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

NCT06152991 · Status: ENROLLING_BY_INVITATION · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2023-12-01

No results posted yet for this study

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).

Conditions

  • Non-Alcoholic Fatty Liver Disease

Interventions

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.

Sponsors & Collaborators

  • Celltrion Pharm, Inc.

    collaborator INDUSTRY

  • Yoon Jun Kim

    lead OTHER

Principal Investigators

  • YoonJun Kim, MD.PhD · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-25
Primary Completion
2026-06-30
Completion
2027-02-26

Countries

  • South Korea

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06152991 on ClinicalTrials.gov