Dosing Begins In TT-401 Phase II Type II Diabetes Study
The first patient has been dosed in a Phase II study of Transition Therapeutics' lead metabolic drug candidate TT-401 (LY2944876), being developed for the treatment of Type II diabetes. The study is expected to enrol up to 375 Type II diabetes subjects and will be performed by Transition's development partner, Eli Lilly. The objectives of the study will be to evaluate the safety and effectiveness of TT-401 compared with once weekly exenatide extended release and placebo.
The randomised, double-blind, placebo-controlled study will include six study arms, four doses of TT-401, a placebo arm and a once-weekly exenatide arm. The study will include a 12-week blinded treatment period. Thereafter follows a 12-week period (weeks 13 to 24) where participants and the investigator will know which treatment they are assigned to. Participants on TT-401 and on once weekly exenatide will continue treatment through weeks 13 to 24, and those who received placebo will be followed without treatment.
The main efficacy outcome measures will be the change in HbA1c at week 12 and 24, and change in body weight over the course of the study.