Site
Dalton, Georgia, 30720
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89bio Clinical Study Site
Dayton, Ohio, 45145
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89bio Clinical Study Site
Dayton, Ohio, 45414
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89bio Clinical Study Site
Denton, Texas, 76201
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89bio Clinical Study Site
DeSoto, Texas, 75115
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89bio Clinical Study Site
Durham, North Carolina, 27710
89bio Clinical Study Site
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89bio Clinical Study Site
East Greenwich, Rhode Island, 02818
89bio Clinical Study Site
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89bio Clinical Study Site
Edinburg, Texas, 78539
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89bio Clinical Study Site
Escondido, California, 92025
89bio Clinical Study Site
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89bio Clinical Study Site
Farmers Branch, Texas, 75234
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89bio Clinical Study Site
Fayetteville, North Carolina, 28304
89bio Clinical Study Site
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89bio Clinical Study Site
Flagstaff, Arizona, 86001
Active, not recruiting
89bio Clinical Study Site
Florham Park, New Jersey, 07932
Withdrawn
89bio Clinical Study Site
Flowood, Mississippi, 39232
89bio Clinical Study Site
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89bio Clinical Study Site
Fort Myers, Florida, 33912
89bio Clinical Study Site
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89bio Clinical Study Site
Fort Sam Houston, Texas, 78234
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89bio Clinical Study Site
Fort Worth, Texas, 76104
89bio Clinical Study Site
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89bio Clinical Study Site
Fountain Valley, California, 92708
89bio Clinical Study Site
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89bio Clinical Study Site
Freehold, New Jersey, 07728
89bio Clinical Study Site
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89bio Clinical Study Site
Fresno, California, 93720
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89bio Clinical Study Site
Gardena, California, 90247
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89bio Clinical Study Site
Garland, Texas, 75044
89bio Clinical Study Site
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89bio Clinical Study Site
Georgetown, Texas, 78626
89bio Clinical Study Site
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89bio Clinical Study Site
Georgetown, Texas, 78628
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89bio Clinical Study Site
Glen Burnie, Maryland, 21061
89bio Clinical Study Site
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89bio Clinical Study Site
Glendale, Arizona, 85036
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89bio Clinical Study Site
Greenbelt, Maryland, 20770
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89bio Clinical Study Site
Hammond, Indiana, 46324
89bio Clinical Study Site
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89bio Clinical Study Site
Hermitage, Tennessee, 37076
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89bio Clinical Study Site
Hialeah Gardens, Florida, 33016
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89bio Clinical Study Site
Homestead, Florida, 33030
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89bio Clinical Study Site
Houma, Louisiana, 70360
89bio Clinical Study Site
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89bio Clinical Study Site
Houston, Texas, 77030
89bio Clinical Study Site
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89bio Clinical Study Site
Houston, Texas, 77090
89bio Clinical Study Site
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89bio Clinical Study Site
Houston, Texas, 77099
89bio Clinical Study Site
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89bio Clinical Study Site
Huntington Park, California, 90255
Withdrawn
89bio Clinical Study Site
Inglewood, California, 90301
Withdrawn
89bio Clinical Study Site
Iowa City, Iowa, 52242
89bio Clinical Study Site
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89bio Clinical Study Site
Jacksonville, Florida, 32256
89bio Clinical Study Site
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89bio Clinical Study Site
Jupiter, Florida, 33458
89bio Clinical Study Site
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89bio Clinical Study Site
Katy, Texas, 77494
89bio Clinical Study Site
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89bio Clinical Study Site
La Jolla, California, 92037
89bio Clinical Study Site
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89bio Clinical Study Site
Lady Lake, Florida, 32159-6831
89bio Clinical Study Site
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89bio Clinical Study Site
Lady Lake, Florida, 32159-8986
Withdrawn
89bio Clinical Study Site
Lake Charles, Louisiana, 70605
89bio Clinical Study Site
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89bio Clinical Study Site
Lakewood Rch, Florida, 34211
89bio Clinical Study Site
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89bio Clinical Study Site
Lancaster, California, 93534
89bio Clinical Study Site
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89bio Clinical Study Site
Las Vegas, Nevada, 89106
89bio Clinical Study Site
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89bio Clinical Study Site
Lehigh Acres, Florida, 33936
89bio Clinical Study Site
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89bio Clinical Study Site
Lewisville, Texas, 75067
89bio Clinical Study Site
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89bio Clinical Study Site
Liberty Township, Ohio, 45044
89bio Clinical Study Site
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89bio Clinical Study Site
Lima, Ohio, 45801
89bio Clinical Study Site
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89bio Clinical Study Site
Little Rock, Arkansas, 72211-3859
89bio Clinical Study Site
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89bio Clinical Study Site
Littleton, Colorado, 80120
89bio Clinical Study Site
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89bio Clinical Study Site
Long Beach, California, 90815
89bio Clinical Study Site
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89bio Clinical Study Site
Los Angeles, California, 90048
Withdrawn
89bio Clinical Study Site
Louisville, Kentucky, 40218
89bio Clinical Study Site
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89bio Clinical Study Site
Lubbock, Texas, 79424
89bio Clinical Study Site
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89bio Clinical Study Site
Maitland, Florida, 32751-7258
89bio Clinical Study Site
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89bio Clinical Study Site
Maitland, Florida, 32751-7497
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89bio Clinical Study Site
Maplewood, Minnesota, 55109
89bio Clinical Study Site
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89bio Clinical Study Site
Marietta, Georgia, 30060
89bio Clinical Study Site
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89bio Clinical Study Site
Marrero, Louisiana, 70072
89bio Clinical Study Site
