AZ launches P3T for oral obesity, diabetes drug in Korea

MFDS approves 6 trials, including 5 for oral GLP-1 ‘elecoglipron’ and 1 for amylin analog ‘AZD6234’

10.5% weight loss identified at 26 weeks in ADA 2026 data…Phase III studies span obesity, diabetes and Forxiga combination therapy

AstraZeneca (AZ) has set out to initiate large-scale global Phase III trials in Korea involving its next-generation oral obesity and diabetes drug candidate ‘elecoglipron (AZD5004).’

According to the Ministry of Food and Drug Safety (MFDS) on the 19th, AstraZeneca Korea received approval on the 18th for 6 multinational Phase III trials—5 involving the oral GLP-1 (glucagon-like peptide-1) receptor agonist ‘elecoglipron’ and 1 involving the long-acting amylin analog ‘AZD6234.’

With the approvals, AstraZeneca will begin enrolling Korean patients at major tertiary hospitals for its global Embold master clinical program in patients with obesity or overweight and its Eluminate-1, 2, 3 and 5 trials in patients with type 2 diabetes.

Elecoglipron is an oral small-molecule compound licensed by AstraZeneca from Chinese biotech company Eccogene. The drug is considered a key pipeline asset and a potential game-changer in the obesity and diabetes market, currently dominated by injectable treatments such as Wegovy and Mounjaro, given its convenience of oral administration.

According to Phase IIb results presented at the recent American Diabetes Association 2026 Scientific Sessions (ADA 2026), the 75 mg elecoglipron arm achieved an average weight reduction of 10.5% at 26 weeks and 11.8% at 36 weeks of follow-up in a study on patients with obesity or overweight patients (VISTA) Also, in the SOLSTICE study involving patients with type 2 diabetes, elecoglipron reduced HbA1c by an average 1.9 percentage points at 26 weeks, with 85% of patients reaching the target HbA1c level of 6.5% or lower. In terms of safety, no notable liver safety issues were identified beyond mild-to-moderate gastrointestinal adverse events similar to those seen with existing GLP-1 class drugs.

Among the Phase III programs approved in Korea, the Eluminate program will evaluate elecoglipron across a broad range of treatment settings, including its use as monotherapy as well as combination therapy with AstraZeneca’s SGLT-2 inhibitor Forxiga (dapagliflozin) (Eluminate-1 and 5), treatment in patients receiving background insulin therapy (Eluminate-3), and a head-to-head comparison with the standard oral semaglutide (Eluminate-2).

AstraZeneca also received approval on the same day for SELENE 1, a Phase III trial of AZD6234 in non-diabetic people with obesity or overweight. The approvals are expected to accelerate the company’s diversification of its obesity pipeline with next-generation mechanisms of action.

The trials will be conducted at multiple major Korean hospitals, including Asan Medical Center, Severance Hospital, Seoul National University Hospital, Seoul National University Bundang Hospital, Samsung Medical Center and Seoul St. Mary’s Hospital.

The global obesity and diabetes treatment market is currently led by Novo Nordisk’s Wegovy and Eli Lilly’s Mounjaro. Competition for market leadership is expected to intensify as global pharmaceutical companies, including AstraZeneca, Roche and Zealand Pharma, increasingly pursue next-generation therapies with novel mechanisms and oral therapies that substantially improve treatment convenience.

Among Korean pharmaceutical companies, Hanmi Pharmaceutical is preparing to launch its GLP-1 obesity treatment efpeglenatide, which is customized for Korean patients. Its launch is expected to set the stage for intensifying competition between domestic and global therapies.