Transition: First Patient Dosed In Phase 2 Study Of TT-401 In Type 2 Diabetes

(RTTNews) - Transition Therapeutics Inc. (TTHI, TTH.TO) 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 (LLY). 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.