NCT06449833

Effect of Henagliflozein on Hepatic Fat Content in Patients With T2DM and NAFLD

Effect of Henagliflozein on Hepatic Fat Content in Patients With Type 2 Diabetes Mellitus and Nonalcoholic Fatty Liver Disease: A Multicenter, Randomized, Controlled Clinical Trial

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Zhujiang Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study focuses on the effects of Henagliflozein on hepatic fat content in patients with type 2 diabetes mellitus (DM) and nonalcoholic fatty liver disease (NAFLD). Sponsored by Zhujiang Hospital of Southern Medical University, this study is a multi-center, randomized, controlled clinical trial, aiming at exploring the difference in the reduction of liver fat content in the subjects compared with the control group after 24 weeks of treatment. Subjects from different medical centers diagnosed with T2DM and NAFLD will be randomly assigned to the treatment or control group in a 1:1 ratio, and subsequently initiate the intervention period of 24 weeks. In this trial, patients will be treated with 10 mg of Henagliflozein + metformin and 5 mg of Linagliptin + metformin as control, and the dose of metformin will be customized at 500-1500mg according to their individual blood glucose level. The check-points are set at the 8th, 16th and 24th week of the follow-up after the treatment, and nutritionists are available to provide dietary and exercise guidance.

Conditions

• Type2 Diabetes Mellitus
• Nonalcoholic Fatty Liver Disease

Interventions

Type	Name	Description
DRUG	Henagliflozein and Metformin	The experimental group will be treated with 10mg Henagliflozein and Metformin.
DRUG	Linagliptin and Metformin	The control group will be treated with 5mg Linagliptin and Metformin.

Timeline

• Start date: 2024-06-01
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2024-06-10
• Last updated: 2024-06-10

Locations

1 site across 1 country: China