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Can Omega-3 boost statins to fight artery plaque in diabetes?

NCT ID NCT05365438

Disease control Sponsor: Seoul National University Bundang Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether adding omega-3 to a common statin (atorvastatin) can better reduce plaque buildup in the neck arteries of people with type 2 diabetes and high cholesterol. About 105 adults will be randomly assigned to get either atorvastatin plus omega-3 or atorvastatin plus another drug (ezetimibe). The goal is to see which combo works best to slow or shrink plaque, measured by ultrasound over time.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 105 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

atherosclerosis carotid stenosis Dyslipidemias hyperlipidemia hyperlipidemia, familial combined, LPL related inherited lipid metabolism disorder type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atherosclerosis Diabetes mellitus type 2 Dyslipidemias

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • SNUBH

    RECRUITING

    Seongnam-si, Gyeonggi-do, 13620, South Korea

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