Nonalcoholic Fatty Liver DiseasePhase 4NCT03434613
Phase IV Study to Evaluate the Effects of Statin Monotherapy or Statin / Ezetimibe Combination Therapy on Hepatic Steatosis in Patients With Hyperlipidemia and Nonalcoholic Fatty Liver Disease
A Phase 4 study testing Rosuvastatin and Rosuvastatin/ezetimibe combination in people with Nonalcoholic Fatty Liver Disease and Dyslipidemias, run by Yonsei University at 1 site in South Korea.
Trial summary
To investigate the therapeutic effect of ezetimibe on nonalcoholic fatty liver disease, the effect of rosuvastatin 5mg monotherapy and rosuvastatin 5mg / ezetimibe 10mg combination therapy n patients with hyperlipidemia and fatty liver will be compared and analyzed. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Nonalcoholic Fatty Liver Disease, Dyslipidemias
- What is being tested?
- Rosuvastatin and Rosuvastatin/ezetimibe combination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 May 2018to 11 Sep 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women ages 19 and over, under 80 years of age
- Patients diagnosed with fatty liver by abdominal ultrasonography or liver fibroscan. (In case of patients who were diagnosed fatty liver by liver scan, we will conduct abdominal ultrasonography for screening purposes)
- In the Domestic Dyslipidemia Treatment Guideline, patients with hyperlipidemia A. LDL-C is more than 130mg / dL when there is less than 1 major risk factor B. LDL-C 100 mg / dL or more if there are two or more major risk factors C. High-risk patients with carotid stenosis> 50%, abdominal aortic aneurysm, and diabetes mellitus had LDL-C> 70 mg / dL
- The main risk factors are as follows:
- smoking ii. Hypertension - systolic blood pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg or antihypertensive iii. Low HDL cholesterol (<40 mg / dL) iv. Age - Male 45+, Female 55+ v. Family history of early onset coronary artery disease - Parents, siblings with a history of coronary artery disease in men under 55 and women under 65 vi. High HDL cholesterol (60 mg / dL) or more is regarded as a protective factor and one of the total risk factors is reduced
- Even if it does not meet the criteria for hyperlipidemia, it is possible to select the subject when there is evidence of atherosclerosis on the test (carotid ultrasonography etc)
Show all 10Show fewer
- Those who already use statin as a treatment for hyperlipemia should participate after a washout period of 1-2 weeks.
- Controlled diabetic patients (HbA1c ≤9.0%), no change in type of oral or injectable hypoglycemic agents for the last 12 weeks
- Those who voluntarily agreed to participate in clinical trials after hearing the explanation of the clinical trial
- Those who understand the content of the clinical trial and are able to participate in the trial by the end of the clinical trial
Who cannot join
- Diabetic patients other than type 2 diabetes, including type 1 diabetes and gestational diabetes
- Those who have a previous history of medication with ezetimibe or discontinuation due to side effects after medication
- Patients who have had a history of discontinuation of statin therapy due to side effects after medication,
- Unregulated diabetic patients (those who have changed the type of oral or injectable hypoglycemic agent within 12 weeks prior to Visit 1 or who have HbA1c> 9.0% at screening time (Visit 1)
- patients with acute or chronic metabolic acidosis, including diabetic ketoacidosis with or without coma, and patients with a history of ketonic acidosis (within 6 months)
- Those who use thiazolidinedione and SGLT2i drugs which can affect fatty liver as a diabetes treatment drug
Show all 24Show fewer
- Patients who meet the criteria for alcoholism in fatty liver disease (210 g / week for men in the last two years, 140 g / week for women)
- Chronic liver disease (including hemochromatosis, liver cancer, autoimmune liver disease, Child-Pugh score> 7points, platelet <75,000mm2, prothrombin time> 16s), viral hepatitis -A, B,
- People who take drugs that can cause fatty liver (amiodarone, methotrexate, tamoxifen, valproate, corticosteroids, etc.)
