Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated CirrhosisPhase 3NCT06419374

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

A Phase 3 study testing Pegozafermin in people with Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis, run by Hoffmann-La Roche at 330 sites in 25 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 pegozafermin administered in participants with biopsy-confirmed and clinically confirmed compensated cirrhosis due to MASH . Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis
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: 1,800 participants
Where: 330 sitesin 25 countries
Study dates: 24 May 2024to 31 Aug 2031
Phase: Phase 3

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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Males or non-pregnant females aged between 18 and 75 years (inclusive) at time of signing the informed consent form (ICF).
Participants must have type 2 diabetes mellitus diagnosed at least 3 months before screening or at least 2 metabolic risk factors.
Evidence of both cirrhosis and MASH etiology, either through a historical biopsy or a biopsy at Screening.
Clinical diagnosis of cirrhosis based on the NIT algorithm.

Who cannot join

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.
Other protocol-defined inclusion and exclusion criteria may apply.

Trial locations and contacts

330 sites in 25 countries. Contact the study team or a site near you to ask about taking part.

Reference Study ID Number: BIO89-100-132 / GC46898 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

330 sites in 25 countries

United States150 sites, 131 recruiting

89bio Clinical Study Site
Akron, Ohio, 44320
89bio Clinical Study Site
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89bio Clinical Study Site
Albany, New York, 12206
89bio Clinical Study Site
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89bio Clinical Study Site
Albuquerque, New Mexico, 87109
89bio Clinical Study Site
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89bio Clinical Study Site
Amarillo, Texas, 79106
89bio Clinical Study Site
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89bio Clinical Study Site
Ann Arbor, Michigan, 48109
89bio Clinical Study Site
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89bio Clinical Study Site
Asheville, North Carolina, 28801
89bio Clinical Study Site
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89bio Clinical Study Site
Athens, Georgia, 30607
89bio Clinical Study Site
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89bio Clinical Study Site
Atlanta, Georgia, 30309
89bio Clinical Study Site
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89bio Clinical Study Site
Austin, Texas, 78745
89bio Clinical Study Site
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89bio Clinical Study Site
Austin, Texas, 78757-8059
89bio Clinical Study Site
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89bio Clinical Study Site
Austin, Texas, 78757-8066
89bio Clinical Study Site
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89bio Clinical Study Site
Baltimore, Maryland, 21202
89bio Clinical Study Site
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89bio Clinical Study Site
Bellevue, Washington, 98004
89bio Clinical Study Site
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89bio Clinical Study Site
Birmingham, Alabama, 35205
89bio Clinical Study Site
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89bio Clinical Study Site
Brownsville, Texas, 78520
89bio Clinical Study Site
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89bio Clinical Study Site
Burlington, Massachusetts, 01805
89bio Clinical Study Site
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89bio Clinical Study Site
Camarillo, California, 93012
89bio Clinical Study Site
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89bio Clinical Study Site
Canoga Park, California, 91304
89bio Clinical Study Site
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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
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
Cincinnati, Ohio, 45267
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
89bio Clinical Study Site
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89bio Clinical Study Site
Clinton Township, Michigan, 48038
89bio Clinical Study Site
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89bio Clinical Study Site
Columbia, South Carolina, 29204
89bio Clinical Study Site
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89bio Clinical Study Site
Columbus, Ohio, 43210
89bio Clinical Study Site
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89bio Clinical Study Site
Cordova, Tennessee, 38018
89bio Clinical Study Site
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89bio Clinical Study Site
Coronado, California, 92118
89bio Clinical Study Site
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89bio Clinical Study Site
Dayton, Ohio, 45145
89bio Clinical Study Site
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89bio Clinical Study Site
Dayton, Ohio, 45414
89bio Clinical Study Site
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89bio Clinical Study Site
DeSoto, Texas, 75115
89bio Clinical Study Site
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89bio Clinical Study Site
Detroit, Michigan, 48202
89bio Clinical Study Site
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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
Terminated
89bio Clinical Study Site
Farmers Branch, Texas, 75234
89bio Clinical Study Site
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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
Withdrawn
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 Worth, Texas, 76104
Withdrawn
89bio Clinical Study Site
Fountain Valley, California, 92708
89bio Clinical Study Site
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89bio Clinical Study Site
Framingham, Massachusetts, 01702
89bio Clinical Study Site
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89bio Clinical Study Site
Fresno, California, 93720
89bio Clinical Study Site
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89bio Clinical Study Site
Gainesville, Florida, 32610
89bio Clinical Study Site
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89bio Clinical Study Site
Georgetown, Texas, 78628
89bio Clinical Study Site
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89bio Clinical Study Site
Glen Burnie, Maryland, 21061
89bio Clinical Study Site
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89bio Clinical Study Site
Glenview, Illinois, 60026
89bio Clinical Study Site
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89bio Clinical Study Site
