drugset / Trial / NCT06762223

Henagliflozin on Liver Fibrosis in Patients with MASLD and T2DM

NCT06762223

Phase 4 Not yet recruiting 190 enrolled Xiqiao Zhou Jiangsu Hengrui Pharmaceutical Co., Ltd. · collab
RandomizedParallel-groupTriple-blindTreatment

Summary

The prevalence of metabolic dysfunction-associated steatotic liver disease (MASLD) is increasing due to changes in economic conditions and lifestyle, and it is anticipated to become a significant liver disease burden in the future. This is particularly true for patients with MASLD who also have type 2 diabetes mellitus (T2DM), as the rate of comorbidity between these conditions has risen in recent years due to their shared mechanisms, necessitating careful management of both. Liver fibrosis is a critical concern, as poor blood glucose control can worsen liver fibrosis, which in turn complicates blood sugar management. Therefore, addressing liver fibrosis in patients with MASLD and T2DM is urgent, yet there are currently no targeted therapies to reverse its progression. SGLT2 inhibitors, have shown promise in potentially reversing liver fibrosis, but existing research is limited and has not adequately focused on liver fibrosis improvement, highlighting the need for more robust evidence-based studies.

Timeline

Start
2024-12-31
Primary completion
2026-12-31
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Henagliflozin Small molecule 10 mg
Background Metformin Small molecule 1700 mg