UNITED LAB (03933) announced that the Phase II clinical study for its independently developed Class 1 innovative drug, UBT251 injection, has been completed in Chinese patients with overweight or obesity conditions. The trial was conducted by the company's wholly-owned subsidiary, Federal Biotech (Zhuhai Hengqin) Co., Ltd.
This randomized, double-blind, parallel, placebo-controlled study enrolled 205 participants who were either obese (BMI≥28.0 kg/m²) or overweight (24.0 kg/m² ≤BMI<28.0 kg/m²) with at least one weight-related comorbidity. The baseline average weight of participants was 92.2 kg, with an average BMI of 33.1 kg/m².
Participants were randomly assigned in a 1:1:1:1 ratio to receive either UBT251 injection at doses of 2 mg, 4 mg, or 6 mg, or a placebo. All received subcutaneous injections once weekly for 24 consecutive weeks. The primary endpoint was the percentage change in body weight from baseline after 24 weeks of treatment.
Study results demonstrated significant weight reduction effects across all UBT251 dose groups. After 24 weeks of treatment, the highest average weight reduction reached -19.7% (-17.5 kg) in the treatment groups, compared to -2.0% (-1.6 kg) in the placebo group.
Additionally, all UBT251 dose groups showed significantly greater improvements in key secondary endpoints including waist circumference, blood glucose, blood pressure, and blood lipid levels compared to the placebo group.
The treatment demonstrated favorable overall safety and tolerability across all dosage groups, with no participant withdrawals due to adverse events. Reported adverse events were similar to those of comparable drugs, primarily consisting of gastrointestinal reactions that were mostly mild to moderate in severity. No unexpected safety concerns were identified.
The successful completion of the Phase II clinical study for UBT251 injection in overweight/obese patients has achieved its intended objectives, supporting advancement to the next clinical development phase. The company plans to promptly initiate Phase III clinical studies in Chinese patients with overweight or obesity conditions.
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