Greenbelt, Maryland, 20770
89bio Clinical Study Site
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89bio Clinical Study Site
Greenville, North Carolina, 27834
Withdrawn
89bio Clinical Study Site
Hammond, Indiana, 46324
89bio Clinical Study Site
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89bio Clinical Study Site
Harlingen, Texas, 78550
Withdrawn
89bio Clinical Study Site
Hermitage, Tennessee, 37076
89bio Clinical Study Site
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89bio Clinical Study Site
Hialeah Gardens, Florida, 33016
89bio Clinical Study Site
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89bio Clinical Study Site
Homestead, Florida, 33030
89bio Clinical Study Site
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89bio Clinical Study Site
Homewood, Alabama, 35209
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, 77074
Withdrawn
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
Iowa City, Iowa, 52242
89bio Clinical Study Site
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89bio Clinical Study Site
Jacksonville, Florida, 32224
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
Kansas City, Kansas, 66160
89bio Clinical Study Site
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89bio Clinical Study Site
La Jolla, California, 92037-0887
89bio Clinical Study Site
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89bio Clinical Study Site
Lady Lake, Florida, 32159
Withdrawn
89bio Clinical Study Site
Lafayette, Louisiana, 70503
89bio Clinical Study Site
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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
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
Little Rock, Arkansas, 72205
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
Los Angeles, California, 90033
89bio Clinical Study Site
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89bio Clinical Study Site
Los Angeles, California, 90048
89bio Clinical Study Site
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89bio Clinical Study Site
Louisville, Kentucky, 40218
89bio Clinical Study Site
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89bio Clinical Study Site
Lubbock, Texas, 79410
Withdrawn
89bio Clinical Study Site
Lubbock, Texas, 79424
89bio Clinical Study Site
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89bio Clinical Study Site
Maitland, Florida, 32751
Withdrawn
89bio Clinical Study Site
Mansfield, Texas, 76063
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
Miami, Florida, 33144
89bio Clinical Study Site
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89bio Clinical Study Site
Miami, Florida, 33176-1530
89bio Clinical Study Site
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89bio Clinical Study Site
Miami, Florida, 33176-7947
Withdrawn
89bio Clinical Study Site
Miami, Florida, 33176
89bio Clinical Study Site
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89bio Clinical Study Site
Minneapolis, Minnesota, 55413
89bio Clinical Study Site
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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 Port Richey, Florida, 34653
89bio Clinical Study Site
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89bio Clinical Study Site
New York, New York, 10016
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
Withdrawn
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
Orlando, Florida, 32825
Terminated
89bio Clinical Study Site
Pasadena, California, 91105
89bio Clinical Study Site
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89bio Clinical Study Site
Pearland, Texas, 77584
Withdrawn
89bio Clinical Study Site
Peoria, Arizona, 85381
89bio Clinical Study Site
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89bio Clinical Study Site
Philadelphia, Pennsylvania, 19148
89bio Clinical Study Site
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89bio Clinical Study Site
Phoenix, Arizona, 85054
89bio Clinical Study Site
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89bio Clinical Study Site
Pittsburgh, Pennsylvania, 15213
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
Rapid City, South Dakota, 57701
89bio Clinical Study Site
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89bio Clinical Study Site
Redwood City, California, 94063
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
89bio Clinical Study Site
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89bio Clinical Study Site
Richmond, Virginia, 23229
Withdrawn
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
Rochester, Minnesota, 55905
89bio Clinical Study Site
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89bio Clinical Study Site
Sacramento, California, 95817
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, 78229-4801
89bio Clinical Study Site
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89bio Clinical Study Site
San Antonio, Texas, 78229-5069
89bio Clinical Study Site
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89bio Clinical Study Site
San Marcos, Texas, 78666
89bio Clinical Study Site
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89bio Clinical Study Site
Sandy City, Utah, 84092
89bio Clinical Study Site
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89bio Clinical Study Site
Santa Ana, California, 92704
Withdrawn
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
Somers Point, New Jersey, 08244
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
St Louis, Missouri, 63110
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
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
Topeka, Kansas, 66606
89bio Clinical Study Site
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89bio Clinical Study Site
Tucson, Arizona, 85712
89bio Clinical Study Site
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89bio Clinical Study Site
Tucson, Arizona, 85715
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
Tupelo, Mississippi, 38801
Withdrawn
89bio Clinical Study Site
Tyler, Texas, 75701
89bio Clinical Study Site
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89bio Clinical Study Site
University Park, Florida, 34201
89bio Clinical Study Site
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89bio Clinical Study Site
Viera, Florida, 32940
89bio Clinical Study Site
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89bio Clinical Study Site
Waco, Texas, 76710
89bio Clinical Study Site
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89bio Clinical Study Site
Waco, Texas, 76712
Terminated
89bio Clinical Study Site
West Jordan, Utah, 84088
89bio Clinical Study Site
Recruiting
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
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