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89bio Clinical Study Site
Miami, Florida, 33176
89bio Clinical Study Site
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89bio Clinical Study Site
Montclair, California, 91763
89bio Clinical Study Site
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89bio Clinical Study Site
Morehead City, North Carolina, 28557
Withdrawn
89bio Clinical Study Site
Nashville, Tennessee, 37211
89bio Clinical Study Site
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89bio Clinical Study Site
New Albany, Indiana, 47150
89bio Clinical Study Site
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89bio Clinical Study Site
New Orleans, Louisiana, 70115
Withdrawn
89bio Clinical Study Site
New Port Richey, Florida, 34653
89bio Clinical Study Site
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89bio Clinical Study Site
New York, New York, 10021
89bio Clinical Study Site
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89bio Clinical Study Site
New York, New York, 10033
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89bio Clinical Study Site
North Little Rock, Arkansas, 72117
89bio Clinical Study Site
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89bio Clinical Study Site
Ocala, Florida, 34471
89bio Clinical Study Site
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89bio Clinical Study Site
Ocoee, Florida, 34761
89bio Clinical Study Site
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89bio Clinical Study Site
Ogden, Utah, 84405
89bio Clinical Study Site
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89bio Clinical Study Site
Orange, California, 92868
89bio Clinical Study Site
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89bio Clinical Study Site
Panorama City, California, 91402
Withdrawn
89bio Clinical Study Site
Pasadena, California, 91105
89bio Clinical Study Site
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89bio Clinical Study Site
Poway, California, 92064
89bio Clinical Study Site
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89bio Clinical Study Site
Raleigh, North Carolina, 27612
89bio Clinical Study Site
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89bio Clinical Study Site
Rialto, California, 92377
89bio Clinical Study Site
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89bio Clinical Study Site
Richmond, Virginia, 23226-1925
89bio Clinical Study Site
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89bio Clinical Study Site
Richmond, Virginia, 23229
Active, not recruiting
89bio Clinical Study Site
Richmond, Virginia, 23236
89bio Clinical Study Site
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89bio Clinical Study Site
Richmond, Virginia, 23298
89bio Clinical Study Site
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89bio Clinical Study Site
Roanoke, Virginia, 24014
89bio Clinical Study Site
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89bio Clinical Study Site
Rochester, Minnesota, 55905
89bio Clinical Study Site
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89bio Clinical Study Site
San Antonio, Texas, 78209
89bio Clinical Study Site
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89bio Clinical Study Site
San Antonio, Texas, 78215
89bio Clinical Study Site
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89bio Clinical Study Site
San Antonio, Texas, 78222
89bio Clinical Study Site
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89bio Clinical Study Site
San Antonio, Texas, 78229-4801
89bio Clinical Study Site
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89bio Clinical Study Site
San Antonio, Texas, 78229
89bio Clinical Study Site
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89bio Clinical Study Site
Santa Ana, California, 92704-5763
Withdrawn
89bio Clinical Study Site
Sarasota, Florida, 34240
89bio Clinical Study Site
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89bio Clinical Study Site
Seattle, Washington, 98101
89bio Clinical Study Site
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89bio Clinical Study Site
Seattle, Washington, 98105
89bio Clinical Study Site
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89bio Clinical Study Site
South Bend, Indiana, 46635
89bio Clinical Study Site
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89bio Clinical Study Site
Southlake, Texas, 76092
89bio Clinical Study Site
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89bio Clinical Study Site
Springboro, Ohio, 45066
89bio Clinical Study Site
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89bio Clinical Study Site
St Louis, Missouri, 63123
89bio Clinical Study Site
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89bio Clinical Study Site
Stafford, Texas, 77477
89bio Clinical Study Site
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89bio Clinical Study Site
Stanford, California, 94305
89bio Clinical Study Site
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89bio Clinical Study Site
Sugar Land, Texas, 77479
89bio Clinical Study Site
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89bio Clinical Study Site
Sun City, Arizona, 85351
89bio Clinical Study Site
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89bio Clinical Study Site
Tacoma, Washington, 98405
89bio Clinical Study Site
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89bio Clinical Study Site
Tomball, Texas, 77584
89bio Clinical Study Site
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89bio Clinical Study Site
Topeka, Kansas, 66606
89bio Clinical Study Site
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89bio Clinical Study Site
Tucson, Arizona, 85712-4018
89bio Clinical Study Site
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89bio Clinical Study Site
Tucson, Arizona, 85716
89bio Clinical Study Site
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89bio Clinical Study Site
Tyler, Texas, 75701
89bio Clinical Study Site
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89bio Clinical Study Site
Victorville, California, 92395
89bio Clinical Study Site
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89bio Clinical Study Site
Waco, Texas, 76301
89bio Clinical Study Site
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89bio Clinical Study Site
Waco, Texas, 76712
Active, not recruiting
89bio Clinical Study Site
Warren Township, New Jersey, 07059
89bio Clinical Study Site
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89bio Clinical Study Site
West Monroe, Louisiana, 71291
89bio Clinical Study Site
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89bio Clinical Study Site
Westlake, Ohio, 44145
89bio Clinical Study Site
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89bio Clinical Study Site
Wilmington, North Carolina, 28401
89bio Clinical Study Site
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89bio Clinical Study Site
Winston-Salem, North Carolina, 27103
89bio Clinical Study Site
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89bio Clinical Study Site
Winter Park, Florida, 32789
89bio Clinical Study Site
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89bio Clinical Study Site
Wyoming, Michigan, 49519
89bio Clinical Study Site
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89bio Clinical Study Site
Ypsilanti, Michigan, 48197
89bio Clinical Study Site
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Other trials in United States

