NCT07922720Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Efficacy of Carnitine-complex Supplementation on MASLD(Metabolic Dysfunction-Associated Steatotic Liver Disease) Improvement in Potential Living Liver Donors
Source: ClinicalTrials.gov · Last updated 6 Nov 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 17 Sept 2026
- Start date
- 30 Oct 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Samsung Medical Center
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT07922720
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 30 Oct 2026 to the primary completion date, 31 Dec 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for potential living liver donors aged 19 to 70 with fatty liver on CT scan. It tests whether a carnitine complex (GODEX®) reduces liver fat.
- Age
- 19 to 70 years
- Sex
- All sexes can join.
- Disease stage
- Fatty liver (hepatic steatosis) shown on non-contrast liver CT: liver-to-spleen difference under 10 HU, or liver attenuation under 40 HU.
- Earlier treatment
- Must not currently take prescribed liver-protecting drugs or liver supplements, and must not be attending a clinic for weight loss.
- Biomarker or test result
- AST or ALT liver tests at 40U/L for at least 3 months, or AST/ALT levels of 60U/L.
Main reasons for not taking part
- Heavy alcohol use (over 30g a day for men, over 20g a day for women) for 3 months
- Hormone problems that affect body weight, such as thyroid dysfunction
- Currently taking levodopa
- Chronic active hepatitis
- Pregnant or breastfeeding women
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects currently taking prescribed hepatoprotective agents or liver supplements at the time of enrollment.
- Patients currently receiving levodopa therapy.
Other illness
- Patients with endocrine disorders that may affect body weight, such as thyroid dysfunction.
- Patients with chronic active hepatitis.8) Pregnant or lactating women.
Lab values
- Patients with rare hereditary problems of galactose intolerance, total lactase deficiency (or Lapp lactase deficiency), or glucose-galactose malabsorption.
Other
- Subjects currently visiting obesity clinics or medical institutions for weight reduction purposes.
- Subjects with an average daily alcohol consumption exceeding 30g for men (approximately 3 standard drinks/glasses of soju) or 20g for women (approximately 2 standard drinks/glasses of soju) sustained for 3 months.
Who the study is looking for
- Living liver donors diagnosed with hepatic steatosis (or fatty liver)
- Living liver donors with a liver-to-spleen attenuation difference of <10 HU, or an absolute liver attenuation of <40 HU on non-contrast liver CT
- Living liver donors with AST or ALT levels persistent at 40U/L for at least 3 months, or AST/ALT levels 60U/L
- Living liver donors aged 19 to 70 years
Age in the registry: 19 years to 70 years · Sex: All · Does not accept healthy volunteers
The registry text, word for word
This page is information, not medical advice. Discuss any trial with your doctor.