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Posted On: 09/25/2024 12:37:48 PM
Post# of 154286
Ohm, I'm confused. In the March 5th webcast Dr. JL said:
As currently designed, the Inflammation Study will be a randomized, double blind, placebo-controlled trial comparing (2) doses of leronlimab in 90 study subjects. The study will enroll 45 cis-gender men & women and 45 transgender women. The subjects will become eligible to participate in the study after demonstrating evidence of required inflammation at screening as determined by elevated from normal C-Reactive Protein or CRP. Eligible subjects will then be randomized either 350, or 700mg weekly sub-q leronlimab or placebo and treated for 24 weeks.
The current Primary Endpoints to the study are C-Reactive Protein, CRP and another BioMarker of Inflammation called ENRAGE both of which were shown earlier signs of responding to leronlimab during our NASH trial. Given the exploratory nature of this study, we will also be evaluating the effect of leronlimab on a host of other secondary BioMarker endpoints as well.
Should we not be going after CRP as an endpoint? Am I misunderstanding or does Dr. JL think we did see a good response in the NASH study?
As currently designed, the Inflammation Study will be a randomized, double blind, placebo-controlled trial comparing (2) doses of leronlimab in 90 study subjects. The study will enroll 45 cis-gender men & women and 45 transgender women. The subjects will become eligible to participate in the study after demonstrating evidence of required inflammation at screening as determined by elevated from normal C-Reactive Protein or CRP. Eligible subjects will then be randomized either 350, or 700mg weekly sub-q leronlimab or placebo and treated for 24 weeks.
The current Primary Endpoints to the study are C-Reactive Protein, CRP and another BioMarker of Inflammation called ENRAGE both of which were shown earlier signs of responding to leronlimab during our NASH trial. Given the exploratory nature of this study, we will also be evaluating the effect of leronlimab on a host of other secondary BioMarker endpoints as well.
Should we not be going after CRP as an endpoint? Am I misunderstanding or does Dr. JL think we did see a good response in the NASH study?
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