France17 sites, 16 recruiting

89bio Clinical Study Site
Amiens, 80054
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Clichy, 92110
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Dijon, 21000
Withdrawn
89bio Clinical Study Site
Limoges, 87000
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Lyon, 69004
89bio Clinical Study Site
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89bio Clinical Study Site
Montpellier, 34295
89bio Clinical Study Site
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89bio Clinical Study Site
Nice, 06202
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
Pessac, 33604
89bio Clinical Study Site
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89bio Clinical Study Site
Strasbourg, 67091
89bio Clinical Study Site
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89bio Clinical Study Site
Toulouse, 31076 Cedex 3
89bio Clinical Study Site
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89bio Clinical Study Site
Toulouse, 31400
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, 69694
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Villejuif, 94800
89bio Clinical Study Site
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Other trials in France

Spain12 sites, 11 recruiting

89bio Clinical Study Site
Almería, 04009
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Badalona, 08916
89bio Clinical Study Site
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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, 08041
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
Recruiting
89bio Clinical Study Site
Málaga, 29010
Withdrawn
89bio Clinical Study Site
Pontevedra, 36071
89bio Clinical Study Site
Recruiting
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
Recruiting
89bio Clinical Study Site
Zaragoza, 50009
89bio Clinical Study Site
Recruiting

Other trials in Spain

United Kingdom12 sites, 12 recruiting

89bio Clinical Study Site
Aberdeen, AB25 2ZN
89bio Clinical Study Site
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89bio Clinical Study Site
Bristol, BS10 5NB
89bio Clinical Study Site
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89bio Clinical Study Site
Leeds, LS9 7TF
89bio Clinical Study Site
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89bio Clinical Study Site
London, E1 1BB
89bio Clinical Study Site
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89bio Clinical Study Site
London, NW3 2QG
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
Recruiting
89bio Clinical Study Site
Plymouth, PL6 8DH
89bio Clinical Study Site
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89bio Clinical Study Site
Port Talbot, SA12 7BR
89bio Clinical Study Site
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89bio Clinical Study Site
Portsmouth, P06 3LY
89bio Clinical Study Site
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89bio Clinical Study Site
Southampton, SO16 6YD
89bio Clinical Study Site
Recruiting

Other trials in United Kingdom

Argentina11 sites, 11 recruiting

89bio Clinical Study Site
Buenos Aires, C1012AAR
89bio Clinical Study Site
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89bio Clinical Study Site
Buenos Aires, C1061AAS
89bio Clinical Study Site
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89bio Clinical Study Site
Buenos Aires, C1125ABE
89bio Clinical Study Site
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89bio Clinical Study Site
Buenos Aires, C1199ABB
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Buenos Aires, C1425BGH
89bio Clinical Study Site
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89bio Clinical Study Site
Buenos Aires, C1425
89bio Clinical Study Site
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89bio Clinical Study Site
Buenos Aires, CP 1061
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
CABA, C1430CKE
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, B1629AHJ
89bio Clinical Study Site
Recruiting

Other trials in Argentina

Brazil11 sites, 11 recruiting

89bio Clinical Study Site
Barretos, 14784-400
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Belo Horizonte, 30220-140
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Botucatu, 18618-687
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Brasília, 71625009
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Goiânia, 74605-050
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Porto Alegre, 90035-903
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Rio de Janeiro, 21941-617
89bio Clinical Study Site
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89bio Clinical Study Site
Salvador, 41820-460
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
São José do Rio Preto, 15090-000
89bio Clinical Study Site
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89bio Clinical Study Site
São Paulo, 04038-002
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Vitória, 29055-450
89bio Clinical Study Site
Recruiting

Other trials in Brazil

Turkey (Türkiye)11 sites, 10 recruiting

89bio Clinical Study Site
Ankara, 06100
Withdrawn
89bio Clinical Study Site
Ankara, 6800
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Bornova, İzmir, 35040
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Fatih, 34093
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Istanbul, 34010
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Istanbul, 34722
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Izmir, 35360
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Merkez, Rize Province, 53020
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Sarıçam, 01790
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Ümraniye, 34764
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Yüreğir, 1370
89bio Clinical Study Site
Recruiting

