GC41033 A Phase II Study of BFKB8488A in patients with NASH
Research type
Research Study
Full title
A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TOEVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF BFKB8488A COMPAREDWITH PLACEBO IN PATIENTS WITH NON-ALCOHOLIC STEATOHEPATITIS.
IRAS ID
289465
Contact name
William Alazawi
Contact email
Sponsor organisation
Genentech Inc
Eudract number
2019-001897-27
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
2 years, 7 months, 0 days
Research summary
The participants taking part in this study have non-alcoholic steatohepatitis (NASH). NASH is a condition that occurs from having excess liver fat in combination with liver inflammation and cell damage. The main purpose of this study is to the safety and effects of the experimental study drug BFKB8488A compared with a placebo. The study drug will be administered via an injection under the skin (subcutaneous).
All Participants will be randomly placed into treatment groups, of which groups 1-4 will receive either a fixed dose of study drug (either 50mg, 75mg or 100mg) or a placebo. Group 5-6 will receive an individualised dose of study drug or a placebo; the individualised dose will start at 50mg of study drug with increases in dosage up to 130mg depending on individual tolerability.
About 260 participants aged between 18 and 75 years will participate globally in the study and in total participants will be in the study is around 16 months.
Unless an eligible liver biopsy is available then participants will need to undergo a liver biopsy before joining the study to confirm the diagnosis of NASH. The study will involve approximately 28 hospital visits every two weeks and one follow up visit. During these visits there will be a number of different procedures depending on which visit it is, these include but are not limited to reviewing medical history, completing questionnaires, physical examinations, blood samples, bone scans, MRI and Fibroscans. Each visit may take approximately 30 minutes to 2 hours, depending on the procedures for that visit.
Participants with diabetes will also have to perform home glucose testing and complete a glucose log.
Taking part in this study is entirely voluntary.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
21/EE/0132
Date of REC Opinion
24 Aug 2021
REC opinion
Further Information Favourable Opinion