An interventional study of GODEX® capsule treatment group in Hepatic Steatosis, Fatty Liver and Non-Alcoholic Fatty Liver Disease, sponsored by Samsung Medical Center. Not yet recruiting. Open to participants aged 19 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Samsung Medical Center · Not applicable, Interventional, and Treatment
Living donor liver transplantation (LDLT) is a critical therapeutic modality for patients with end-stage liver disease and hepatic malignancies. However, the donor's surgical safety is paramount, and the presence of hepatic steatosis frequently precludes potential donors from qualifying for donation due to risks for both donor and recipient. With the rising prevalence of fatty liver disease, an increasing number of candidate donors are excluded during screening, complicating timely transplantation for urgent recipients.
This study aims to evaluate whether the administration of a carnitine complex (GODEX®) can improve hepatic steatosis within 3 months, as assessed by liver computed tomography (CT), in potential living liver donors. In addition, the study will investigate the living liver donation rate within 3 months, post-enrollment donor liver function at 36 weeks, weight and BMI reduction, and improvements in associated metabolic comorbidities (hypertension, diabetes mellitus, and dyslipidemia).
Secondary Objectives To determine the living liver donation rate within 3 months of carnitine complex administration.
To assess liver function at 36 weeks post-enrollment in living liver donors who received the carnitine complex.
To evaluate the reduction in body weight and body mass index (BMI), as well as the improvement of accompanying comorbidities (hypertension, diabetes mellitus, and dyslipidemia).
The surgical safety of the living liver donor must be prioritized above all else. However, the presence of hepatic steatosis often precludes donation due to safety concerns for both the donor and the recipient. Recently, the prevalence of fatty liver disease has been increasing in South Korea, leading to an increase in potential donors being deemed ineligible during screening. Consequently, determining the optimal timing for liver transplantation in patients requiring urgent care has become increasingly challenging.
GODEX®, a carnitine complex, is an established hepatotherapeutic agent proven effective in reducing elevated liver enzymes in liver disease and improving hepatic steatosis in diabetic patients with nonalcoholic fatty liver disease (NAFLD). This study aims to investigate whether the administration of carnitine complex can improve hepatic steatosis in living liver donors and facilitate successful partial liver donation.
1,617 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 324 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 1,176 interventional studies indexed under Non-alcoholic Fatty Liver Disease.
Browse Non-alcoholic Fatty Liver Disease studies →Samsung Medical Center is the lead sponsor of 1,011 studies on the registry; 152 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Compared within Non-alcoholic Fatty Liver Disease, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Fatty Liver. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will orally take GODEX® capsules (composed of carnitine orotate and six other active ingredients) at a dose of two capsules three times daily for up to 12 months following study enrollment.
Drug: GODEX® capsule treatment group
Subjects will orally take GODEX® capsules (composed of carnitine orotate and six other active ingredients) at a dose of two capsules three times daily for up to 12 months following study enrollment.
Percentage of Participants With Liver-to-spleen Attenuation Difference Greater Than 10 Hounsfield Units (HU) or Absolute Liver Attenuation Greater Than 40 HU on Liver Computed Tomography (CT)
Non-contrast liver computed tomography (CT) was performed to assess hepatic steatosis (fatty liver). Tissue radiodensity was measured in Hounsfield Units (HU) in the liver and spleen. The data represent the percentage of participants who achieved a liver-to-spleen attenuation difference greater than 10 HU or an absolute liver attenuation greater than 40 HU, indicating significant reduction or resolution of liver fat. Higher percentages represent better outcomes.
Time frame: Baseline (Preoperative)
Change From Baseline in Serum Concentrations of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), and Gamma-Glutamyl Transferase (GGT)
Serum concentrations of liver enzymes-aspartate aminotransferase (AST), alanine aminotransferase (ALT), and gamma-glutamyl transferase (GGT)-were measured via standard venous blood sampling (liver function test) and reported in units per liter (U/L). Elevated levels of these enzymes typically indicate liver inflammation or hepatocellular injury. Data represent the change from baseline (post-treatment value minus baseline value) at the designated time point. A greater negative change (reduction in enzyme levels) reflects an improvement in liver function.
Time frame: Baseline and 36 weeks
Change From Baseline in Controlled Attenuation Parameter (CAP) and Liver Stiffness Measurement (LSM) Assessed by Transient Elastography (FibroScan)
Transient elastography (FibroScan) is a non-invasive ultrasound examination evaluating hepatic steatosis (fatty liver) and fibrosis (scarring). Controlled Attenuation Parameter (CAP), measured in dB/m, quantifies liver fat. Liver Stiffness Measurement (LSM), measured in kPa, assesses tissue stiffness. Data represent the change from baseline (post-treatment minus baseline). Negative changes in both scores indicate reductions in liver fat and stiffness, representing improved liver outcomes.
