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A study of a new medicine (fazpilodemab) in people with a type of liver disease called non-alcoholic steatohepatitis or NASH
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BFKB8488A Compared With Placebo in Participants With Non-Alcoholic Steatohepatitis
Metabolic Disorder Non Alcoholic Steato-Hepatitis Kidney Disorder Chronic Kidney Disease
- For Medical Professional
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Basic Details
Sponsor
Genentech, Inc. (A part of F. Hoffmann-La Roche Ltd., Switzerland)
Phase
Phase 2
Study Identifier
NCT04171765, GC41033
Condition
Non-alcoholic Steatohepatitis
Official Title
A Phase II, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BFKB8488A Compared With Placebo in Patients With Non-Alcoholic Steatohepatitis
Study Summary
This study will evaluate the efficacy, safety, and pharmacokinetics of BFKB8488A compared to placebo in participants with non-alcoholic steatohepatitis (NASH).
Eligibility Criteria
All
≥18 Years & ≤ 75 Years
No
Inclusion Criteria
- Confirmed diagnosis of NASH as documented through liver biopsy performed no more than 6 months before randomization, defined according to NASH CRN criteria along with a NASH CRN fibrosis score between F2 and F3
- Hepatic steatosis on MRI (>= 8% average PDFF) prior to randomization
Exclusion Criteria
- History of any liver disease other than NASH, except for resolved, self-limited illnesses such as Hepatitis A or E, and previous Hepatitis C
- Weight gain > 10% or loss > 5% within 3 months prior to randomization
- History of liver transplantation
- Current or history of significant alcohol consumption
This page summarises information from public registry websites, such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. To learn more about this study, see the For Medical Professional tab or visit one of those websites.
The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
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Study results
LPS GC41033 Final Results February 2024 English
(PDF, 0.2 MB)
LPS GC41033 Final Results February 2024 French
(PDF, 0.2 MB)
LPS GC41033 Final Results February 2024 Spanish
(PDF, 0.2 MB)
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For the latest version of this information please go to www.forpatients.roche.com