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

NCT ID: NCT06419374

Last Updated: 2026-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

762 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-24

Study Completion Date

2031-08-31

Brief Summary

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

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Pegozafermin

Group Type EXPERIMENTAL

Pegozafermin

Intervention Type BIOLOGICAL

Subcutaneous injection

Placebo

Matched placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Subcutaneous injection

Interventions

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Pegozafermin

Subcutaneous injection

Intervention Type BIOLOGICAL

Placebo

Subcutaneous injection

Intervention Type DRUG

Other Intervention Names

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BIO89-100

Eligibility Criteria

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Inclusion Criteria

* 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.
* Biopsy-confirmed fibrosis stage F4 MASH (NASH Clinical Research Network (CRN) system) with compensated cirrhosis.
* Body mass index (BMI) at screening ≥25.0 (≥23.0 for Asian participants) and \<50.0 kilograms (kg)/meters squared (m\^2).

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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89bio, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maya Margalit, MD

Role: STUDY_DIRECTOR

89bio, Inc.

Locations

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89bio Clinical Study Site

Birmingham, Alabama, United States

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89bio Clinical Study Site

Homewood, Alabama, United States

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89bio Clinical Study Site

Chandler, Arizona, United States

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89bio Clinical Study Site

Flagstaff, Arizona, United States

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89bio Clinical Study Site

Peoria, Arizona, United States

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89bio Clinical Study Site

Phoenix, Arizona, United States

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89bio Clinical Study Site

Tucson, Arizona, United States

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Tucson, Arizona, United States

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Tucson, Arizona, United States

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Little Rock, Arkansas, United States

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North Little Rock, Arkansas, United States

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Camarillo, California, United States

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Canoga Park, California, United States

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Coronado, California, United States

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89bio Clinical Study Site

Fountain Valley, California, United States

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Fresno, California, United States

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Huntington Park, California, United States

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La Jolla, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Pasadena, California, United States

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Poway, California, United States

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Redwood City, California, United States

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Rialto, California, United States

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Sacramento, California, United States

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Santa Ana, California, United States

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Littleton, Colorado, United States

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Clermont, Florida, United States

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Fort Myers, Florida, United States

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Gainesville, Florida, United States

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Hialeah Gardens, Florida, United States

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Homestead, Florida, United States

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Jacksonville, Florida, United States

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Lady Lake, Florida, United States

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Lakewood Rch, Florida, United States

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Lehigh Acres, Florida, United States

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Maitland, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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New Port Richey, Florida, United States

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Ocala, Florida, United States

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Ocoee, Florida, United States

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Orlando, Florida, United States

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University Park, Florida, United States

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Viera, Florida, United States

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Winter Park, Florida, United States

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Athens, Georgia, United States

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Atlanta, Georgia, United States

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Chicago, Illinois, United States

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Hammond, Indiana, United States

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New Albany, Indiana, United States

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South Bend, Indiana, United States

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Iowa City, Iowa, United States

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Kansas City, Kansas, United States

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Topeka, Kansas, United States

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Lafayette, Louisiana, United States

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Baltimore, Maryland, United States

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Glen Burnie, Maryland, United States

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Greenbelt, Maryland, United States

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Burlington, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Clinton Township, Michigan, United States

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Detroit, Michigan, United States

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Wyoming, Michigan, United States

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Ypsilanti, Michigan, United States

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Minneapolis, Minnesota, United States

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Rochester, Minnesota, United States

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Flowood, Mississippi, United States

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Tupelo, Mississippi, United States

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St Louis, Missouri, United States

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Las Vegas, Nevada, United States

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Florham Park, New Jersey, United States

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Somers Point, New Jersey, United States

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Albuquerque, New Mexico, United States

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New York, New York, United States

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New York, New York, United States

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New York, New York, United States

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Asheville, North Carolina, United States

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Durham, North Carolina, United States

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Fayetteville, North Carolina, United States

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Greenville, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Akron, Ohio, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Dayton, Ohio, United States

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Liberty Township, Ohio, United States

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Westlake, Ohio, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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East Greenwich, Rhode Island, United States

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Charleston, South Carolina, United States

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Columbia, South Carolina, United States

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Rapid City, South Dakota, United States

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Cordova, Tennessee, United States

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Hermitage, Tennessee, United States

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Nashville, Tennessee, United States

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Austin, Texas, United States

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Austin, Texas, United States

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Austin, Texas, United States

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Brownsville, Texas, United States

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DeSoto, Texas, United States

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Edinburg, Texas, United States

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Farmers Branch, Texas, United States

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Fort Worth, Texas, United States

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Harlingen, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Lubbock, Texas, United States

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Pearland, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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San Marcos, Texas, United States

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Waco, Texas, United States

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Waco, Texas, United States

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Sandy City, Utah, United States

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West Jordan, Utah, United States

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Richmond, Virginia, United States

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Richmond, Virginia, United States

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Richmond, Virginia, United States

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Richmond, Virginia, United States

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Seattle, Washington, United States

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Seattle, Washington, United States

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89bio Clinical Study Site

Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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89bio Clinical Study Site

Buenos Aires, , Argentina

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89bio Clinical Study Site

Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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CABA, , Argentina

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Capital Federal, , Argentina