France20 sites, 20 recruiting

89bio Clinical Study Site
Amiens, 80080
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Angers, 49933
89bio Clinical Study Site
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89bio Clinical Study Site
Bordeaux, 33604
89bio Clinical Study Site
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89bio Clinical Study Site
Clichy, 92110
89bio Clinical Study Site
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89bio Clinical Study Site
Lille, 59000
89bio Clinical Study Site
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89bio Clinical Study Site
Limoges, 87042
89bio Clinical Study Site
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89bio Clinical Study Site
Lyon, 69004
89bio Clinical Study Site
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89bio Clinical Study Site
Montpellier, 34090
89bio Clinical Study Site
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89bio Clinical Study Site
Nantes, 44093
89bio Clinical Study Site
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89bio Clinical Study Site
Nice, 06200
89bio Clinical Study Site
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89bio Clinical Study Site
Paris, 75012
89bio Clinical Study Site
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89bio Clinical Study Site
Paris, 75013
89bio Clinical Study Site
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89bio Clinical Study Site
Paris, 75014
89bio Clinical Study Site
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89bio Clinical Study Site
Pierre-Bénite, 69310
89bio Clinical Study Site
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89bio Clinical Study Site
Strasbourg, 67000
89bio Clinical Study Site
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89bio Clinical Study Site
Toulouse, 31076
89bio Clinical Study Site
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89bio Clinical Study Site
Toulouse
89bio Clinical Study Site
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89bio Clinical Study Site
Vandœuvre-lès-Nancy, 54500
89bio Clinical Study Site
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89bio Clinical Study Site
Vénissieux, 69200
89bio Clinical Study Site
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89bio Clinical Study Site
Villejuif, 94800
89bio Clinical Study Site
Recruiting