- Patients who are allergic or hypersensitive to the drug or its constituents
- Patients who were treated with oral or parenteral corticosteroids chronic (within consecutive 14 days) within 8 weeks before screening
- Patients with genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder
- Patients with malnutrition, starvation, weakness (including severe infections, pre- and post-operative trauma patients), pituitary dysfunction or adrenal insufficiency
- Serum levels of alanine aminotransferase, aspartate aminotransferase or alkaline phosphatase are increased over 5-fold elevation of the normal range upper limit [ULN] or 5-fold elevation of the serum total bilirubin level. )
- Currently taking medication for weight loss
- Patients with a history of malignant tumors within the past 2 years or malignant tumors that are currently undergoing treatment or progression
- Patients with a history of substance abuse or alcohol intoxication within 12 weeks
- Human immunodeficiency virus (HIV)
- Patients with severe infection, pre- and post-operative, and severe trauma
- Patients with acute cardiovascular disease within 12 weeks (patients with unstable angina, myocardial infarction, transient ischemic attack, cerebrovascular disease, coronary artery bypass grafting, or coronary intervention)
- Patients with renal failure, chronic renal disease (estimated glomerular filtration rate <60 mL / min / 1.73 m2)
- Anemic patients with a Hb level of less than 10.5 g / dl
- Surgical or medical conditions that may affect the absorption, distribution, metabolism and excretion of a drug, including, but not limited to, gastrectomy, gastroenterostomy, History of major gastrointestinal surgery such as small bowel resection, gastrointestinal bypass, gastrointestinal stapling, current active gastritis, gastrointestinal / rectal bleeding, active inflammatory bowel syndrome within the last 12 months, etc.
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University College of Medicine, Department of Internal Medicine, Division of Endocrinology, Severance Hospital, Diabetes center
Seoul, 03722
About this study
Official title: A Randomized, Prospective, Open Label, Active Control, Phase IV Study to Evaluate the Effects of Statin Monotherapy or Statin / Ezetimibe Combination Therapy on Hepatic Steatosis in Patients With Hyperlipidemia and Nonalcoholic Fatty Liver Disease
To investigate the therapeutic effect of ezetimibe on nonalcoholic fatty liver disease, the effect of rosuvastatin 5mg monotherapy and rosuvastatin 5mg / ezetimibe 10mg combination therapy n patients with hyperlipidemia and fatty liver will be compared and analyzed.
This study included a total of 70 patients (35 per subgroup) for randomized controlled trials with prospective, open label, randomized, single-institution clinical trials.
The drug will be maintained for a total of six months. The primary endpoint is the difference of liver fat change measured by MRI-PDFF in colocalized regions of interest within nine liver segments between two groups.
- Conditions
- Nonalcoholic Fatty Liver Disease, Dyslipidemias
- Being tested
- Rosuvastatin, Rosuvastatin/ezetimibe combination
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Rosuvastatin 5mg 1T daily for 6 months
Rosuvastatin/ezetimibe combinationDrug
Rosuvastatin 5mg / Ezetimibe 10mg combination 1T daily for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin monotherapy | Active comparator | Rosuvastatin 5mg 1T daily for 6 months Receives: Drug: Rosuvastatin |
| Rosuvastatin + ezetimibe combination therapy | Experimental | Rosuvastatin 5mg / Ezetimibe 10mg combination 1T daily for 6 months Receives: Drug: Rosuvastatin/ezetimibe combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
liver fat change measured by MRI-PDFF in colocalized regions of interest within each of nine liver segments
MRI is used to measure the fat fraction in 9 liver segments, and this test has been reported to be more sensitive than the biopsy-based steatosis grade assessment in confirming liver fat changes in previous studies
Measured: 6 months
Secondary outcomes (20)
Liver fibrosis measured by MRE(magnetic resonance elastography)
The secondary endpoint is to analyze the changes before and after drug administration for the following items: Liver fibrosis measured by magnetic resonance elastography
Measured: 6 months
Change in hepatic steatosis index - controlled attenuation parameter (CAP)
The secondary endpoint is to analyze the changes before and after drug administration for the following items: controlled attenuation parameter (CAP)
Measured: 6 months
Change in hepatic fibrosis index - liver stiffness measurement (LSM) measured by transient liver elastography (Fibroscan®; Echosens, Paris, France)
The secondary endpoint is to analyze the changes before and after drug administration for the following items: liver stiffness measurement (LSM) measured by fibroscan
Measured: 6 months
Changes in body weight (kg) before and after the administration of rosuvastatin with/without ezetimibe
The secondary endpoint is to analyze the changes before and after drug administration for the following items: body weight
Measured: 6 months
Changes in waist circumference (cm) before and after the administration of rosuvastatin with/without ezetimibe
The secondary endpoint is to analyze the changes before and after drug administration for the following items: WC
Measured: 6 months
