Envlo accumulates evidence in Asia through H2H SGLT-2 trial

ENVELOP reaches 88% enrollment target... Direct comparison with dapagliflozin and empagliflozin

Daewoong Pharmaceutica, "Will secure evidence for integrated CKM management based on real-world clinical practice."

Presentation at the Korean Diabetes Association Spring Scientific Meeting.

Daewoong Pharmaceutical is accelerating efforts to accumulate real-world clinical evidence in Asian patients through a direct head-to-head clinical trial of its domestically developed diabetes drug Envlo (enavogliflozin) against other SGLT-2 inhibitors.

The company announced on June 4 that it presented interim analysis results and the latest progress of the ENVELOP study at the 39th Korean Diabetes Association Spring Scientific Meeting, held from April 30 to May 2 at the Kimdaejin Convention Center in Gwangju.

The ENVELOP study is a large-scale investigation led by Professor Sin Gon Kim of Korea University College of Medicine, with participation from a nationwide multicenter research network. The study was designed to evaluate whether Envlo, Korea's 36th domestically developed new drug, can generate clinical evidence supporting cardiovascular disease prevention and kidney function improvement in Asian patients with diabetes in real-world practice.

In diabetes treatment, SGLT-2 inhibitors have expanded their role beyond glycemic control, based on their cardiovascular and renal protective benefits. As cardiovascular death and declining kidney function are major determinants of prognosis in patients with diabetes, integrated management of cardiovascular-kidney-metabolic (CKM) health has become increasingly important.

Daewoong noted that while large global Cardiovascular Outcome Trials (CVOTs) have established the cardiovascular and renal benefits of the SGLT-2 inhibitor class, most were placebo-controlled studies. Consequently, evidence directly comparing agents within the class has remained limited, making treatment selection in actual clinical practice challenging.

The ENVELOP was specifically designed to address this evidence gap. According to Daewoong, the trial directly compares Envlo with two SGLT-2 inhibitors—dapagliflozin and empagliflozin—with a primary objective of demonstrating non-inferiority.

Importantly, the study employs a pragmatic clinical trial design, reflecting data generated in real-world clinical practice rather than a strictly controlled experimental environment. Conducted as a multicenter, prospective study involving endocrinologists from 55 institutions across Korea, it is expected to provide clinically meaningful evidence specific to Asian populations, including Korean patients, unlike existing global clinical data accumulated primarily around Western populations.

The study is progressing smoothly. As of April 2026, approximately 88% of the target enrollment of 2,862 patients have been enrolled. The average age of the enrolled patients was 60.4 years, and the average body mass index (BMI) was 26.26 kg/m².

Interim analysis showed no statistically significant differences versus comparator groups in key endpoints, including hemoglobin A1c (HbA1c), estimated glomerular filtration rate (eGFR), and urine albumin-creatinine ratio (UACR).

Daewoong Pharmaceutical noted how this study was conducted based on an Asian patient population with an average BMI of approximately 26 kg/m². This is because it can reflect the characteristics of Korean and Asian patients, who have different profiles in terms of cardiovascular risk structures and renal disease prevalence compared to existing Western-centered global clinical trials. The company expects the findings to serve as important academic and clinical evidence for prescribing decisions throughout Asia.

Professor Sin Gon Kim of Korea University College of Medicine said, "Although GLP-1 therapies have recently attracted significant attention, SGLT-2 inhibitors continue to demonstrate unique advantages in terms of proven cardiovascular and renal protection as well as cost-effectiveness. Through this study, we hope to generate long-term evidence for Asian patients and further elevate the global standing of Korean medicine."

Hyung Chul Park, Head of ETC Marketing at Daewoong Pharmaceutical, stated, "The ENVELOP study holds particular significance as it generates differentiated clinical evidence for Envlo based on real-world clinical practice data. As the world's first direct comparison among SGLT-2 inhibitors, it has the potential to become an important academic asset that could influence treatment-selection criteria in Korea."

He added, "We will continue strengthening data-driven marketing efforts in Korea and abroad while generating Korean-specific clinical evidence to provide optimal treatment options for patients with diabetes.”

The study was unveiled at the 39th Spring Scientific Meeting of the Korean Diabetes Association, which was held under the theme ‘Challenges and Innovations for Overcoming Diabetes.’ During the event, a total of 63 sessions were held, featuring presentations by 213 domestic and international experts and 106 poster presentations