DyslipidemiasPhase 4NCT05365438
Atmeg (Atorvastatin and Omega-3 Combination) and Carotid Atherosclerosis in Patients With Type 2 Diabetes and Combined Dyslipidemia
A Phase 4 study testing Omega 3-Atorvastatin and Atorvastatin-Ezetimibe in people with Dyslipidemias and Atherosclerosis, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
This is a randomized controlled study to assess the effect of atorvastatin and omega 3 combination therapy compared with atorvastatin and ezetimibe combination therapy in Korean T2DM patients with asymptomatic atherosclerosis. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Dyslipidemias, Atherosclerosis, Diabetes Mellitus, Type 2
- What is being tested?
- Omega 3-Atorvastatin and Atorvastatin-Ezetimibe
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Oct 2022to 31 Dec 2026
- Phase
- Phase 4
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes under treatment with HbA1c 6.0-10.0% at screening visit
- Male or female of 20 years or over
- Mixed dyslipidemia under moderate-intensity statin: triglyceride ≥200 mg/dL, HDL-cholesterol ≤50 mg/dL, LDL-cholesterol ≥100 mg/dL
- moderate-intensity statin: atorvastatin 10-20mg, rosuvastatin 5mg, simvastatin 20-40mg, pravastatin 40-80mg, lovastatin 40mg, fluvastatin XL 80mg, fluvastatin 40mg bid, pitavastatin 2-4mg
- Identified carotid artery plaque: carotid intima-media thickness (cIMT) ≥ 1.0 mm
- Asymptomatic patients without history of angina, myocardial infarction, or cerebral infarction
- Creatinine ≤1.8 mg/dL
Who cannot join
- Dyslipidemia which requires other therapy: triglyceride ≥500 mg/dL or LDL-cholesterol ≥190 mg/dL
- Uncontrolled hypertension: SBP >180 mmHg or DBP >110 mmHg
- Severe renal dysfunction: eGFR <30 mL/min/1.73m2
- AST/ALT >120/120 or chronic liver disease
- Pregnant or childbearing woman who does not have enough contraception
- Changes of medication related to chronic diseases (diabetes, hypertension, dyslipidemia, etc.) within 3 months
- Usage of dyslipidemia therapy other than statin
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Minji Sohn contact
South Korea1 site, 1 recruiting
- Recruiting
SNUBH
Seongnam-si, Gyeonggi-do, 13620
Soo Lim, MD, PHD, 01097662706, limsoo@snu.ac.kr
About this study
Official title: Effect of Atorvastatin and Omega 3 Combination Therapy on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes and Combined Dyslipidemia
This is a randomized controlled study to assess the effect of atorvastatin and omega 3 combination therapy compared with atorvastatin and ezetimibe combination therapy in Korean T2DM patients with asymptomatic atherosclerosis.
Read the detailed description
In patients with type 2 diabetes with atherosclerotic combined dyslipidemia, the effect of atorvastatin and omega 3 combination on the progression of carotid intima media thickness and carotid artery plaque will be evaluated by 3D carotid ultrasound.
- Conditions
- Dyslipidemias, Atherosclerosis, Diabetes Mellitus, Type 2
- Being tested
- Omega 3-Atorvastatin, Atorvastatin-Ezetimibe
- Medical subject headings
- Dyslipidemias, Atherosclerosis, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega 3-AtorvastatinDrug
Also called Atmeg-Omethyl cutielet
Atmeg 2 capsules with 1 pack of Omethyl cutielet
Omega 3-AtorvastatinDrug
Also called Atmeg
Atmeg 2 capsules
Atorvastatin-EzetimibeDrug
ezetimibe/atorvastatin 10/20 mg
| Study group | Role | What they receive |
|---|---|---|
| Atmeg with Omethyl Cutielet | Experimental | Atmeg: 2 capsules daily (1 capsule containes atorvastatin 10 mg and Omega-3 1000 mg) Omethyl Cutielet: Omega-3 2000mg (920mg as EPA ethyl ester, 760mg as DHA ethyl ester) once daily Receives: Drug: Omega 3-Atorvastatin |
| Atmeg | Active comparator | Atmeg: 2 capsules daily (1 capsule containes atorvastatin 10 mg and Omega-3 1000 mg) Receives: Drug: Omega 3-Atorvastatin |
| ezetimibe/atorvastatin 10/20 | Active comparator | 1 tablet once daily (atorvastatin 20mg with ezetimibe 10mg) Receives: Drug: Atorvastatin-Ezetimibe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carotid intima media thickness
maximum carotid IMT (mm)
Measured: 24 weeks
Secondary outcomes (7)
Area of carotid artery plaque
measured by ultrasound
Measured: 24 weeks
Plaque characteristics Plaque characteristics Plaque characteristics Plaque characteristics
changes of non-calcified plaque volume (mm3)
Measured: 24 weeks
Glucose homeostasis
changes of HbA1c (%)
Measured: 24 weeks
Lipid metabolism
TG concentration, HDL-cholesterol concentration
Measured: 24 weeks
Bioelectrical Impedance Analysis
Body composition of fat mass (kg)
Measured: 24 weeks
Proteinuria
albumin-to-creatinine ratio (mg/g)
Measured: 24 weeks
Changes of gut microbiota
measured by 16S rRNA or metagenome sequencing, comparing the composition or each phylum/genus/species
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start1 Oct 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiasStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Korea United Pharm. Inc.
