Logo 1 Logo 2

Clinical Trial Details

Trial ID: L5303
Source ID: NCT06218342
Associated Drug: Henagliflozin
Title: Henagliflozin in Relieving Type 2 Diabetes With Non-alcoholic Fatty Liver Disease
Acronym:
Status: NOT_YET_RECRUITING
Study Results: NO
Results:
Conditions: Type 2 Diabetes|Non-Alcoholic Fatty Liver Disease
Interventions: DRUG: Henagliflozin|OTHER: Background medication
Outcome Measures: Primary: Ultrasound attenuation parameter (UAP), Changes in ultrasound attenuation parameter (UAP) from baseline. Higher UAP correlates with increased severity of steatosis., 24 weeks|Liver stiffness measurement (LSM), Changes in liver stiffness measurement (LSM) from baseline. Higher LSM values correlate with advancement in the stage of liver fibrosis., 24 weeks | Secondary: Non-Alcoholic Fatty Liver Disease Fibrosis Score (NFS), Changes in Non-Alcoholic Fatty Liver Disease Fibrosis Score (NFS) from baseline. Higher NFS score suggests advanced liver fibrosis., 24 weeks|Fibrosis Index Based on 4 Factors (FIB-4 Index), Changes in FIB-4 Index from baseline. Higher FIB-4 Index correlates with increased severity of hepatic fibrosis., 24 weeks|Liver fat content, Changes in liver fat content from baseline, 24 weeks|Liver enzymes, Changes in liver enzymes from baseline, the enzymes include ALP (alkaline phosphatase), ALT (alanine transaminase), AST (aspartate aminotransferase), and GGT (gamma-glutamyl transferase)., 24 weeks|Cholestatic proteins (Chitinase 3-like protein 1, CHI3L1), Changes in CHI3L1 from baseline. Higher CHI3L1 level suggests advanced liver fibrosis., 24 weeks|Intrabdominal fat, Changes in visceral fat area from baseline, 24 weeks|Glucose level, Changes in HbA1c from baseline, 24 weeks|Body weight, Changes in body weight from baseline, 24 weeks
Sponsor/Collaborators: Sponsor: Sir Run Run Shaw Hospital
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 156
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-02-15
Completion Date: 2025-12-31
Results First Posted:
Last Update Posted: 2024-01-23
Locations:
URL: https://clinicaltrials.gov/show/NCT06218342