Envlo (ingredient name: enavogliflozin), a homegrown diabetes drug developed by Daewoong Pharmaceutical (069620.KS), has demonstrated its potential to improve fatty liver in addition to controlling blood sugar. The findings are raising expectations that the drug could evolve into a "multi-player" treatment covering metabolic diseases such as fatty liver beyond diabetes.
Daewoong Pharmaceutical said on the 9th that a study confirming the potential of Envlo, an SGLT-2 inhibitor-class diabetes drug, to improve hepatic steatosis was published in the SCI-level international journal Diabetes, Obesity and Metabolism (DOM).
The study evaluated Envlo's effect on metabolic dysfunction-associated steatotic liver disease (MASLD), a condition commonly accompanying diabetes. As the prevalence of MASLD among type 2 diabetes patients has recently increased, treatments that address not only blood sugar control but also improvement in liver metabolism are becoming increasingly important. MASLD is a disease in which fat accumulates excessively in the liver due to impaired metabolic function. It commonly accompanies type 2 diabetes, and if left untreated, it is known to be highly dangerous as it can lead to liver disease and cardiovascular disease.
The researchers integrated all three clinical trial datasets used for Envlo's marketing approval, analyzing treatment effects over 24 weeks in 587 patients with type 2 diabetes. Fatty liver levels were measured using the Hepatic Steatosis Index (HSI) and the Framingham Steatosis Index (FSI). The two indicators assess how much fat has accumulated in the liver by combining measures such as a patient's blood sugar, blood pressure, and liver function values. At the start of the study, about half of all patients had fatty liver.
The analysis showed that a higher proportion of patients in the Envlo group saw their fatty liver levels decrease compared with the placebo group (p<0.001). Among the 75 study subjects, the number of fatty liver patients by HSI criteria fell from 36 (48.0%) to 12 (16.0%), meaning about 67% of the original fatty liver patients recovered to normal levels. By the FSI measure, the at-risk group also decreased from 31 patients (41.3%) to 12 (16.0%), with about 61% of at-risk patients improving to the normal range.
A comparative study with dapagliflozin, a treatment in the same class, was also conducted (p=0.0257). The results showed that the Envlo group improved fatty liver levels more than the dapagliflozin group. The change in HSI was -4.51 for the Envlo group, larger than that of the dapagliflozin group (-3.49). Notably, the Envlo group's score dropped by an additional 1.02 points, bringing the steatosis index into the normal range.
The company said the study is highly significant as the first to confirm that Envlo can improve fatty liver indicators in patients with type 2 diabetes. In particular, a post-hoc analysis of existing clinical data demonstrated Envlo's potential to improve liver metabolism. The drug also showed statistically significant improvement in some fatty liver indicators compared with dapagliflozin, a drug in the same class. This is expected to serve as a foundation for follow-up research to further verify Envlo's direct effects on reducing liver fat and improving liver fibrosis through imaging-based assessments or long-term follow-up studies.
"This study is meaningful in that it confirmed for the first time that Envlo may have a positive effect not only on blood sugar control but also on reducing fat accumulation in the liver in patients with type 2 diabetes," said Jeong In-kyung, a professor of endocrinology at Kyung Hee University Hospital at Gangdong and the corresponding author of the paper. "In particular, as it showed superior improvement effects in some fatty liver indicators compared with drugs in the same class, we can further anticipate Envlo's role in future treatment strategies for patients with metabolic dysfunction-associated steatotic liver disease," said Jung Chang-hee, a professor of endocrinology at Asan Medical Center and co-corresponding author.
"These research results show that Envlo can provide additional therapeutic benefits beyond blood sugar control, namely the improvement of fatty liver indicators," said Park Hyung-chul, head of the ETC Marketing Division at Daewoong Pharmaceutical. "As metabolic dysfunction-associated steatotic liver disease has a high comorbidity rate of about 65% or more among type 2 diabetes patients, this can serve as evidence supporting the potential expansion of Envlo's therapeutic value in real-world clinical settings."