Other trials in France

United Kingdom17 sites, 16 recruiting

89bio Clinical Study Site
Bristol, BS6 6LT
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Glasgow, G514TY
89bio Clinical Study Site
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89bio Clinical Study Site
High Wycombe, Buckinghamshire, HP11 2QW
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Hull, HU3 2JZ
Withdrawn
89bio Clinical Study Site
London, E13 8SL
89bio Clinical Study Site
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89bio Clinical Study Site
London, E1
89bio Clinical Study Site
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89bio Clinical Study Site
London, NW32QG
89bio Clinical Study Site
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89bio Clinical Study Site
London, SE5 9RS
89bio Clinical Study Site
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89bio Clinical Study Site
London, W2 1NY
89bio Clinical Study Site
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89bio Clinical Study Site
Oxford, OX3 9DU
89bio Clinical Study Site
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89bio Clinical Study Site
Portsmouth, PO6 3LY
89bio Clinical Study Site
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89bio Clinical Study Site
Preston, PR2 9QB
89bio Clinical Study Site
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89bio Clinical Study Site
Southampton, SO16 6YD
89bio Clinical Study Site
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89bio Clinical Study Site
Stockton, TS19
89bio Clinical Study Site
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89bio Clinical Study Site
Sunderland, SR4 7TP
89bio Clinical Study Site
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89bio Clinical Study Site
Swansea, SA6
89bio Clinical Study Site
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89bio Clinical Study Site
York, YO24 4LJ
89bio Clinical Study Site
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Other trials in United Kingdom

Japan16 sites, 16 recruiting

89bio Clinical Study Site
Ehime, 791-0295
89bio Clinical Study Site
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89bio Clinical Study Site
Ehime, 798-8510
89bio Clinical Study Site
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89bio Clinical Study Site
Fukuoka, 814-0180
89bio Clinical Study Site
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89bio Clinical Study Site
Gifu, 500-8323
89bio Clinical Study Site
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89bio Clinical Study Site
Hizume, Iwate, 028-3695
89bio Clinical Study Site
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89bio Clinical Study Site
Kawasaki, Kanagawa, 215-0026
89bio Clinical Study Site
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89bio Clinical Study Site
Kumamoto, 862-0971
89bio Clinical Study Site
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89bio Clinical Study Site
Maebashi, Gunma, 371-0821
89bio Clinical Study Site
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89bio Clinical Study Site
Nagano, 381-0006
89bio Clinical Study Site
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89bio Clinical Study Site
Okayama, 700-8558
89bio Clinical Study Site
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89bio Clinical Study Site
Osaka, 545-0051
89bio Clinical Study Site
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89bio Clinical Study Site
Osaka, 564-0013
89bio Clinical Study Site
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89bio Clinical Study Site
Saga, 849-0937
89bio Clinical Study Site
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89bio Clinical Study Site
Sapporo, Hokkaido, 065-0012
89bio Clinical Study Site
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89bio Clinical Study Site
Sapporo, 062-0921
89bio Clinical Study Site
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89bio Clinical Study Site
Yokohama, Kanagawa, 236-004
89bio Clinical Study Site
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Other trials in Japan

Italy13 sites, 13 recruiting

89bio Clinical Study Site
Bergamo, 24127
89bio Clinical Study Site
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89bio Clinical Study Site
Foggia, 71121
89bio Clinical Study Site
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89bio Clinical Study Site
Milan, 20089
89bio Clinical Study Site
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89bio Clinical Study Site
Milan, 20152
89bio Clinical Study Site
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89bio Clinical Study Site
Milan, 20162
89bio Clinical Study Site
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89bio Clinical Study Site
Modena, 41126
89bio Clinical Study Site
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89bio Clinical Study Site
Naples, 80131
89bio Clinical Study Site
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89bio Clinical Study Site
Novara, 28100
89bio Clinical Study Site
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89bio Clinical Study Site
Palermo, 90127
89bio Clinical Study Site
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89bio Clinical Study Site
Roma, 00128
89bio Clinical Study Site
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89bio Clinical Study Site
Rome, 00136
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Rome, 169
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Torino, 10126
89bio Clinical Study Site
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Other trials in Italy

