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CytoDyn Inc CYDY
(Total Views: 600)
Posted On: 08/31/2021 11:22:34 AM
Post# of 155026
Posted By: generactor
Re: docj #101963
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














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