Daewoong Pharmaceutical Enblo Achieves 88% Target Enrollment in Direct Comparative SGLT-2 Inhibitor Clinical Trial

ENVELOP Study Progresses Smoothly with 2,862 Participants
Non-Inferiority Assessment Against Dapagliflozin and Empagliflozin

Daewoong Pharmaceutical announced on June 4 that the comparative clinical study "ENVELOP" for its diabetes medication Enblo (ingredient: inavogliflozin) has achieved an 88% target patient enrollment rate.

The Korean Diabetes Association is announcing the integrated cardiovascular, kidney, and metabolic (CKM) management efficacy and stable interim analysis results of "Enblo" through the Asia-specific "ENVELOP" study. Daewoong Pharmaceutical

The ENVELOP study is a multicenter study led by Professor Kim Shingon’s research team in the Department of Endocrinology at Korea University College of Medicine. The efficacy of Enblo in cardiovascular, kidney, and metabolic (CKM) management is being directly compared with the existing SGLT-2 inhibitors dapagliflozin and empagliflozin.

This study was designed as a pragmatic clinical trial that reflects real-world clinical settings. Fifty-five medical institutions in Korea are participating, with the goal of securing real-world evidence (RWE) for Asian patients.

According to Daewoong Pharmaceutical, as of April this year, approximately 88% of the target 2,862 participants had been enrolled. The average age of registered patients was 60.4 years, and their average body mass index (BMI) was 26.26 kg/m².

Interim analysis showed no significant difference between the test and control groups in key indicators such as glycated hemoglobin (HbA1c), estimated glomerular filtration rate (eGFR), and urine albumin-to-creatinine ratio (UACR). No serious adverse drug reactions (SADR) were reported. The results of the study were released at the Spring Scientific Conference of the Korean Diabetes Association, which was held at the Kim Daejung Convention Center in Gwangju from April 30 to May 2.

Professor Kim Shingon of the Department of Endocrinology at Korea University College of Medicine said, "Through this study, we will be able to secure long-term clinical evidence for Asian patients."

Park Hyungchul, Head of ETC Marketing at Daewoong Pharmaceutical, stated, "We are securing clinical evidence for Enblo through the world’s first head-to-head study among SGLT-2 inhibitors," adding, "We will continue to accumulate data that will help inform future treatment decisions."

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