Non-Alcoholic Fatty Liver DiseasePhase 3NCT06152991
Clinical Trial Assessing Godex Carnitine Orotate Complex in Nonalcoholic Fatty Liver Disease Patients for Efficacy
A Phase 3 study testing GODEX in people with Non-Alcoholic Fatty Liver Disease, run by Yoon Jun Kim at 1 site in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 to 74 years
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- GODEX
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 196 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Sep 2023to 26 Feb 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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).
Read the 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.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- GODEX, Placebo
- Keywords
- NAFLD, Non-Alcoholic Fatty Liver Diease, GODEX
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GODEXDrug
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
PlaceboDrug
- Anhydrous lactose 50mg.
- Colloidal silicon dioxide 12mg.
- Amorphous cellulose 50mg.
- Lactose monohydrate 215.625mg.
- Magnesium stearate 7mg.
- Upper and lower brown opaque capsules 77mg.
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Oral administration of 2 capsules of Godex® three times a day (tid) for 96 weeks Receives: Drug: GODEX |
| Control Group | Placebo comparator | Oral administration of 2 placebo capsules three times a day (tid) for 96 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48-week time point compared to baseline.
Secondary outcomes (15)
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.
Measured: 96-week time point compared to baseline.
Changes in hepatic fat content measured by MRI-PDFF at 96 weeks compared to baseline.
Present the mean and standard deviation (or median and IQR, if necessary) along with a 95% confidence interval for the intrahepatic fat measured by MRI-PDFF at baseline and at week 96, as well as the change from baseline to week 96 for each group. The comparison of intrahepatic fat at baseline and the change in intrahepatic fat at week 96 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.
Measured: 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.
- The percentage of subjects with a reduction of 20% or more in intrahepatic fat, as measured by MRI-PDFF at baseline compared to weeks 48 and 96, will be defined based on the % change. If the % change is 20% or greater, it will be considered a reduction.
- The comparison between the trial group and the control group regarding the percentage of subjects with a reduction of 20% or more in intrahepatic fat, as measured by MRI-PDFF at baseline compared to weeks 48 and 96, will be analyzed using Pearson's chi-square test or Fisher's exact test.
- Additionally, the reduction in intrahepatic fat will be categorized into three intervals: less than 20%, 30-50%, and 50% or more. The percentage of subjects with reduced intrahepatic fat in each interval for both the trial group and the control group will be compared using Pearson's chi-square test or Fisher's exact test.t.
Measured: 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.
- The percentage of subjects showing an improvement in liver fibrosis of 20% or more, as measured by MRE at baseline compared to week 96, will be defined based on the % change. An improvement will be considered when the % change is -20% or less.
- A comparative analysis between the test group and the control group regarding the percentage of subjects with an improvement in liver fibrosis of 20% or more, as measured by MRE at baseline compared to week 96, will be conducted using either Pearson's chi-square test or Fisher's exact test.
Measured: 48-week and 96-week time points compared to baseline.
Changes in CAP measured by Fibroscan at 48 and 96 weeks compared to baseline.
The mean and 95% confidence intervals for the changes in CAP (Controlled Attenuation Parameter) measured by Fibroscan at baseline compared to week 48 and week 96 are presented. Data normality will be assessed, and either a two-sample t-test or Wilcoxon's rank-sum test will be employed to perform a comparative analysis of the changes in CAP measured by Fibroscan at baseline compared to week 48 and week 96 between the test group and the control group.
Measured: 96-week time point compared to baseline.
Changes in LSM measured by Fibroscan at 48 and 96 weeks compared to baseline.
The mean and 95% confidence intervals for the changes in LSM (Liver Stiffness Measurement) measured by Fibroscan at baseline compared to week 48 and week 96 are presented. Data normality will be assessed, and either a two-sample t-test or Wilcoxon's rank-sum test will be employed to perform a comparative analysis of the changes in LSM measured by Fibroscan at baseline compared to week 48 and week 96 between the test group and the control group.
Measured: 96-week time point compared to baseline.
Changes in body weight at 48 and 96 weeks compared to baseline.
Mean and 95% confidence intervals for changes in body weight at baseline compared to weeks 48 and 96 are provided. Data normality will be assessed, and either a two-sample t-test or Wilcoxon's rank-sum test will be used to perform a comparative analysis of changes in body weight at baseline compared to weeks 48 and 96 between the test group and the control group.
Measured: 48-week and 96-week time points compared to baseline.
Changes in waist circumference at 48 and 96 weeks compared to baseline.
Mean and 95% confidence intervals for changes in body waist circumference at baseline compared to weeks 48 and 96 are provided. Data normality will be assessed, and either a two-sample t-test or Wilcoxon's rank-sum test will be used to perform a comparative analysis of changes in waist circumference at baseline compared to weeks 48 and 96 between the test group and the control group.
Measured: 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.
- Mean and 95% confidence intervals for changes in AST, ALT, and r-GTP at baseline compared to weeks 48 and 96 are provided. Data normality will be assessed, and either a two-sample t-test or Wilcoxon's rank-sum test will be used to perform a comparative analysis of changes in AST, ALT, and r-GTP at baseline compared to weeks 48 and 96 between the test group and the control group.
