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Clinical Trial Assessing Godex Carnitine Orotate Complex in Nonalcoholic Fatty Liver Disease Patients for Efficacy

Non-Alcoholic Fatty Liver Disease Clinical Trial

Official title:
A Randomized, Double-blind, Placebo-controlled, Multicenter, Prospective Comparative, Investigator-initiated Clinical Trial to Evaluate the Efficacy of Carnitine Orotate Complex _Godex® in Patients With Nonalcoholic Fatty Liver Disease

Clinical Trial Summary

the purpose of this clinical trial is to assess the efficacy and safety of Orotic Acid Carnitine Complex Capsules (Godex®) in comparison to a placebo control group in patients with Non-Alcoholic Fatty Liver Disease (NAFLD).

Clinical Trial Description

the purpose of this clinical trial is to assess the efficacy and safety of Orotic Acid Carnitine Complex Capsules (Godex®) in comparison to a placebo control group in patients with Non-Alcoholic Fatty Liver Disease (NAFLD). Godex® is being investigated for its potential to contribute to a reduction in liver fat content and improvement in liver fibrosis when administered over an extended period in patients with NAFLD. Additionally, this study aims to confirm the normalization of HbA1c and ALT, as observed in previous research, and to verify the reduction in intrahepatic fat content through MRI-PDFF analysis and improvement in liver fibrosis via MRE assessment. This investigation is motivated by the insufficient preliminary research on the long-term prescription of Godex® for NAFLD. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06152991
Study type Interventional
Source Seoul National University Hospital
Contact
Status Enrolling by invitation
Phase Phase 3
Start date September 25, 2023
Completion date February 26, 2027
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