Transition Therapeutics begins TT-401 Phase 2 clinical study for treatment of type 2 diabetes

May 15 2014

Transition Therapeutics Inc. ("Transition" or the "Company") (NASDAQ: TTHI, TSX: TTH) today announced the dosing of the first patient in a Phase 2 clinical study of TT-401 (LY2944876), a drug candidate for the treatment of type 2 diabetes. The study is expected to enroll up to 375 type 2 diabetes subjects and will be performed by Transition's development partner, Eli Lilly and Company ("Lilly"). The objectives of the study will be to evaluate the safety and effectiveness of TT-401 compared to once-weekly exenatide extended release and placebo.

The randomized, 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, where neither the participant nor the investigator will know which treatment each individual is assigned. Thereafter follows a 12-week period (weeks 13-24) 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 13-24, and those who received placebo will be followed without treatment.

The main efficacy outcome measures will be the change in HbA1c (a measure of blood-glucose levels) at week 12 and 24 and change in body weight over the course of the study. Additional information on the study and participation can be found at clinicaltrials.gov under study# NCT02119819.