ccc555,

It seems that you are either unfamiliar with the known effects of apabetalone on liver enzymes or you are intentionally trolling here. I am assuming the former. The cure for that is to educate yourself on the subject.

Long story short, the effects of apabetalone to mosly transiently raise liver enzymes was expected and extra monitoring was planned into the trial. No unexpected alarms through 9 DSMB checks. Some patients were expected to exceed the pre-set threshholds and there was a plan in place for these patients.

Here are a couple of posts of mine from the past the cover this subject. Read those posts to familiarize yourself with apabetalone and liver enzymes.

https://agoracom.com/ir/Resverlogix/forums/discussion/topics/729727-betonmace-and-aminotransferases/messages/2238547#message

https://agoracom.com/ir/Resverlogix/forums/discussion/topics/714650-fxr-and-liver-transaminase-related-adverse-events/messages/2206470#message

From the BETonMACE design paper below:

https://www.sciencedirect.com/science/article/abs/pii/S0002870319301978

"Because of the increased incidence of transaminase elevations with apabetalone in Phase 2 studies, frequent monitoring of liver safety was specified in the BETonMACE protocol. Liver function testing was performed at each follow-up visit, with the safety algorithm shown in Figure 3. If any measurement of ALT was elevated to more than 3 times the upper limit of normal (ULN) or total bilirubin was elevated to more than 2 times ULN, repeat testing was performed every 3-4 days until ALT was less than 1.5 times ULN or bilirubin was within normal limits, respectively. During repeat testing, study medication was continued if ALT was elevated to levels up to 5 times ULN, with suspension for any measurement of ALT more than 5 times ULN or total bilirubin more than 2 times ULN. If a second measurement of ALT was greater than 5 times ULN or a second measurement of bilirubin was greater than 2 times ULN, study medication was permanently discontinued. If study medication had been suspended due to ALT elevation that has a likely cause other than study medication, it could be resumed at 50 mg twice daily once ALT had returned to less than 1.5 times ULN and resumption had been approved by the medical monitors and sponsor. After resumption, additional liver function testing was performed according to the original study schedule. Suspension or continuation of statin therapy following ALT elevation was at the investigators’ discretion according to normal clinical practice."

BearDownAZ