Time frame: Baseline and 36 weeks
Percentage of Participants Who Successfully Underwent Living Donor Liver Transplantation (LDLT)
Living donor liver transplantation (LDLT) is a surgical procedure in which a healthy individual donates a portion of their liver to a recipient with liver disease. Candidates with hepatic steatosis (fatty liver) typically undergo medical evaluation and intervention to reduce liver fat to safe levels prior to donation. This outcome measure evaluates whether participating potential donors successfully proceeded to the surgical donation following protocol completion. The data represent the percentage of enrolled participants who completed living liver donation, confirmed via medical and surgical records at the study endpoint. Higher percentages reflect higher donor eligibility and successful procedure rates.
Time frame: Baseline and 12 weeks
Time to Living Liver Donation From Study Enrollment
Time to living liver donation was defined as the duration (in days) from the date of study enrollment to the date of the donor hepatectomy surgery for living donor liver transplantation (LDLT). The exact surgical date was confirmed through hospital electronic medical records. For participants who did not proceed to donation due to withdrawal, ineligibility, or study completion without surgery, data were censored at the date of the last follow-up visit. The reported data represent the median time required for potential donors to achieve eligibility and undergo the donation procedure, where shorter durations reflect more rapid donor readiness.
Time frame: Baseline and 12 weeks
Percentage of Participants With at Least a 10 Percent Reduction in Body Weight and Body Mass Index (BMI)
Body weight was measured in kilograms using a standardized calibrated digital scale, and body mass index (BMI) was calculated as body weight in kilograms divided by the square of height in meters (kg/m²). Percentage reduction from baseline was calculated as: \[(Baseline Value - Post-treatment Value) / Baseline Value\] × 100. A reduction of at least 10% in body weight typically corresponds to an equivalent percentage reduction in BMI. The reported data represent the percentage of participants who achieved a reduction of 10% or greater from baseline at the designated evaluation time point. Higher percentages indicate a greater proportion of participants achieving clinically significant weight and BMI reduction.
Time frame: Baseline and 36 weeks
Change From Baseline in Body Weight and Body Mass Index (BMI)
Body weight was measured in kilograms (kg) using a calibrated digital scale, and body mass index (BMI) was calculated as weight in kilograms divided by the square of height in meters (kg/m²). Data represent the change from baseline (post-treatment value minus baseline value) at the designated evaluation time point. A negative change reflects a reduction in body weight and BMI, indicating successful weight loss.
Time frame: Baseline and 36 weeks
Change From Baseline in Fibrosis-4 (FIB-4) Index Scores
The Fibrosis-4 (FIB-4) index is a non-invasive scoring system used to estimate the risk of liver fibrosis (scarring). The score is calculated using standard clinical parameters. Data represent the change from baseline (post-treatment score minus baseline score) at the designated evaluation time point. Lower scores reflect a lower probability of advanced fibrosis, and a negative change from baseline indicates an improvement in liver fibrosis status.
Time frame: Baseline and 36 weeks
Number of Participants With Improvement in Comorbidities: Hypertension, Diabetes Mellitus, and Dyslipidemia
Comorbid conditions-hypertension (high blood pressure), diabetes mellitus (elevated blood glucose), and dyslipidemia (abnormal blood lipid levels)-were assessed at baseline and the designated follow-up visit using standardized blood pressure measurements, fasting blood glucose or glycated hemoglobin (HbA1c) levels, and serum lipid panels. Improvement was defined as achieving clinically recommended target ranges (e.g., blood pressure \<130/80 mmHg, HbA1c \<6.5%, or normalized lipid profiles) or a documented reduction or discontinuation in related prescription medications without disease worsening. The reported data represent the number of participants who demonstrated improvement in one or more of these baseline comorbidities. Higher numbers reflect more favorable cardiometabolic health outcomes.
Time frame: Baseline and 36 weeks
Number of Participants and Incidence of Adverse Events (AEs) Stratified by Severity, Causality, and System Organ Class (SOC) Using the Medical Dictionary for Regulatory Activities (MedDRA)
An adverse event (AE) is defined as any untoward medical occurrence in a participant, regardless of whether it is considered related to the study intervention. AEs were monitored through participant self-reports, physical examinations, and clinical laboratory evaluations throughout the study period. All reported events were coded using the Medical Dictionary for Regulatory Activities (MedDRA) and classified by System Organ Class (SOC) and Preferred Term (PT). Each event was assessed for severity (mild, moderate, or severe), causality (related or not related to the study intervention), actions taken (e.g., dose modification or discontinuation), and clinical outcome (e.g., resolved or persistent). Reported data include the total number of events, the number of participants experiencing at least one event, and the corresponding percentages within each category. Lower incidences reflect a more favorable safety profile.
Time frame: Through study completion, an average of 36 weeks
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Non-alcoholic Fatty Liver Disease →