Clinical Trial Assessing Godex Carnitine Orotate Complex... | NCT06152991

NCT06152991

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Celltrion Pharm, Inc.	INDUSTRY

Description Module

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Changes in hepatic fibrosis measured by MRE at 96 weeks compared to baseline.	Present the mean and standard deviation [or median and IQR (Inter Quartile Range), if necessary] along with a 95% confidence interval for the intrahepatic fat measured by MRI-PDFF at baseline and the change from baseline to week 48 for each group. The comparison of intrahepatic fat at baseline and the change in intrahepatic fat at week 48 between the two groups will be assessed using two sample t-test or Wilcoxon's rank sum test, depending on the normality of the data.

Other Outcomes

Measure	Description	Time Frame
Adverse events	- The summary and analysis of adverse events are conducted for treatment-emergent adverse events (TEAEs) occurring after the administration of investigational medicinal products in the clinical trial. The frequency and percentage of adverse events, adverse drug reactions (ADRs), and serious adverse events (SAEs) occurring after the administration of investigational medicinal products are presented by treatment group. These occurrences are compared using Pearson's chi-square test or Fisher's exact test

Eligibility Module

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.

ID	Term
D005234	Fatty Liver
D008107	Liver Diseases
D004066	Digestive System Diseases