Other trials in Turkey (Türkiye)

Italy10 sites, 10 recruiting

89bio Clinical Study Site
Bergamo, 24127
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Foggia, 71121
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Milan, 20122
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Milan, 20162
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Novara, 28100
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Palermo, 90127
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Roma, 00128
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Rome, 00168
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Rozzano, 20089
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Torino, 10124
89bio Clinical Study Site
Recruiting

Other trials in Italy

South Korea10 sites, 10 recruiting

89bio Clinical Study Site
Bucheon-si, 14584
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Busan, 49241
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Daegu, 42415
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Daegu, 700-712
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Incheon, 22332
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Seoul, 03080
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Seoul, 06591
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Seoul, 07061
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Seoul, 07895
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Seoul, 130-872
89bio Clinical Study Site
Recruiting

Other trials in South Korea

Israel9 sites, 9 recruiting

89bio Clinical Study Site
Afula, 1834111
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Beersheba, 8410101
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Haifa, 3109601
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Haifa, 3436212
Enrolling by invitation
89bio Clinical Study Site
Jerusalem, 9112001
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Nahariya, 2210001
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Petah Tikva, 49100
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Tel Aviv, 69710
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Tel Litwinsky, 5265601
89bio Clinical Study Site
Recruiting

Other trials in Israel

Poland9 sites, 5 recruiting

89bio Clinical Study Site
Katowice, 40-752
Withdrawn
89bio Clinical Study Site
Krakow, 31-501
Withdrawn
89bio Clinical Study Site
Lodz, 90-302
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Lodz, 91-363
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Mysłowice, 41-400
Withdrawn
89bio Clinical Study Site
Warsaw, 00-215
Withdrawn
89bio Clinical Study Site
Warsaw, 02-172
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Warsaw, 04-501
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Wroclaw, 53-673
89bio Clinical Study Site
Recruiting

Other trials in Poland

Australia8 sites, 8 recruiting

89bio Clinical Study Site
Adelaide, SA 5000
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Fitzroy, 03065
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Greenslopes, 04120
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Heidelberg, 3084
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Herston, Qld 4029
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Murdoch, 06150
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Perth, 06000
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
South Brisbane, 04101
89bio Clinical Study Site
Recruiting

Other trials in Australia

Canada8 sites, 7 recruiting

89bio Clinical Study Site
Calgary, Alberta, T2N 4Z6
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
London, Ontario, N6A5A5
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Ottawa, Ontario, K1H 8L6
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Toronto, Ontario, M6H3M1
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Vancouver, British Columbia, V5Z 1M9
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Vancouver, British Columbia, V6Z2K5
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Vaughan, L4L 4Y7
Withdrawn
89bio Clinical Study Site
Winnipeg, Manitoba, R3E 3P4
89bio Clinical Study Site
Recruiting

Other trials in Canada

Mexico8 sites, 8 recruiting

89bio Clinical Study Site
Chihuahua City, 31217
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Cuautitlán Izcalli, CP 54769
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Cuernavaca, 62250
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Jalisco, 44130
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Mérida, 97070
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Mexico City, 03330
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Mexico City, 06700
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Monterrey, 64310
89bio Clinical Study Site
Recruiting

Other trials in Mexico

Belgium7 sites, 6 recruiting

89bio Clinical Study Site
Brussels, 01070
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Brussels, 01090
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Brussels, 1200
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Edegem, 02650
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Genk, 03600
Withdrawn
89bio Clinical Study Site
Ghent, 09000
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Roeselare, 08800
89bio Clinical Study Site
Recruiting

Other trials in Belgium

Germany6 sites, 6 recruiting

89bio Clinical Study Site
Chemnitz, 9116
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Frankfurt, 60590
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Freiburg im Breisgau, 79110
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Hanover, 30625
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Homburg, 66421
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Münster, 48149
89bio Clinical Study Site
Recruiting

Other trials in Germany

India5 sites, 5 recruiting

89bio Clinical Study Site
Gujrāt, 360001
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Prayagraj, 211002
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Rajpur Sonarpur, 700150
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Sūrat, 395009
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Wardha, 442004
89bio Clinical Study Site
Recruiting

Other trials in India

Bulgaria4 sites, 2 recruiting

89bio Clinical Study Site
Gorna Oryahovitsa, 05100
Withdrawn
89bio Clinical Study Site
Sofia, 01202
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Sofia, 01407
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Stara Zagora, 06003
Withdrawn