- The proportion of subjects in the test group and the control group with normalization of AST, ALT, and r-GTP at weeks 48 and 96 will be compared using Pearson's chi-square test or Fisher's exact test.
Measured: 48-week and 96-week time points compared to baseline.
Changes in HOMA-IR ≥2.0 at 48 and 96 weeks compared to baseline
- Mean and 95% confidence intervals for changes in insulin resistance (insulin resistance HOMA-IR ≥2.0) at baseline compared to weeks 48 and 96 are provided. Data normality will be assessed, and either a two-sample t-test or Wilcoxon's rank-sum test will be used to perform a comparative analysis of changes in insulin resistance (insulin resistance HOMA-IR ≥2.0) at baseline compared to weeks 48 and 96 between the test group and the control group.
Measured: 48-week and 96-week time points compared to baseline.
Changes in glycated hemoglobin (HbA1c) at 48 and 96 weeks compared to baseline
- Mean and 95% confidence intervals for changes in glycated hemoglobin (HbA1c) at baseline compared to weeks 48 and 96 are provided. Data normality will be assessed, and either a two-sample t-test or Wilcoxon's rank-sum test will be used to perform a comparative analysis of changes in glycated hemoglobin, at baseline compared to weeks 48 and 96 between the test group and the control group.
Measured: 48-week and 96-week time points compared to baseline.
Changes in fasting blood glucose at 48 and 96 weeks compared to baseline
- Mean and 95% confidence intervals for changes in fasting blood glucose at baseline compared to weeks 48 and 96 are provided. Data normality will be assessed, and either a two-sample t-test or Wilcoxon's rank-sum test will be used to perform a comparative analysis of changes in fasting blood glucose at baseline compared to weeks 48 and 96 between the test group and the control group.
Measured: 48-week and 96-week time points compared to baseline.
Changes in lipid profiles (total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides) at 48 and 96 weeks compared to baseline.
- Mean and 95% confidence intervals for changes in lipid profiles at baseline compared to weeks 48 and 96 are provided. Data normality will be assessed, and either a two-sample t-test or Wilcoxon's rank-sum test will be used to perform a comparative analysis of changes in lipid profiles at baseline compared to weeks 48 and 96 between the test group and the control group.
Measured: 48-week and 96-week time points compared to baseline.
Incidence of NAFLD risk factor diseases (hypertension, diabetes, dyslipidemia, etc.) at 48 and 96 weeks compared to baseline.
- Frequencies and incidence rates of NAFLD risk factor-related diseases in the test group and control group at baseline compared to weeks 48 and 96 are calculated, and 95% confidence intervals are provided. Pearson's chi-square test or Fisher's exact test will be used to analyze the difference in the incidence rates of NAFLD risk factor-related diseases at weeks 48 and 96 between the test group and the control group.
Measured: 48-week and 96-week time points compared to baseline.
Rate of medication discontinuation due to adverse events.
- The frequency and proportion of subjects who discontinued medication due to adverse events are presented according to adverse cases. The difference in medication discontinuation rates due to adverse events between the two groups will be compared using Pearson's chi-square test or Fisher's exact test.
Measured: during the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start25 Sep 2023
- Primary completion30 Jun 2026 (estimated)
- Study completion26 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-Blindle
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yoon Jun Kim
- Sponsor type
- University, hospital or other
- Collaborators
- Celltrion Pharm, Inc.
- Responsible party
- Sponsor-investigator, Yoon Jun Kim, Seoul National University Hospital
- Investigators
- YoonJun Kim, MD.PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06152991
- Sponsor's protocol ID
- UMTGODEX_001
- Status last verified
- Nov 2023
- First submitted
- 21 Sep 2023
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06152991
- Acronym / sponsor ID
- UMTGODEX_001
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Keywords
- NAFLD, Non-Alcoholic Fatty Liver Diease, GODEX
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Yoon Jun KimUniversity, hospital or other
- Collaborators
- Celltrion Pharm, Inc.
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 26 Feb 2027 (estimated)
- First posted
- 1 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-Blindle
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Drug: GODEXOral administration of 2 capsules of Godex® three times a day (tid) for 96 weeks |
| Control Group | Placebo comparator | Drug: PlaceboOral administration of 2 placebo capsules three times a day (tid) for 96 weeks |
Who may qualify
- Ages
- 19 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GODEXThe 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 | Test Group |
| 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. | Drug | Control Group |
Primary outcome
Change in intrahepatic fat content measured by MRI-PDFF
Time frame: 48-week time point compared to baseline.
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.
15 secondary outcomes
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.
Changes in lipid profiles (total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides) at 48 and 96 weeks compared to baseline.
Time frame: 48-week and 96-week time points compared to baseline.
Incidence of NAFLD risk factor diseases (hypertension, diabetes, dyslipidemia, etc.) at 48 and 96 weeks compared to baseline.
Time frame: 48-week and 96-week time points compared to baseline.
Rate of medication discontinuation due to adverse events.
Time frame: during the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
YoonJun Kim, MD.PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GODEX in people with Non-Alcoholic Fatty Liver Disease, run by Yoon Jun Kim at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in intrahepatic fat content measured by MRI-PDFF (time frame: 48-week time point compared to baseline.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023.