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

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

Overview

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.

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.

Primary outcome measures

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

Secondary outcome measures (12)

• Changes in hepatic fibrosis measured by MRE at 96 weeks compared to baseline. [Time frame: 96-week time point compared to baseline.]
• Changes in hepatic fat content measured by MRI-PDFF at 96 weeks compared to baseline. [Time frame: 96-week time point compared to baseline.]
• Proportion of subjects with a reduction in hepatic fat content measured by MRI-PDFF at 48 and 96 weeks of 20% or more compared to baseline. [Time frame: 96-week time point compared to baseline.]
• Proportion of subjects with an improvement in hepatic fibrosis measured by MRE at 96 weeks of 20% or more compared to baseline. [Time frame: 48-week and 96-week time points compared to baseline.]
• Changes in CAP measured by Fibroscan at 48 and 96 weeks compared to baseline. [Time frame: 96-week time point compared to baseline.]
• Changes in LSM measured by Fibroscan at 48 and 96 weeks compared to baseline. [Time frame: 96-week time point compared to baseline.]
• Changes in body weight at 48 and 96 weeks compared to baseline. [Time frame: 48-week and 96-week time points compared to baseline.]
• Changes in waist circumference at 48 and 96 weeks compared to baseline. [Time frame: 48-week and 96-week time points compared to baseline.]
• Changes in AST, ALT, r-GTP, and normalization rates at 48 and 96 weeks compared to baseline. [Time frame: 48-week and 96-week time points compared to baseline.]
• Changes in HOMA-IR ≥2.0 at 48 and 96 weeks compared to baseline [Time frame: 48-week and 96-week time points compared to baseline.]
• Changes in glycated hemoglobin (HbA1c) at 48 and 96 weeks compared to baseline [Time frame: 48-week and 96-week time points compared to baseline.]
• Changes in fasting blood glucose at 48 and 96 weeks compared to baseline [Time frame: 48-week and 96-week time points compared to baseline.]

Eligibility criteria

Inclusion criteria

• Adults aged 19 to under 75, both male and female.
• Patients with elevated liver enzymes (AST or ALT ≥ 60 or sustained AST or ALT ≥ 40 to 59 for 3 months or more).
• For diabetic patients, those with an HbA1c level of less than 8.5% and no changes in the type and dosage of antidiabetic medications in the past 12 weeks.
• Patients with an MRI-PDFF ≥ 7% indicating evidence of intrahepatic fat deposition, suspected of having non-alcoholic fatty liver disease.
• Patients who voluntarily consent to participate in this clinical trial and sign the informed consent form.

Exclusion criteria

• Individuals who have experienced a weight fluctuation of over 10% of their prior weight within the past 6 months.
• Those with AST or ALT levels exceeding 10 times the upper normal limit.
• Individuals actively involved in dieting or undergoing intense exercise therapy for weight management purposes.
• Participants with a history of surgical weight loss procedures (e.g., bariatric surgery) or those scheduled for medical or surgical interventions for weight loss during the study period.
• Individuals with endocrine disorders that may affect body weight (e.g., hypothyroidism, Cushing's syndrome) or those with TSH levels below 0.1uU/ml or above 10.0uU/ml in screening tests.
• Individuals presenting evidence of chronic hepatitis, including B or C hepatitis (For B or C hepatitis, individuals with positive HBsAg or positive HCV Ab in screening tests and positive HCV RNA are included).
• Those with a history of alcohol consumption exceeding 210 grams per week for males or 140 grams per week for females within the past year.
• Individuals who have undergone liver transplantation.
• Those undergoing renal dialysis or with creatinine levels exceeding twice the upper limit of normal.
• Individuals in a medically unstable condition to the extent that they cannot participate in the clinical trial based on physical examinations across various organ systems, encompassing cardiovascular, respiratory, gastrointestinal, hepatic-biliary, metabolic, endocrine, renal-urinary, nervous, psychiatric, and other systems.
• Individuals diagnosed with and treated for malignant tumors within the past 5 years (excluding basal cell carcinoma or squamous cell carcinoma of the skin, provided it has been determined as "cured" after surgery or treatment at the investigator's discretion).
• Pregnant or lactating women or fertile women who do not consent to using effective contraceptive methods during the study period (oral contraceptives are not considered an effective contraceptive method).
• Patients currently receiving levodopa.
• Individuals with genetic conditions such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
• Individuals with a history of significant alcohol or substance misuse within the past year.
• hose who have taken medications containing UDCA (Ursodeoxycholic acid), dimethyl-4,4'-dimethoxy-5,6,5',6'-dimethendixoybiphenyl-2,2'-dicarboxylate (DDB), or silymarin components within 4 weeks before the first dose.
• Those who have taken vitamin E (≥ 800 IU/day), received pioglitazone therapy, or used drugs approved for NASH treatment within 12 weeks before the first dose (exceptions granted if a stable dosage has been maintained for the past 24 weeks).
• Those who have taken medications affecting body weight within 12 weeks before the first dose, including obesity treatments (absorption inhibitors and appetite suppressants), antidepressants, contraceptives, oral steroids, amphetamines, phentermine, sibutramine, female hormones, thyroid hormones, etc. (exceptions granted if a stable dosage has been maintained for the past 24 weeks).
• Other individuals deemed unsuitable by the Principal Investigator
• Those who have taken investigational drugs for other clinical trials within the last 6 months.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

South Korea · 1 center

• Seoul National University Hospital — Seoul

Identifiers

NCT: NCT06152991 · UMTGODEX_001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