Changes in systolic & diastolic blood pressure (mmHg) before and after the administration of rosuvastatin with/without ezetimibe
The secondary endpoint is to analyze the changes before and after drug administration for the following items: SBP, DBP
Measured: 6 months
Changes in serum concentrations of insulin (µU/mL), before and after the administration of rosuvastatin with/without ezetimibe
The secondary endpoint is to analyze the changes before and after drug administration for the following items: fasting insulin
Measured: 6 months
Changes in serum concentrations of fasting glucose (mg/dL), before and after the administration of rosuvastatin with/without ezetimibe
The secondary endpoint is to analyze the changes before and after drug administration for the following items: fasting glucose
Measured: 6 months
Changes in serum concentrations of HbA1c (percent), before and after the administration of rosuvastatin with/without ezetimibe
The secondary endpoint is to analyze the changes before and after drug administration for the following items: HbA1c
Measured: 6 months
Change in insulin sensitivity determined by homeostatic model assessment insulin resistance (HOMA-IR) and beta cell function determined by HOMA-beta
The secondary endpoint is to analyze the changes before and after drug administration for the following items: HOMAIR, HOMA-beta
Measured: 6 months
Changes in serum concentrations of free fatty acid (μEq/L), before and after the administration of rosuvastatin with/without ezetimibe
The secondary endpoint is to analyze the changes before and after drug administration for the following items: free fatty acid
Measured: 6 months
Changes in serum concentrations of platelet (×103/ μL), before and after the administration of rosuvastatin with/without ezetimibe
The secondary endpoint is to analyze the changes before and after drug administration for the following items: platelet
Measured: 6 months
Changes in serum concentrations of alkaline phosphate (U/L) and gamma-GT(U/L), before and after the administration of rosuvastatin with/without ezetimibe
The secondary endpoint is to analyze the changes before and after drug administration for the following items: Alk,phos, GGT
Measured: 6 months
Changes in serum concentrations of total bilirubin (mg/dL), before and after the administration of rosuvastatin with/without ezetimibe
The secondary endpoint is to analyze the changes before and after drug administration for the following items: total bilirubin
Measured: 6 months
Changes in serum concentrations of liver enzymes (aspartate aminotransferase and alanine aminotransferase (IU/L)), before and after the administration of rosuvastatin with/without ezetimibe
The secondary endpoint is to analyze the changes before and after drug administration for the following items: ALT, AST
Measured: 6 months
Changes in serum lipids (total cholesterol, triglyceride, HDL cholesterol, and LDL cholesterol (mg/dL)), before and after the administration of rosuvastatin with/without ezetimibe
The secondary endpoint is to analyze the changes before and after drug administration for the following items: LDL-C, TG, HDL, TC
Measured: 6 months
Changes in serum concentrations of CRP (mg/dL), before and after the administration of rosuvastatin with/without ezetimibe
The secondary endpoint is to analyze the changes before and after drug administration for the following items: High-sensitivity CRP
Measured: 6 months
Changes in the level of liver injury markers including IL-1beta, IL-8, IL-18 (pg/mL) before and after the administration of rosuvastatin with/without ezetimibe
The secondary endpoint is to analyze the changes before and after drug administration for the following items: biomarker ( IL-1b, IL-8, IL18)
Measured: 6 months
Changes in plasminogen activator inhibitor-1 (ng/mL) in peripheral blood mononuclear cells, before and after the administration of rosuvastatin with/without ezetimibe
The secondary endpoint is to analyze the changes before and after drug administration for the following items: tPAI-1
Measured: 6 months
Changes in BMI (kg/m^2) before and after the administration of rosuvastatin with/without ezetimibe
The secondary endpoint is to analyze the changes before and after drug administration for the following items: BMI
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study start14 May 2018
- Primary completion11 Sep 2019
- Study completion11 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nonalcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will conduct to evaluate the efficacy of liver fat lowering and safety of rosuvastatin 5mg alone or in combination with rosuvastatin 5mg / ezetimibe 10mg for 6 months.
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03434613
- Sponsor's protocol ID
- 4-2017-1168
- Status last verified
- Jul 2021
- First submitted
- 9 Feb 2018
- Last updated
- 9 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Loomba R, Sirlin CB, Ang B, Bettencourt R, Jain R, Salotti J, Soaft L, Hooker J, Kono Y, Bhatt A, Hernandez L, Nguyen P, Noureddin M, Haufe W, Hooker C, Yin M, Ehman R, Lin GY, Valasek MA, Brenner DA, Richards L; San Diego Integrated NAFLD Research Consortium (SINC). Ezetimibe for the treatment of nonalcoholic steatohepatitis: assessment by novel magnetic resonance imaging and magnetic resonance elastography in a randomized trial (MOZART trial). Hepatology. 2015 Apr;61(4):1239-50. doi: 10.1002/hep.27647. Epub 2015 Feb 27.
