vTv Therapeutics announced positive topline results from the Phase 2b AGATA study of the glucokinase activator, TTP399, for the treatment of Type 2 diabetes.
AGATA (Add Glucokinase Activator to Target A1c) was a double-blind, placebo- and active-controlled, parallel group clinical trial evaluating TTP399 in 190 patients with Type 2 diabetes on a stable dose of metformin. The primary endpoint was change from baseline in HbA1c at 6 months.
The study met its primary endpoint, showing that treatment with TTP399 800mg daily achieved statistically significant change from baseline in HbA1c at 6 months compared to placebo. A dose-dependent reduction in HbA1c was observed, which was sustained throughout the study. Additionally, TTP399 was found to have a tolerable safety profile. Further analysis of the study is ongoing.
TTP399 is an oral, small molecule, liver-selective glucokinase (GK) activator. Selective activation of glucokinase, a key regulator of glucose homeostasis, increases GK activity thereby improving glycemic control in Type 2 diabetes without disrupting the interaction between GK and glucokinase regulatory protein (GKRP).
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