UNITED LAB's UBT251 Injection Reaches Key Milestone in Phase III Diabetes Trial

Stock News09-07

UNITED LAB (03933) has announced that its wholly-owned subsidiary, United Bioscience (Zhuhai Hengqin) Co., Ltd., has successfully completed the first participant dosing in the Phase III clinical study of its independently developed Class 1 innovative drug, UBT251 injection, for the treatment of type 2 diabetes in China.

The clinical research will be conducted through two separate trials, designated as UNIGUIDE-1 and UNIGUIDE-2. UNIGUIDE-1 employs a randomized, double-blind, parallel, placebo-controlled design and aims to enroll 360 adult participants with type 2 diabetes (7.5% ≤ HbA1c ≤ 10.5%). This study is intended to evaluate the efficacy and safety of UBT251 injection in patients whose blood glucose control remains inadequate despite lifestyle intervention involving diet and exercise alone.

The primary endpoint of UNIGUIDE-1 is the change from baseline in HbA1c levels after 40 weeks of treatment. UNIGUIDE-2 adopts a randomized, open-label, parallel, active-controlled design against semaglutide injection, with plans to enroll 956 adult participants with type 2 diabetes (7.5% ≤ HbA1c ≤ 11.0%). This trial focuses on evaluating the efficacy and safety of UBT251 injection in patients whose glycemic control is insufficient after treatment with metformin monotherapy or metformin combined with sulfonylureas or sodium-glucose cotransporter 2 (SGLT2) inhibitors. The primary endpoint for UNIGUIDE-2 is also the change from baseline in HbA1c after 40 weeks, with secondary endpoints including body weight, blood pressure, lipid profile, and HbA1c changes from baseline at the 52-week mark.

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