THR1442: Phase II data

A 96-week, double-blind, international Phase II trial in 288 Type II diabetics inadequately controlled by diet and exercise and up to 1 oral anti-diabetic agent showed that oral THR1442 met the primary endpoint of reducing HbA1c from baseline to week 24 vs. placebo (placebo-adjusted reduction of 0.79%, p<0.0001). At week 96, THR1442 led to a significant placebo-adjusted reduction in HbA1c of 1.02% from baseline (p<0.0001). THR1442 also met the secondary endpoints of a greater proportion of patients achieving an HbA1c of <7% at week 24 (24% vs. 11%, p=0.0041) and at week 96 (31% vs. 11%, p<0.0001) vs. placebo. No severe hypoglycemic events were observed. Patients receiving THR1442 also achieved "meaningful and sustained reductions" in SBP and DBP, as well as "significant and durable" weight loss. ...