Other trials in Bulgaria

Netherlands4 sites, 3 recruiting

89bio Clinical Study Site
Amsterdam, 1081 HV
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Rotterdam, 3015GD
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Tilburg, 5022 GC
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Utrecht, 3584 CX
Withdrawn

Other trials in Netherlands

Singapore4 sites, 4 recruiting

89bio Clinical Study Site
Singapore, 119074
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Singapore, 169608
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Singapore, 308433
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Singapore, 529889
89bio Clinical Study Site
Recruiting

Other trials in Singapore

Georgia3 sites, 3 recruiting

89bio Clinical Study Site
Tbilisi, 0102
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Tbilisi, 0159
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Tbilisi, 0177
89bio Clinical Study Site
Recruiting

Other trials in Georgia

Hungary3 sites, 3 recruiting

89bio Clinical Study Site
Budapest, 01027
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Budapest, 01088
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Budapest, H-1097
89bio Clinical Study Site
Recruiting

Other trials in Hungary

Puerto Rico3 sites, 3 recruiting

89bio Clinical Study Site
Manati, 00674
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Mayagüez, 00680
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
San Juan, 00927
89bio Clinical Study Site
Recruiting

Other trials in Puerto Rico

Taiwan3 sites, 3 recruiting

89bio Clinical Study Site
Chiayi City, 60002
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Kaohsiung City, 80756
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Tainan, 00704
89bio Clinical Study Site
Recruiting

Other trials in Taiwan

Hong Kong2 sites, 2 recruiting

89bio Clinical Study Site
Hong Kong
89bio Clinical Study Site
Recruiting
89bio Clinical Study Site
Shatin
89bio Clinical Study Site
Recruiting

Other trials in Hong Kong

About this study

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)

The study will assess the efficacy and safety of pegozafermin administered in participants with biopsy-confirmed and clinically confirmed compensated cirrhosis due to MASH .

Conditions: Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis
Being tested: Pegozafermin, Placebo
Keywords: 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
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, RO7948410
Subcutaneous injection
PlaceboDrug
Subcutaneous injection

Study groups in NCT06419374
Study group	Role	What they receive
Pegozafermin	Experimental	Not described Receives: Biological: Pegozafermin
Placebo	Placebo comparator	Matched placebo Receives: Drug: Placebo

What is being measured

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

Proportion of Participants Achieving Fibrosis Regression
Fibrosis regression is defined as improvement in fibrosis by ≥1 stage, at Month 24 biopsy relative to baseline biopsy.
Measured: Baseline through Month 24
Time to First Occurrence of Disease Progression as Measured by Composite of Protocol -Specified Clinical Events
Measured: Baseline up to 5 years

Secondary outcomes (12)

Change from Baseline in Enhanced Liver Fibrosis (ELF) Score
Measured: Baseline, up to Month 60
Change from Baseline in Alanine Aminotransferase (ALT) Level
Measured: Baseline, up to Month 60
Change from Baseline in FibroScan Vibration-controlled Transient Elastography (VCTE)
Measured: Baseline, up to Month 60
Proportion of Participants who Develop Clinically Significant Portal Hypertension (CSPH)
Measured: Baseline, up to Month 60
Time to Progression to Large Gastric or Esophageal Varices or Endoscopic Treatment of Esophageal or Gastric Varices
Measured: Baseline, up to Month 60
Time to Clinically Important Ascites
Time to clinically important ascites as determined by the onset of Grade ≥2 (clinically apparent) ascites leading to diagnostic paracentesis or initiation of specific treatment for ascites.
Measured: Baseline, up to Month 60
Time to Overt Hepatic Encephalopathy
Measured: Baseline, up to Month 60
Frequency and Severity of Treatment-Emergent Adverse Events (TEAEs)
Measured: Baseline, up to 5 years
Frequency and Severity of Serious Adverse Events (SAEs)
Measured: Baseline, up to 5 years
Overall Frequency and Severity of Treatment-Related TEAEs
Measured: Baseline, up to Month 60
Overall Frequency and Severity of Treatment-Related SAEs
Measured: Baseline, up to Month 60
Proportion of Participants who Discontinue Treatment Due to Treatment-Related Adverse Events (AEs)
Measured: Baseline, up to Month 60

Timeline

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

24 May 202431 Aug 2031

First posted17 May 2024
Study start24 May 2024
Primary completion30 Jun 2028 (estimated)
Study completion31 Aug 2031 (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 Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated CirrhosisStudies 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: 1,800 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06419374
Sponsor's protocol ID: BIO89-100-132
Other IDs: GC46898
Status last verified: Oct 2026
First submitted: 14 May 2024
Last updated: 23 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing