Large-Scale Clinical Trial Underway… Evaluating Cardiovascular and Renal OutcomesAccording to ClinicalTrials.gov, the U.S. National Institutes of Health (NIH) clinical trial information portal, on the 18th, AstraZeneca recently registered a Phase 3 clinical trial for elecoglipron in heart failure. The trial will enroll 6,950 patients with heart failure with preserved ejection fraction (HFpEF) or heart failure with mildly reduced ejection fraction (HFmrEF).
Patients with a body mass index (BMI) of 25 kg/m² or higher, regardless of whether they have type 2 diabetes, will participate in the trial. The study will add eleogliflozin or a placebo to existing standard therapy, which includes dapagliflozin. The primary endpoint is the time to the first occurrence of a composite event consisting of cardiovascular death, hospitalization for heart failure, and emergency treatment for heart failure. The trial is scheduled to begin this month and conclude in September 2029.
Around the same time, a clinical trial involving 7,000 patients with chronic kidney disease was also registered. The study will examine whether adding eleoglifron to SGLT2 inhibitors—such as dapagliflozin—in patients receiving these medications, regardless of diabetes status, can reduce the risk of kidney disease progression and death.
The combined enrollment for the two trials is approximately 14,000 participants. This is interpreted as part of AstraZeneca’s strategy to position eleoglifron not merely as a drug for weight loss or blood glucose control, but as a treatment that addresses cardiovascular, renal, and metabolic diseases.
Elecoглифрон is a drug candidate that AstraZeneca acquired from the Chinese biotech company EcoGen in 2023. AstraZeneca secured the rights to the drug in all regions except China in exchange for an upfront payment of $185 million and milestone payments totaling up to $1.825 billion. A key feature of the drug is that it can be taken once daily without regard to food or water intake.
In a previous Phase 2 clinical trial involving obese and overweight patients, those who received the highest dose for 36 weeks experienced an average weight loss of 11.8%. In a trial involving patients with Type 2 diabetes, HbA1c levels decreased by an average of 1.9% and body weight decreased by 7.7% at Week 26.
News of Phase 3 Trials… Concerns Over Development Pace and Formulation DifferentiationThe candidate drug cited as a comparison in South Korea is Ildong Pharmaceutical’s “ID110521156.” Like eleoglifron, it is a low-molecular-weight GLP-1 receptor agonist taken once daily. Ildong Pharmaceutical has completed a Phase 1 clinical trial and is currently pursuing a global Phase 2 trial and technology transfer.
In a 4-week repeated-dose Phase 1 clinical trial of ID110521156, body weight in the high-dose group decreased by an average of 9.9%, with a maximum reduction of 13.8%. The effective plasma concentration was maintained for more than 18 hours, and no food interference or accumulation in the body was observed. The absence of serious gastrointestinal adverse events or signs of hepatotoxicity is also cited as a competitive advantage.
However, the difference in development pace is a concern. While AstraZeneca has entered a Phase 3 clinical trial involving thousands of participants, ID110521156 has only completed Phase 1.
A biotech industry official stated, “As eleoglifron advances into large-scale Phase 3 trials and cardiovascular and renal outcome trials, the standards for evaluating oral GLP-1 candidates will rise,” adding, “Latecomers will need to demonstrate competitiveness not only in initial weight loss figures but also in long-term treatment effects, gastrointestinal tolerability, and discontinuation rates to increase their chances of securing a technology transfer deal.”
Hanmi Pharmaceutical has already secured cardiovascular clinical evidence through “efpeglenatide,” a once-weekly injectable. In a global clinical trial involving 4,076 high-risk type 2 diabetes patients, efpeglenatide reduced the risk of major cardiovascular events—defined as cardiovascular death, myocardial infarction, and stroke—by 27% compared to a placebo.
However, this clinical trial focused on diabetes patients with high cardiovascular risk. The fact that the patient population differs from that of AstraZeneca’s clinical trial—which specifically recruited heart failure patients—is why it is difficult to conclude that efpeglenatide has established evidence for treatment specifically for heart failure.
The dosage forms also differ. While eleoglifron is an oral medication taken once daily, efeglenatide is a once-weekly injection. Given that oral medications—which reduce the burden of injections associated with existing obesity treatments—expand treatment accessibility and patient choice, this could create pressure for efeglenatide to address its competitive shortcomings regarding dosage form.
The company is also developing “HM101460,” an oral, small-molecule GLP-1 candidate, but it is still in the preclinical stage. Compared to the pace of eleoglifron’s development, Hanmi must either significantly narrow this development gap or pursue a differentiation strategy.
Instead, Hanmi Pharmaceutical is working to secure a competitive edge by segmenting the obesity treatment market. Through the “H.O.P. (Hanmi Obesity Pipeline)” project, which began in 2023, the company aims to build a full-cycle obesity portfolio tailored to different weight levels and metabolic characteristics.
A Hanmi Pharmaceutical official stated, “Rather than developing single drugs focused solely on weight loss, we are building patient-tailored treatment solutions that encompass quantitative and qualitative treatment of obesity, ease of administration, post-weight-loss management, and prevention.”
H.O.P consists of six pipeline candidates, including efeglenatide; “HM15275,” a triple-action GLP-1, GIP, and glucagon agonist; “HM17321,” a UCN2 analog; “HM500197,” a peptide-based myostatin inhibitor; oral and patch formulations, and digitally integrated pharmaceuticals.
