The pharmaceutical finance circle was informed that recently, the phase IIb clinical trial of MDR-001, a small molecule oral new oral drug of Deruizhi Pharmaceutical, completed the first dose group administration.
This randomized, double-blind, placebo-controlled, multi-center Phase IIb clinical study aims to further evaluate the efficacy and safety of oral small molecule MDR-001 tablets for long-term administration in overweight or obese subjects, and to provide a basis for dose selection for the next Phase 3 clinical trial. The study, led by Professor Ji Linong of Peking University and jointly carried out by 19 centers, plans to enroll a total of 300 adult overweight or obese subjects.
MDR-001 completed the Phase I clinical single-dose ramp-up in the first half of ’23 and started the Phase Ib/IIa dose-finding study in September 2023. So far, the Phase Ib/IIa trial has been completed, and the results show that after taking MDR-001 for 12 weeks, the average weight of subjects decreased by 9.0% (placebo 2.1%), and the placebo decreased by 6.9% on average, of which 87% of subjects lost more than 5% of body weight. The most commonly reported treatment-period adverse events were mild to moderate gastrointestinal adverse events.
