NCT06218342

Henagliflozin in Relieving Type 2 Diabetes With Non-alcoholic Fatty Liver Disease

The Study of Henagliflozin in Relieving Progression of Type 2 Diabetes With Non-alcoholic Fatty Liver Disease

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 156 (estimated)
• Sponsor: Sir Run Run Shaw Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is a randomized, non-blinded clinical trial specifically designed to assess the initial feasibility and efficacy of SGLT2 inhibitors in treating NAFLD among adults diagnosed with type 2 diabetes.

Detailed description

Non-alcoholic fatty liver disease (NAFLD) is a metabolic liver disease that encompasses a spectrum of progressive pathological changes, ranging from simple steatosis to non-alcoholic steatohepatitis (NASH), cirrhosis, and hepatocellular carcinoma (HCC). Epidemiological data demonstrate a close association between type 2 diabetes and NAFLD. Approximately 49% to 62% of individuals with type 2 diabetes have concurrent NAFLD, and those with NAFLD have a risk of developing diabetes more than twice that of the general population. NAFLD not only increases the risk of developing type 2 diabetes but also accelerates the progression of diabetes-related target organ damage, leading to adverse metabolic and cardiovascular risks. Currently, there is a global lack of comprehensive public health strategies for addressing NAFLD, and clinically, there are still no approved drugs specifically for treating NAFLD. NAFLD is diagnosed through abnormal liver function test results and imaging examinations. The NAFLD Fibrosis Score (NFS) and Fibrosis-4 (FIB-4) Index can be used for clinical screening of NASH in individuals with type 2 diabetes. Ultrasound attenuation parameters (UAP) and liver stiffness measurements (LSM) based on transient elastography (TE) can accurately differentiate between liver steatosis and the degree of liver fibrosis. This technique, known for its non-invasive, safe, and reproducible nature, has found widespread application in diagnosing the extent of liver fat and fibrosis in patients with chronic liver diseases. The primary approach to treating NAFLD involves modifying poor lifestyle habits, however, lifestyle changes are often difficult to sustain in the long term. Currently, neither the U.S. FDA nor the European Medicines Agency has approved any medications specifically for NAFLD treatment. Given the central role of insulin resistance in the development of NAFLD, hypoglycemic medications have become a new focus in the prevention and treatment of NAFLD. Sodium-glucose co-transporter-2 (SGLT-2) inhibitors, by inhibiting SGLT-2 activity, reduce the reabsorption of glucose in the proximal renal tubules, causing excess glucose to be excreted in the urine, thereby lowering blood sugar. Reports suggest that SGLT-2 inhibitors also have several other beneficial effects, including reducing the risk of cardiovascular and kidney diseases, improving blood pressure control, aiding weight reduction, and lowering liver fat content. Previous studies have shown that SGLT-2 inhibitors can improve alanine transaminase, aspartate transaminase, gamma-glutamyl transferase, and the FIB-4 Index in patients with type 2 diabetes complicated by NAFLD, potentially exhibiting anti-fibrotic effects on the liver. Henagliflozin, the SGLT-2 inhibitor used in this study, is a compound independently developed with intellectual property by Jiangsu Hengrui Medicine Co., Ltd. Henagliflozin has demonstrated efficacy and safety in monotherapy for inadequately controlled type 2 diabetes patients with poor diet and exercise control or in combination with metformin for inadequately controlled type 2 diabetes patients. This study aims to observe the clinical efficacy of henagliflozin treatment for type 2 diabetes complicated by NAFLD in individuals, evaluating its potential to improve liver fat changes and fibrosis indicators in NAFLD, promoting NASH regression, and alleviating the progression of liver fibrosis, building upon lifestyle changes and basic treatments. The secondary objectives include investigating the effects of henagliflozin on liver fat content, visceral fat area, liver enzymes, and blood sugar improvement.

Conditions

• Type 2 Diabetes
• Non-Alcoholic Fatty Liver Disease

Interventions

Type	Name	Description
DRUG	Henagliflozin	Besides lifestyle intervention and background medication, participants will be prescribed Henagliflozin at standard clinical doses.
OTHER	Background medication	Participants will only receive lifestyle intervention and background medication.

Timeline

• Start date: 2024-02-15
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2024-01-23
• Last updated: 2024-01-23