Federal Pharmaceuticals (03933): UBT251 injection completed administration to participants in the first phase III clinical study of type 2 diabetes in China

Zhitongcaijing · 1d ago

Zhitong Finance App News, Federal Pharmaceutical (03933) announced that the Class 1 innovative drug UBT251 injection independently developed by the Company's wholly-owned subsidiary Federal Biotechnology (Zhuhai Hengqin) Co., Ltd. (“Federation Biotechnology”) has completed administration to participants in the first phase III clinical study of type 2 diabetes in China. This study will conduct two studies, “UNIGUIDE-1” and “UNIGUIDE-2,” respectively.

Using a randomized, double-blind, parallel, placebo-controlled trial design, UNIGUIDE-1 is planned to include 360 adult type 2 diabetes trial participants (7.5% ≤ HbA1c ≤ 10.5%) to evaluate the efficacy and safety of UBT251 injections in type 2 diabetes trial participants with poor blood sugar control after simple diet and exercise intervention. The primary evaluation endpoint for UNIGUIDE-1 was changes in HbA1c compared to baseline after 40 weeks of treatment.

UNIGUIDE-2 Using a randomized, open, parallel, simeglutide injection-controlled trial design, it is planned to include 956 adult type 2 diabetes trial participants (7.5% ≤ HbA1c ≤ 11.0%) to evaluate the efficacy and safety of UBT251 injections in participants with poor glycemic control after treatment with metformin monotherapy or a combination of sulfonylurea/sodium-glucose co-transporter 2 (SGLT2) inhibitors. The main evaluation endpoints for UNIGUIDE-2 were changes in HbA1c compared to baseline after 40 weeks of treatment. Secondary evaluation endpoints included changes in body weight, blood pressure, and blood lipids, and changes in HbA1c compared to baseline after 52 weeks of treatment.