Spain13 sites, 12 recruiting

89bio Clinical Study Site
Barcelona, 08003
89bio Clinical Study Site
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89bio Clinical Study Site
Barcelona, 08035
89bio Clinical Study Site
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89bio Clinical Study Site
Barcelona, 08036
89bio Clinical Study Site
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89bio Clinical Study Site
Barcelona, 08041
89bio Clinical Study Site
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89bio Clinical Study Site
Barcelona, 08916
89bio Clinical Study Site
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89bio Clinical Study Site
Córdoba, 14004
89bio Clinical Study Site
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89bio Clinical Study Site
Madrid, 28007
89bio Clinical Study Site
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89bio Clinical Study Site
Majadahonda, 28222
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Málaga, 29010
Withdrawn
89bio Clinical Study Site
Pontevedra, 36071
89bio Clinical Study Site
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89bio Clinical Study Site
Santander, 39008
89bio Clinical Study Site
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89bio Clinical Study Site
Santiago de Compostela, 15706
89bio Clinical Study Site
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89bio Clinical Study Site
Seville, 41013
89bio Clinical Study Site
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Other trials in Spain

Turkey (Türkiye)12 sites, 10 recruiting

89bio Clinical Study Site
Adana, 1370
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Ankara, 06230
89bio Clinical Study Site
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89bio Clinical Study Site
Ankara, 06800
89bio Clinical Study Site
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89bio Clinical Study Site
Bursa, 16110
89bio Clinical Study Site
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89bio Clinical Study Site
Center, 53020
89bio Clinical Study Site
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89bio Clinical Study Site
Fatih, 34093
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Gaziantep, 27410
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Istanbul, 34010
Withdrawn
89bio Clinical Study Site
Istanbul, 34899
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Izmir, 35360
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Sarıçam, 01790
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Ümraniye, 34764
Withdrawn

Other trials in Turkey (Türkiye)

Argentina11 sites, 10 recruiting

89bio Clinical Study Site
Buenos Aires, 1061
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Buenos Aires, 1125
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Buenos Aires, 1181
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Buenos Aires, C1012AAR
Withdrawn
89bio Clinical Study Site
Buenos Aires, C1061AAS
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Buenos Aires, C1425
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Caba, C1430CKE
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
CABA, CP.1056
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Capital Federal, C1280AEB
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Córdoba, X5000AAW
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Pilar, 1629
89bio Clinical Study Site
Recruiting

Other trials in Argentina

Australia10 sites, 10 recruiting

89bio Clinical Study Site
Adelaide, South Australia, 5000
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Bedford Park, South Australia, 5042
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Brisbane, Queensland, 4120
89bio Clinical Study Site
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89bio Clinical Study Site
Clayton, Victoria, 3168
89bio Clinical Study Site
Recruiting
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About this study

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

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.

Conditions: Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis
Being tested: Pegozafermin, Placebo
Keywords: 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
Medical subject headings: Non-alcoholic Fatty Liver Disease, Liver Diseases, Fatty Liver, Digestive System Diseases, Metabolic Diseases, Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PegozaferminBiological
Also called BIO89-100
Subcutaneous injection
PlaceboOther
Subcutaneous injection

Study groups in NCT06318169
Study group	Role	What they receive
Pegozafermin Regimen 1	Experimental	Not described Receives: Biological: Pegozafermin
Pegozafermin Regimen 2	Experimental	Not described Receives: Biological: Pegozafermin
Placebo	Placebo comparator	Matched Placebo will be administered in Regimens 1 and 2. Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With at Least an Improvement of Fibrosis ≥1 Stage Without Worsening of Steatohepatitis at Week 52
Worsening of steatohepatitis is defined as increase in non-alcoholic fatty liver disease (NAFLD) Activity Score (NAS) for ballooning, inflammation, or steatosis
Measured: Week 52
Number of Participants With Resolution of Steatohepatitis Without Worsening of Fibrosis at Week 52
Resolution of steatohepatitis is defined as total absence of ballooning (score=0) and absent or mild inflammation (score 0 to 1). Worsening of fibrosis is defined as progression of fibrosis by ≥1 stage.
Measured: Week 52
Time to First Occurrence of Disease Progression
Final analysis of the time to first occurrence of disease progression will be measured by a composite of protocol-specified clinical events
Measured: Up to 5 years

Secondary outcomes (2)

Percent Change from Baseline in Alanine Aminotransferase at Week 52
Measured: Baseline, Week 52
Absolute Change From Baseline in Enhanced Liver Fibrosis (ELF) Score at Week 52
Measured: Baseline, Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Mar 2024Feb 2029

First posted19 Mar 2024
Study start13 Mar 2024
Primary completionFeb 2029 (estimated)
Study completionFeb 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With FibrosisStudies of the same condition, open and under way.
More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,350 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06318169
Sponsor's protocol ID: BIO89-100-131
Other IDs: GC46896
Status last verified: Oct 2026
First submitted: 13 Mar 2024
Last updated: 23 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Interested in taking part?

