Some radical changes to the NASH trial
Post# of 148175
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Posted On: 08/31/2021 11:22:34 AM
Some radical changes to the NASH trial
Most important is that NASH phase 2 has begun recruiting.
Changes:
Now 60 patients instead of 90.
Now 2 arm instead of 3 arm.
Now 700mg subQ for all instead of 525 and 700
Primary endpoint now "change from baseline in hepatic fat fraction assessed by magnetic resonance imaging-derived protondensity fat fraction (MRI-PDFF) at week 14" instead of incidence of adverse events and tolerability (is this simply upgrade from phase 1 to 2?).
Added another MRI test to secondary endpoints and inflammatory marker analyses: IL-6, RANTES, etc...
Surpised to see ALT, AST moved from secondary to other outcomes. Changes in these levels are standard NASH endpoints.
Easy way to see changes:
https://clinicaltrials.gov/ct2/history/NCT045...udyPageTop
Most important is that NASH phase 2 has begun recruiting.
Changes:
Now 60 patients instead of 90.
Now 2 arm instead of 3 arm.
Now 700mg subQ for all instead of 525 and 700
Primary endpoint now "change from baseline in hepatic fat fraction assessed by magnetic resonance imaging-derived protondensity fat fraction (MRI-PDFF) at week 14" instead of incidence of adverse events and tolerability (is this simply upgrade from phase 1 to 2?).
Added another MRI test to secondary endpoints and inflammatory marker analyses: IL-6, RANTES, etc...
Surpised to see ALT, AST moved from secondary to other outcomes. Changes in these levels are standard NASH endpoints.
Easy way to see changes:
https://clinicaltrials.gov/ct2/history/NCT045...udyPageTop
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