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Pilar, , Argentina

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Adelaide, , Australia

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Fitzroy, , Australia

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Greenslopes, , Australia

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Heidelberg, , Australia

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Herston, , Australia

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Murdoch, , Australia

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Perth, , Australia

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South Brisbane, , Australia

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Brussels, , Belgium

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Brussels, , Belgium

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Brussels, , Belgium

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89bio Clinical Study Site

Edegem, , Belgium

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Genk, , Belgium

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89bio Clinical Study Site

Ghent, , Belgium

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Roeselare, , Belgium

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Barretos, , Brazil

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Belo Horizonte, , Brazil

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Botucatu, , Brazil

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Goiânia, , Brazil

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Porto Alegre, , Brazil

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Salvador, , Brazil

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São José do Rio Preto, , Brazil

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Gorna Oryahovitsa, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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89bio Clinical Study Site

Stara Zagora, , Bulgaria

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Calgary, Alberta, Canada

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89bio Clinical Study Site

Vancouver, British Columbia, Canada

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89bio Clinical Study Site

Vancouver, British Columbia, Canada

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89bio Clinical Study Site

Winnipeg, Manitoba, Canada

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89bio Clinical Study Site

London, Ontario, Canada

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89bio Clinical Study Site

Ottawa, Ontario, Canada

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89bio Clinical Study Site

Toronto, Ontario, Canada

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89bio Clinical Study Site

Vaughan, , Canada

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89bio Clinical Study Site

Amiens, , France

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Dijon, , France

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Limoges, , France

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Lyon, , France

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Montpellier, , France

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Nice, , France

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Paris, , France

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Paris, , France

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Paris, , France

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Pessac, , France

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Strasbourg, , France

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Toulouse, , France

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Vandœuvre-lès-Nancy, , France

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Vénissieux, , France

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Villejuif, , France

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Chemnitz, , Germany

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Frankfurt, , Germany

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Freiburg im Breisgau, , Germany

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Hanover, , Germany

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Homburg, , Germany

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Münster, , Germany

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Hong Kong, , Hong Kong

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89bio Clinical Study Site

Shatin, , Hong Kong

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Budapest, , Hungary

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89bio Clinical Study Site

Budapest, , Hungary

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Budapest, , Hungary

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Afula, , Israel

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Beersheba, , Israel

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Haifa, , Israel

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Haifa, , Israel

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Jerusalem, , Israel

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Nahariya, , Israel

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Petah Tikva, , Israel

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Tel Aviv, , Israel

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Tel Litwinsky, , Israel

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Bergamo, , Italy

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Foggia, , Italy

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Milan, , Italy

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Milan, , Italy

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Novara, , Italy

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Palermo, , Italy

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Roma, , Italy

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Rome, , Italy

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Rozzano, , Italy

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Torino, , Italy

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Chihuahua City, , Mexico

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Cuautitlán Izcalli, , Mexico

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Cuernavaca, , Mexico

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Jalisco, , Mexico

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Mexico City, , Mexico

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Mexico City, , Mexico

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Mérida, , Mexico

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Monterrey, , Mexico

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Amsterdam, , Netherlands

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Rotterdam, , Netherlands

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Tilburg, , Netherlands

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Utrecht, , Netherlands

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Katowice, , Poland

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Krakow, , Poland

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Lodz, , Poland

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Lodz, , Poland

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Mysłowice, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Wroclaw, , Poland

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Singapore, , Singapore

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Singapore, , Singapore

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Singapore, , Singapore

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Singapore, , Singapore

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Bucheon-si, , South Korea

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Busan, , South Korea

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Daegu, , South Korea

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Daegu, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Almería, , Spain

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Badalona, , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Córdoba, , Spain

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Madrid, , Spain

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Málaga, , Spain

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Pontevedra, , Spain

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Santander, , Spain

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Santiago de Compostela, , Spain

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Zaragoza, , Spain

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Chiayi City, , Taiwan

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Kaohsiung City, , Taiwan

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Tainan, , Taiwan

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Bornova, İzmir, Turkey (Türkiye)

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Merkez, Rize Province, Turkey (Türkiye)

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Ankara, , Turkey (Türkiye)

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Ankara, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Yüreğir, , Turkey (Türkiye)

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Aberdeen, , United Kingdom

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Bristol, , United Kingdom

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Hants, , United Kingdom

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Leeds, , United Kingdom

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London, , United Kingdom

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89bio Clinical Study Site

London, , United Kingdom

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89bio Clinical Study Site

London, , United Kingdom

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London, , United Kingdom

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Oxford, , United Kingdom

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Plymouth, , United Kingdom

Site Status RECRUITING

89bio Clinical Study Site

Port Talbot, , United Kingdom

Site Status RECRUITING

89bio Clinical Study Site

Southampton, , United Kingdom

Site Status RECRUITING

Countries

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United States Argentina Australia Belgium Brazil Bulgaria Canada France Germany Hong Kong Hungary Israel Italy Mexico Netherlands Poland Singapore South Korea Spain Taiwan Turkey (Türkiye) United Kingdom

Central Contacts

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ENLIGHTEN clinical trial

Role: CONTACT

[email protected]
1-415-432-9270

Facility Contacts

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Other Identifiers

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BIO89-100-132

Identifier Type: -

Identifier Source: org_study_id

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