Hanmi Pharmaceutical Begins First Dosing in Phase 3 Diabetes Trial for Obesity Drug Efpeglenatide

Targeting Korean Patients with Type 2 Diabetes

Hanmi Pharmaceutical has begun the first dosing in a domestic Phase 3 clinical trial to expand the diabetes indication for its independently developed GLP-1 new drug, efpeglenatide.

Exterior view of Hanmi Group headquarters. Hanmi Group

On May 18, Hanmi Pharmaceutical announced that it has started administering the first dose to a participant in a Phase 3 clinical trial evaluating the blood glucose control efficacy of a combination therapy of efpeglenatide, metformin, and the SGLT2 inhibitor dapagliflozin in Korean patients with type 2 diabetes.

This Phase 3 clinical trial, approved by the Ministry of Food and Drug Safety on January 21, 2026, is designed to compare the efficacy and safety of efpeglenatide in combination with metformin and dapagliflozin versus placebo in type 2 diabetes patients whose blood glucose is not adequately controlled with metformin and dapagliflozin alone. The Phase 3 study will be conducted as a multicenter, randomized, double-blind, placebo-controlled trial targeting Korean patients, with study completion expected by 2028.

Efpeglenatide utilizes Hanmi Pharmaceutical’s proprietary platform technology, ‘LAPSCOVERY.’ Previously, a global clinical trial involving approximately 6,000 patients with type 2 diabetes was conducted in partnership with a global partner, and the company reported that, in addition to weight loss and blood glucose control effects, potential cardiovascular and renal protective benefits were also confirmed. Related research findings have been published in the New England Journal of Medicine (NEJM) and Circulation.

Hanmi Pharmaceutical regards obesity as a complex metabolic disease leading to type 2 diabetes and cardiovascular diseases, and is implementing a Life Cycle Management (LCM) strategy to expand the scope of efpeglenatide. In addition to the diabetes indication, the company is also considering diversifying formulations, such as autoinjectors and pre-filled syringes, and combining with digital therapeutics (DTx) models.

Nayoung Kim, Head of Innovation Growth at Hanmi Pharmaceutical, stated, "Efpeglenatide is an innovative new drug with the potential to expand its therapeutic scope beyond obesity to various metabolic diseases, including diabetes, cardiovascular, and renal diseases. Through this combination Phase 3 trial, we aim to clearly demonstrate efpeglenatide's blood glucose control ability and will continue to accumulate clinical evidence for its use as an 'integrated metabolic disease treatment' going forward."

This content was produced with the assistance of AI translation services.