ConjuChem has initiated patient enrolment in a Phase II clinical trial of its proprietary GLP-1 receptor agonist drug CJC-1134-PC in patients with type 2 diabetes who are receiving metformin monotherapy.
The randomised, double-blind and placebo-controlled dose-ranging study will involve up to 225 patients, and will evaluate the safety and efficacy of weekly injections of CJC-1134-PC for a period of 17 weeks.
In the trial, the pharmacokinetic and pharmacodynamic relationship of CJC-1134-PC and glycosylated haemoglobin (HbA1c) or fasting plasma glucose will also be evaluated.
Results of the Phase II study will be used to establish the optimal dose for planned Phase III studies, the company said.
ConjuChem CEO Patrick Soon-Shiong said the data from previous studies have been very promising, demonstrating a positive tolerability profile and initial efficacy, as assessed by the reduction of haemoglobin following a once per week dosing.