PubMed 25482832Cho Y, Rhee H, Kim YE, Lee M, Lee BW, Kang ES, Cha BS, Choi JY, Lee YH. Ezetimibe combination therapy with statin for non-alcoholic fatty liver disease: an open-label randomized controlled trial (ESSENTIAL study). BMC Med. 2022 Mar 21;20(1):93. doi: 10.1186/s12916-022-02288-2.
PubMed 35307033
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Prospective, Open Label, Active Control, Phase IV Study to Evaluate the Effects of Statin Monotherapy or Statin / Ezetimibe Combination Therapy on Hepatic Steatosis in Patients With Hyperlipidemia and Nonalcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT03434613
- Acronym / sponsor ID
- 4-2017-1168
- Conditions
- Nonalcoholic Fatty Liver Disease, Dyslipidemias
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 14 May 2018 (actual)
- Primary completion
- 11 Sep 2019 (actual)
- Study completion
- 11 Sep 2019 (actual)
- First posted
- 15 Feb 2018 (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.
To investigate the therapeutic effect of ezetimibe on nonalcoholic fatty liver disease, the effect of rosuvastatin 5mg monotherapy and rosuvastatin 5mg / ezetimibe 10mg combination therapy n patients with hyperlipidemia and fatty liver will be compared and analyzed.
This study included a total of 70 patients (35 per subgroup) for randomized controlled trials with prospective, open label, randomized, single-institution clinical trials.
The drug will be maintained for a total of six months. The primary endpoint is the difference of liver fat change measured by MRI-PDFF in colocalized regions of interest within nine liver segments between two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study will conduct to evaluate the efficacy of liver fat lowering and safety of rosuvastatin 5mg alone or in combination with rosuvastatin 5mg / ezetimibe 10mg for 6 months.
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin monotherapy | Active comparator | Drug: RosuvastatinRosuvastatin 5mg 1T daily for 6 months |
| Rosuvastatin + ezetimibe combination therapy | Experimental | Drug: Rosuvastatin/ezetimibe combinationRosuvastatin 5mg / Ezetimibe 10mg combination 1T daily for 6 months |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Men or women ages 19 and over, under 80 years of age
- Patients diagnosed with fatty liver by abdominal ultrasonography or liver fibroscan. (In case of patients who were diagnosed fatty liver by liver scan, we will conduct abdominal ultrasonography for screening purposes)
- In the Domestic Dyslipidemia Treatment Guideline, patients with hyperlipidemia A. LDL-C is more than 130mg / dL when there is less than 1 major risk factor B. LDL-C 100 mg / dL or more if there are two or more major risk factors C. High-risk patients with carotid stenosis> 50%, abdominal aortic aneurysm, and diabetes mellitus had LDL-C> 70 mg / dL
- The main risk factors are as follows:
- smoking ii. Hypertension - systolic blood pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg or antihypertensive iii. Low HDL cholesterol (<40 mg / dL) iv. Age - Male 45+, Female 55+ v. Family history of early onset coronary artery disease - Parents, siblings with a history of coronary artery disease in men under 55 and women under 65 vi. High HDL cholesterol (60 mg / dL) or more is regarded as a protective factor and one of the total risk factors is reduced
Key exclusion criteria (24 listed)
- Diabetic patients other than type 2 diabetes, including type 1 diabetes and gestational diabetes
- Those who have a previous history of medication with ezetimibe or discontinuation due to side effects after medication
- Patients who have had a history of discontinuation of statin therapy due to side effects after medication,
- Unregulated diabetic patients (those who have changed the type of oral or injectable hypoglycemic agent within 12 weeks prior to Visit 1 or who have HbA1c> 9.0% at screening time (Visit 1)
- patients with acute or chronic metabolic acidosis, including diabetic ketoacidosis with or without coma, and patients with a history of ketonic acidosis (within 6 months)
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 |
|---|---|---|
| RosuvastatinRosuvastatin 5mg 1T daily for 6 months | Drug | Rosuvastatin monotherapy |
| Rosuvastatin/ezetimibe combinationRosuvastatin 5mg / Ezetimibe 10mg combination 1T daily for 6 months | Drug | Rosuvastatin + ezetimibe combination therapy |
Primary outcome
liver fat change measured by MRI-PDFF in colocalized regions of interest within each of nine liver segments
Time frame: 6 months
MRI is used to measure the fat fraction in 9 liver segments, and this test has been reported to be more sensitive than the biopsy-based steatosis grade assessment in confirming liver fat changes in previous studies
