UNITED LAB(03933): Phase II clinical study of first-class innovative drug UBT251 injection has been completed in Chinese type 2 diabetes patients.
Federal Pharmaceutical (03933) announced that its wholly-owned subsidiary, Federal Biotechnology (Zhuhai Hengqin) Co., Ltd., has completed Phase II clinical studies of the innovative drug UBT251 injection for type 2 diabetes patients in China.
United Lab (03933) announces that its wholly-owned subsidiary, Federal Biotechnology (Zhuhai Hengqin) Co., Ltd., has successfully completed Phase II clinical trials in Chinese type 2 diabetes patients for their innovative drug UBT251 injection.
The study was a randomized, double-blind, placebo-controlled trial, including 211 Chinese type 2 diabetes patients (who were either receiving lifestyle interventions alone or in combination with metformin). The patients had an average baseline glycosylated hemoglobin (HbA1c) level of 8.12%, baseline weight of 80.1 kg, and baseline BMI of 29.1 kg/m2. Patients were randomly assigned to receive subcutaneous injections of UBT251 once a week at doses of 2 mg, 4 mg, 6 mg, placebo, or 1 mg of semaglutide, for a continuous treatment period of 24 weeks. The main endpoint of the study was the change in HbA1c levels from baseline after 24 weeks of treatment.
The results of the study showed that after 24 weeks of treatment, the UBT251 treatment group had the highest average decrease in HbA1c levels at 2.16%, significantly better than the semaglutide group (1.77%) and the placebo group (0.66%). The UBT251 treatment group also had the highest average weight loss at 9.8%, compared to a 4.8% decrease in the semaglutide group and only 1.4% in the placebo group. Additionally, UBT251 showed improvements in key secondary endpoints including waist circumference, blood pressure, and lipid levels compared to the placebo group.
UBT251 demonstrated good safety and tolerability in the study, consistent with results observed in other phase II clinical trials for GLP agonists.
The successful completion of Phase II clinical trials for UBT251 injection in Chinese type 2 diabetes patients supports its progression to the next phase of clinical trials. The company will soon initiate Phase III clinical trials in Chinese type 2 diabetes patients.
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