A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BFKB8488A Compared With Placebo in Participants With Non-Alcoholic Steatohepatitis
NCT ID: NCT04171765
Last Updated: 2024-04-16
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
46 participants
INTERVENTIONAL
2020-09-30
2023-01-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Participants will receive a fixed dose of placebo matched to BFKB8488A.
Placebo
Participants will receive subcutaneous (SC) placebo matched to BFKB8488A.
Fixed Dose: BFKB8488A Dose A
Participants will receive BFKB8488A.
BFKB8488A
Participants will receive subcutaneous (SC) BFKB8488A.
Fixed Dose: BFKB8488A Dose B
Participants will receive BFKB8488A.
BFKB8488A
Participants will receive subcutaneous (SC) BFKB8488A.
Fixed Dose: BFKB8488A Dose C
Participants will receive BFKB8488A.
BFKB8488A
Participants will receive subcutaneous (SC) BFKB8488A.
Interventions
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Placebo
Participants will receive subcutaneous (SC) placebo matched to BFKB8488A.
BFKB8488A
Participants will receive subcutaneous (SC) BFKB8488A.
Eligibility Criteria
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Inclusion Criteria
* Hepatic steatosis on MRI (\>= 8% average PDFF) prior to randomization
Exclusion Criteria
* Weight gain \> 10% or loss \> 5% within 3 months prior to randomization
* History of liver transplantation
* Current or history of significant alcohol consumption
18 Years
75 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Cullman Clinical Trials
Cullman, Alabama, United States
Arizona Liver Health - Chandler
Chandler, Arizona, United States
Arizona Liver Health - Tucson
Tucson, Arizona, United States
Orange Grove Family Practice
Tucson, Arizona, United States
Arkansas Gastroenterology
North Little Rock, Arkansas, United States
Gregory Wiener, MD
Chula Vista, California, United States
Community Cancer Institute (CCI)
Fresno, California, United States
National Research Inst.
Los Angeles, California, United States
Conquest Clinical Research
Orange, California, United States
UC San Diego Airway Research and Clinical Trials Center
San Diego, California, United States
National Research Institute - Panorama City
Santa Monica, California, United States
South Denver Gastroenterology
Englewood, Colorado, United States
Excel Medical Research
Boca Raton, Florida, United States
Premier Research Associate, Inc
Miami, Florida, United States
Covenant Research
Sarasota, Florida, United States
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia, United States
Grand Teton Research Group, PLLC
Idaho Falls, Idaho, United States
Gastroenterology Associates, LLC
Baton Rouge, Louisiana, United States
Avant Research Associates, LLC
Crowley, Louisiana, United States
Walter Reed Army Medical Center
Bethesda, Maryland, United States
Huron Gastroenterology Associates
Ypsilanti, Michigan, United States
Kansas City Research Institute, LLC
Kansas City, Missouri, United States
Amici Clinical Research
Raritan, New Jersey, United States
Duke Medical Center; Gen Clinic Research Ctr
Durham, North Carolina, United States
Wexner Medical Center; Ohio State University; Investigational Drug Services; Pharmacy Department
Columbus, Ohio, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Pinnacle Clinical Research - Austin
Austin, Texas, United States
Texas Digetive Disease Consultants - Austin
Cedar Park, Texas, United States
Liver Institute at Renaissance
Edinburg, Texas, United States
South Texas Research Institute
Edinburg, Texas, United States
Texas Digestive Disease Consultant - Ft Worth (TDDC - Ft Worth)
Fort Worth, Texas, United States
Liver Associates of Texas - Houston
Houston, Texas, United States
Quality Research Inc
San Antonio, Texas, United States
American Research Corporation Inc.
San Antonio, Texas, United States
Clinical Trials of Texas, Inc
San Antonio, Texas, United States
Pinnacle Clinical Research - San Antonio
San Antonio, Texas, United States
Texas Digestive Disease Consultants - San Marcos
San Marcos, Texas, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Hunter Holmes McGuire V.A. Medical Center
Richmond, Virginia, United States
Hospital Erasme
Brussels, , Belgium
Antwerp University Hospital
Edegem, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
CHU Hopitaux de Bordeaux
CHU Hopitaux de Bordeaux, , France
Hospices Civils de Lyon
Lyon, , France
CHU de Nice
Nice, , France
Hopital Pitie-Salpetriere APHP
Paris, , France
Hôpital d'Enfants, Service d?onco-hématologie pédiatrique
Vandœuvre-lès-Nancy, , France
Fundacion de Investigacion de Diego
San Juan, , Puerto Rico
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Universtiario Virgen del Rocio
Seville, , Spain
Hospital Clinico Universitario de Valencia; Servicio de Anatomia Patologica
Valencia, , Spain
Consorcio Hospital General Universitario de Valencia
Valencia, , Spain
Hospital Universitari i Politecnic La Fe; Servicio de Neurología
Valencia, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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GC41033
Identifier Type: -
Identifier Source: org_study_id
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