Hanmi Pharm's Diabetes Treatment Efpeglenatide Receives Phase 3 IND Approval
Hanmi Pharm announced on January 21 that it has received approval from the Ministry of Food and Drug Safety for a domestic Phase 3 clinical trial plan (IND) for the development of 'HM11260C' (efpeglenatide), a treatment for type 2 diabetes.
This clinical trial is designed to confirm the efficacy and safety of HM11260C in patients with type 2 diabetes whose condition is not controlled by metformin and dapagliflozin.
The purpose of the trial is to demonstrate the superiority of HM11260C in blood glucose control compared to placebo when administered in combination, and to comparatively assess its safety.
The trial will be conducted as a multicenter, randomized, double-blind, placebo-controlled, parallel-design study involving 118 domestic patients.
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Hanmi Pharm stated in its announcement, "Through this clinical trial, we aim to develop HM11260C as a blood glucose control treatment for patients with type 2 diabetes."
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