20 secondary outcomes
Liver fibrosis measured by MRE(magnetic resonance elastography)
Time frame: 6 months
Change in hepatic steatosis index - controlled attenuation parameter (CAP)
Time frame: 6 months
Change in hepatic fibrosis index - liver stiffness measurement (LSM) measured by transient liver elastography (Fibroscan®; Echosens, Paris, France)
Time frame: 6 months
Changes in body weight (kg) before and after the administration of rosuvastatin with/without ezetimibe
Time frame: 6 months
Changes in waist circumference (cm) before and after the administration of rosuvastatin with/without ezetimibe
Time frame: 6 months
Changes in systolic & diastolic blood pressure (mmHg) before and after the administration of rosuvastatin with/without ezetimibe
Time frame: 6 months
Changes in serum concentrations of insulin (µU/mL), before and after the administration of rosuvastatin with/without ezetimibe
Time frame: 6 months
Changes in serum concentrations of fasting glucose (mg/dL), before and after the administration of rosuvastatin with/without ezetimibe
Time frame: 6 months
Changes in serum concentrations of HbA1c (percent), before and after the administration of rosuvastatin with/without ezetimibe
Time frame: 6 months
Change in insulin sensitivity determined by homeostatic model assessment insulin resistance (HOMA-IR) and beta cell function determined by HOMA-beta
Time frame: 6 months
Changes in serum concentrations of free fatty acid (μEq/L), before and after the administration of rosuvastatin with/without ezetimibe
Time frame: 6 months
Changes in serum concentrations of platelet (×103/ μL), before and after the administration of rosuvastatin with/without ezetimibe
Time frame: 6 months
Changes in serum concentrations of alkaline phosphate (U/L) and gamma-GT(U/L), before and after the administration of rosuvastatin with/without ezetimibe
Time frame: 6 months
Changes in serum concentrations of total bilirubin (mg/dL), before and after the administration of rosuvastatin with/without ezetimibe
Time frame: 6 months
Changes in serum concentrations of liver enzymes (aspartate aminotransferase and alanine aminotransferase (IU/L)), before and after the administration of rosuvastatin with/without ezetimibe
Time frame: 6 months
Changes in serum lipids (total cholesterol, triglyceride, HDL cholesterol, and LDL cholesterol (mg/dL)), before and after the administration of rosuvastatin with/without ezetimibe
Time frame: 6 months
Changes in serum concentrations of CRP (mg/dL), before and after the administration of rosuvastatin with/without ezetimibe
Time frame: 6 months
Changes in the level of liver injury markers including IL-1beta, IL-8, IL-18 (pg/mL) before and after the administration of rosuvastatin with/without ezetimibe
Time frame: 6 months
Changes in plasminogen activator inhibitor-1 (ng/mL) in peripheral blood mononuclear cells, before and after the administration of rosuvastatin with/without ezetimibe
Time frame: 6 months
Changes in BMI (kg/m^2) before and after the administration of rosuvastatin with/without ezetimibe
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2021.
- Background: PubMed 25482832Loomba R, Sirlin CB, Ang B, Bettencourt R, Jain R, Salotti J, Soaft L, Hooker J, Kono Y, Bhatt A, Hernandez L, Nguyen P, Noureddin M, Haufe W, Hooker C, Yin M, Ehman R, Lin GY, Valasek MA, Brenner DA, Richards L; San Diego Integrated NAFLD Research Consortium (SINC). Ezetimibe for the treatment of nonalcoholic steatohepatitis: assessment by novel magnetic resonance imaging and magnetic resonance elastography in a randomized trial (MOZART trial). Hepatology. 2015 Apr;61(4):1239-50. doi: 10.1002/hep.27647. Epub 2015 Feb 27.
- Derived from this study: PubMed 35307033Cho Y, Rhee H, Kim YE, Lee M, Lee BW, Kang ES, Cha BS, Choi JY, Lee YH. Ezetimibe combination therapy with statin for non-alcoholic fatty liver disease: an open-label randomized controlled trial (ESSENTIAL study). BMC Med. 2022 Mar 21;20(1):93. doi: 10.1186/s12916-022-02288-2.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rosuvastatin and Rosuvastatin/ezetimibe combination in people with Nonalcoholic Fatty Liver Disease and Dyslipidemias, run by Yonsei University 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 10 inclusion and 24 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: finished, as of the sponsor's last update on 9 Jul 2021. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
liver fat change measured by MRI-PDFF in colocalized regions of interest within each of nine liver segments (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03434613, which also lists 2 linked publications.
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 9 Jul 2021.