mcbio. re " why is it that the MDGL drug did not raise liver enzymes in the P2 trial and, in fact, led to statistically significant reductions at higher doses? It would seem to me that the MDGL drug may be differentiated from the VKTX drug on this front."
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Agree ...IMHO MGL-3196 is differentiated ....its safer for one thing. Those long VKTX may be underestimating the risks of elevations in ALT especially when they run VK2809 in larger trials .
The P1 VKTX data I had referred to was a poster presentation in 2016 ..Cardiology conference I think
Note VKTX is running NCT02927184 ...a P2 for primary hypercholesterolemia and No- Alcohol Fatty Liver Disease enrolling 80 patients . They intended to have this completed in Dec 2017 but last update July 2017 , they were still enrolling
So we will have P 2 data MGL-3196 for He FH ....NCT03038022..before VKTX completes their P2 .
From MDGL re NCT03038022
Primary Outcome Measures:
Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) [ Time Frame: 12 Weeks ]
Secondary Outcome Measures:
Safety and tolerability of MGL-3196 based on Adverse Events and Changes in Laboratory Values [ Time Frame: 12 Weeks ]
Mean percent change from baseline on selected lipid parameters [ Time Frame: 12 Weeks ]
Non-high-density lipoprotein cholesterol (non-HDL-C),Apolipoprotein B (ApoB), Total cholesterol (TC)/high-density lipoprotein cholesterol (HDL-C) ratio, Triglycerides,Lipoprotein(a), Apolipoprotein A1 (ApoA1)/ApoB ratio, and Lipoprotein particle assessment
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What I would like to see are better numbers then Esperion's drug ..bempedoic acid .......combined with improvement in Liver enzymes
JMO
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