NCT06152991

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

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

• Status: Enrolling By Invitation
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 196 (estimated)
• Sponsor: Yoon Jun Kim · Academic / Other
• Sex: All
• Age: 19 Years – 74 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Non-Alcoholic Fatty Liver Disease

Interventions

Type	Name	Description
DRUG	GODEX	The amount of active ingredient per dose (1 capsule) * Carnitine Orotate 150mg * liver extract antitoxic fraction 12.5㎎ * Adenine Hydrochloride 2.5mg * Pyridoxine Hydrochloride 25mg * Riboflavin 0.5mg * Cyanocobalamin 0.125mg * Biphenyl Dimethyl Dicarboxylate 25mg
DRUG	Placebo	* Anhydrous lactose 50mg. * Colloidal silicon dioxide 12mg. * Amorphous cellulose 50mg. * Lactose monohydrate 215.625mg. * Magnesium stearate 7mg. * Upper and lower brown opaque capsules 77mg.

Timeline

• Start date: 2023-09-25
• Primary completion: 2026-06-30
• Completion: 2027-02-26
• First posted: 2023-12-01
• Last updated: 2023-12-01

Locations

1 site across 1 country: South Korea