- Responsible party
- Principal investigator, Soo Lim, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05365438
- Sponsor's protocol ID
- B-2111-720-004
- Status last verified
- May 2026
- First submitted
- 27 Apr 2022
- Last updated
- 5 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Atorvastatin and Omega 3 Combination Therapy on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes and Combined Dyslipidemia
- ClinicalTrials.gov ID
- NCT05365438
- Acronym / sponsor ID
- B-2111-720-004
- Conditions
- Dyslipidemias, Atherosclerosis, Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Collaborators
- Korea United Pharm. Inc.
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 May 2022 (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.
This is a randomized controlled study to assess the effect of atorvastatin and omega 3 combination therapy compared with atorvastatin and ezetimibe combination therapy in Korean T2DM patients with asymptomatic atherosclerosis.
Detailed description
In patients with type 2 diabetes with atherosclerotic combined dyslipidemia, the effect of atorvastatin and omega 3 combination on the progression of carotid intima media thickness and carotid artery plaque will be evaluated by 3D carotid ultrasound.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Atmeg with Omethyl Cutielet | Experimental | Drug: Omega 3-AtorvastatinAtmeg: 2 capsules daily (1 capsule containes atorvastatin 10 mg and Omega-3 1000 mg) Omethyl Cutielet: Omega-3 2000mg (920mg as EPA ethyl ester, 760mg as DHA ethyl ester) once daily |
| Atmeg | Active comparator | Drug: Omega 3-AtorvastatinAtmeg: 2 capsules daily (1 capsule containes atorvastatin 10 mg and Omega-3 1000 mg) |
| ezetimibe/atorvastatin 10/20 | Active comparator | Drug: Atorvastatin-Ezetimibe1 tablet once daily (atorvastatin 20mg with ezetimibe 10mg) |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Type 2 diabetes under treatment with HbA1c 6.0-10.0% at screening visit
- Male or female of 20 years or over
- Mixed dyslipidemia under moderate-intensity statin: triglyceride ≥200 mg/dL, HDL-cholesterol ≤50 mg/dL, LDL-cholesterol ≥100 mg/dL
- Identified carotid artery plaque: carotid intima-media thickness (cIMT) ≥ 1.0 mm
- Asymptomatic patients without history of angina, myocardial infarction, or cerebral infarction
Key exclusion criteria (7 listed)
- Dyslipidemia which requires other therapy: triglyceride ≥500 mg/dL or LDL-cholesterol ≥190 mg/dL
- Uncontrolled hypertension: SBP >180 mmHg or DBP >110 mmHg
- Severe renal dysfunction: eGFR <30 mL/min/1.73m2
- AST/ALT >120/120 or chronic liver disease
- Pregnant or childbearing woman who does not have enough contraception
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 |
|---|---|---|
| Omega 3-AtorvastatinAlso: Atmeg-Omethyl cutieletAtmeg 2 capsules with 1 pack of Omethyl cutielet | Drug | Atmeg with Omethyl Cutielet |
| Omega 3-AtorvastatinAlso: AtmegAtmeg 2 capsules | Drug | Atmeg |
| Atorvastatin-Ezetimibeezetimibe/atorvastatin 10/20 mg | Drug | ezetimibe/atorvastatin 10/20 |
Primary outcome
Carotid intima media thickness
Time frame: 24 weeks
maximum carotid IMT (mm)
7 secondary outcomes
Area of carotid artery plaque
Time frame: 24 weeks
Plaque characteristics Plaque characteristics Plaque characteristics Plaque characteristics
Time frame: 24 weeks
Glucose homeostasis
Time frame: 24 weeks
Lipid metabolism
Time frame: 24 weeks
Bioelectrical Impedance Analysis
Time frame: 24 weeks
Proteinuria
Time frame: 24 weeks
Changes of gut microbiota
Time frame: 24 weeks
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 5 May 2026.
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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.
Minji Sohn contact
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 Omega 3-Atorvastatin and Atorvastatin-Ezetimibe in people with Dyslipidemias and Atherosclerosis, run by Seoul National University Bundang Hospital 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 7 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 5 May 2026. 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?
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?
Contact Soo Lim (+82-31-787-7035, limsoo@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Carotid intima media thickness (time frame: 24 weeks). 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 5 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.