Reference Study ID Number: BIO89-100-131 ENLIGHTEN clinical trial / No attachments to email below.

888-662-6728 (U.S. Only)

global-roche-genentech-trials@gene.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 2
Study to Evaluate ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Metabolic Dysfunction-Associated Steatohepatitis (MASH)
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH
Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis
Active, not recruitingPhase 4
Effect of a GnRH Analog on Hepatic Steatosis
Metabolic Dysfunction-Associated Steatotic Liver Disease, Nonalcoholic Fatty Liver
Active, not recruitingPhase 2
Phase II Study Evaluating the Efficacy and Safety of DR10624 Injection in MASLD and MetALD Subjects
MASLD

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

Study at a glance

From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
ClinicalTrials.gov ID: NCT06318169
Acronym / sponsor ID: BIO89-100-131
Conditions: Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis
Keywords: Liver Diseases, Fatty Liver, Digestive System Diseases, Metabolic diseases, Metabolic Dysfunction-Associated Steatohepatitis, MASH, Steatohepatitis, Metabolic dysfunction-associated steatotic liver disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 1,350 participants (estimated)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: 13 Mar 2024 (actual)
Primary completion: Feb 2029 (estimated)
Study completion: Feb 2029 (estimated)
First posted: 19 Mar 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Pegozafermin Regimen 1	Experimental	Biological: Pegozafermin
Pegozafermin Regimen 2	Experimental	Biological: Pegozafermin
Placebo	Placebo comparator	Other: PlaceboMatched Placebo will be administered in Regimens 1 and 2.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Males or non-pregnant females aged between 18 and 80 years (inclusive) at time of signing the informed consent form (ICF)
Biopsy-confirmed MASH with fibrosis stage F2 or F3
Body mass index (BMI) at screening ≥25.0 kilograms (kg)/meters squared (m^2) (≥23 kg/m^2 for Asian participants).

Key exclusion criteria (6 listed)

Chronic liver diseases other than MASH
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) or pioglitazone must be on stable dose for at least 6 months prior to Screening

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PegozaferminAlso: BIO89-100Subcutaneous injection	Biological	Pegozafermin Regimen 1, Pegozafermin Regimen 2
PlaceboSubcutaneous injection	Other	Placebo

Primary outcome

Number of Participants With at Least an Improvement of Fibrosis ≥1 Stage Without Worsening of Steatohepatitis at Week 52
Time frame: Week 52
Worsening of steatohepatitis is defined as increase in non-alcoholic fatty liver disease (NAFLD) Activity Score (NAS) for ballooning, inflammation, or steatosis
Number of Participants With Resolution of Steatohepatitis Without Worsening of Fibrosis at Week 52
Time frame: Week 52
Resolution of steatohepatitis is defined as total absence of ballooning (score=0) and absent or mild inflammation (score 0 to 1). Worsening of fibrosis is defined as progression of fibrosis by ≥1 stage.
Time to First Occurrence of Disease Progression
Time frame: Up to 5 years
Final analysis of the time to first occurrence of disease progression will be measured by a composite of protocol-specified clinical events

2 secondary outcomes

Percent Change from Baseline in Alanine Aminotransferase at Week 52
Time frame: Baseline, Week 52
Absolute Change From Baseline in Enhanced Liver Fibrosis (ELF) Score at Week 52
Time frame: Baseline, Week 52

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.

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

RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 2
Study to Evaluate ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)
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A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH
Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis
Active, not recruitingPhase 4
Effect of a GnRH Analog on Hepatic Steatosis
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Active, not recruitingPhase 2
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MASLD

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Reference Study ID Number: BIO89-100-131 ENLIGHTEN clinical trial / No attachments to email below. contact

888-662-6728 (U.S. Only)

global-roche-genentech-trials@gene.com

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact

Clinical Trials study director

89bio, Inc.

370 sites in 27 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 370 sites in United States, France, United Kingdom, Japan, Italy and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Reference Study ID Number: BIO89-100-131 ENLIGHTEN clinical trial / No attachments to email below. (888-662-6728 (U.S. Only), global-roche-genentech-trials@gene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With at Least an Improvement of Fibrosis ≥1 Stage Without Worsening of Steatohepatitis at Week 52 (time frame: Week 52). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06318169.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.