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

Sponsor
Yoon Jun Kim
Study ID
NCT06152991
Phase
PHASE3
Status
Enrolling By Invitation

Conditions

  • Non-Alcoholic Fatty Liver Disease

Eligibility Criteria

Sex
ALL
Age
19 Years - 74 Years
Healthy Volunteers
Not accepted

Interventions

  • GODEX — DRUG
    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
  • Placebo — DRUG
    * Anhydrous lactose 50mg. * Colloidal silicon dioxide 12mg. * Amorphous cellulose 50mg. * Lactose monohydrate 215.625mg. * Magnesium stearate 7mg. * Upper and lower brown opaque capsules 77mg.

Study Details

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).

Key Dates

First listed
Dec 1, 2023
Start date
Sep 25, 2023
Status verified
Nov 2023
Primary completion
Jun 30, 2026
Completion
Feb 26, 2027

Study Design

Enrollment
196 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Test Group
    Oral administration of 2 capsules of Godex® three times a day (tid) for 96 weeks
  • Placebo Comparator: Control Group
    Oral administration of 2 placebo capsules three times a day (tid) for 96 weeks

Primary Outcome Measure

Change in intrahepatic fat content measured by MRI-PDFF [ Time Frame: 48-week time point compared to baseline. ]

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