About 375 patients with type 2 diabetes are expected to be enrolled in the trial, which will be performed by the company’s development partner, Eli Lilly and Company.
Objectives of the randomized, double-blind, placebo-controlled trial will be to assess the safety and effectiveness of TT-401 compared to once-weekly exenatide extended release and placebo.
The trial will include six study arms, four doses of TT-401, a placebo arm and a once-weekly exenatide arm.
It will also include a 12-week blinded treatment period, where neither the participant nor the investigator will know which treatment each individual is assigned.
After the 12-week blinded treatment period, a 12-week period (weeks 13-24) will be followed where participants and the investigator will know which treatment they are assigned to.
The company said that patients on TT-401 as well as on once-weekly exenatide will continue treatment through weeks 13-24, and those who received placebo will be followed without treatment.
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 trial.
HbA1c is a measure of blood-glucose levels.
Image: Transition’s Phase II trial of diabetes drug candidate TT-401 will be performed by Eli Lilly. Photo: courtesy of tungphoto/ freedigitalphotos.net