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

NCT06152991 | Enrolling By Invitation Phase 3 DMC

• 1 other identifier: UMTGODEX_001
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

NAFLD; Non-Alcoholic Fatty Liver Diease; GODEX

Outcome Measures

Primary Outcomes (1)

• Change in intrahepatic fat content measured by MRI-PDFF

  For each group, the mean and standard deviation \[if necessary, median and interquartile range (IQR)\] along with a 95% confidence interval are provided for the liver fat content measured by MRI-PDFF at baseline and the change from baseline to the 48-week time point. The difference in liver fat content at baseline and the change in liver fat content at the 48-week time point between the two groups are tested using the two-sample t-test or Wilcoxon's rank sum test, depending on the normality of the data.

  48-week time point compared to baseline.

Secondary Outcomes (15)

• Changes in hepatic fibrosis measured by MRE at 96 weeks compared to baseline.

  96-week time point compared to baseline.

• Changes in hepatic fat content measured by MRI-PDFF at 96 weeks compared to baseline.

  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.

  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.

  48-week and 96-week time points compared to baseline.

• Changes in CAP measured by Fibroscan at 48 and 96 weeks compared to baseline.

  96-week time point compared to baseline.

Other Outcomes (3)

• Adverse events

  immediately after the intervention

• Proportion of subjects with abnormal Laboratory Tests

  immediately after the intervention

• Proportion of subjects with abnormal vital signs

  immediately after the intervention

Study Arms (2)

Test Group

EXPERIMENTAL

Oral administration of 2 capsules of Godex® three times a day (tid) for 96 weeks

Drug: GODEX

Control Group

PLACEBO COMPARATOR

Oral administration of 2 placebo capsules three times a day (tid) for 96 weeks

Drug: Placebo

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

Test Group

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.

Control Group

Eligibility Criteria

• Age: 19 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yoon Jun Kim: lead
• Celltrion Pharm, Inc.: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• YoonJun Kim, MD.PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This clinical trial will be conducted as a double-blind study. The double-blind condition ensures that the investigational drug and the placebo are manufactured to be indistinguishable in terms of appearance, with identical formulations and characteristics, and are supplied in identical packaging. All investigational drugs for the clinical trial will be managed using unique code numbers.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Coordinating Investigator

Model Details: Double-Blindle

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: December 1, 2023
• Study Start: September 25, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): February 26, 2027
• Last Updated: December 1, 2023

Record last verified: 2023-11

Locations

KR (1)