DyslipidemiaPhase 4NCT05365425
Choline Fenofibrate and Carotid Atherosclerosis in Patients With Type 2 Diabetes and Combined Dyslipidemia
A Phase 4 study testing Choline fenofibrate and Policosanol in people with Dyslipidemia 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 choline fenofibrate compared with policosanol in Korean T2DM patients with asymptomatic atherosclerosis. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Dyslipidemia, Atherosclerosis, Diabetes Mellitus, Type 2
- What is being tested?
- Choline fenofibrate and Policosanol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2023to 31 Dec 2027
- 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 years and older
- 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: triglyceride 200~499 mg/dL, HDL-cholesterol male ≤45 mg/dL or female ≤50 mg/dL
- Identified carotid artery plaque: carotid intima-media thickness (cIMT) ≥ 1.0 mm
- 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
- Severe renal dysfunction
- GOT/GPT >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
- Other antiplatlet medication such as cilostazol, clopidogrel (except aspirin)
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, 01097662706, limsoo@snu.ac.kr
About this study
Official title: Effect of Choline Fenofibrate 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 choline fenofibrate compared with policosanol in Korean T2DM patients with asymptomatic atherosclerosis.
Read the detailed description
In patients with type 2 diabetes with atherosclerotic combined dyslipidemia, the effect of choline fenofibrate on the progression of carotid intima media thickness and carotid artery plaque will be evaluated by 3D carotid ultrasound.
- Conditions
- Dyslipidemia, Atherosclerosis, Diabetes Mellitus, Type 2
- Being tested
- Choline fenofibrate, Policosanol
- 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.
Choline fenofibrateDrug
Also called Tgfenon
choline fenofibrate 178.8mg (135mg as fenofibric acid)
PolicosanolDrug
Also called Policosanol 10
policosanol 10mg
| Study group | Role | What they receive |
|---|---|---|
| Tgfenon | Experimental | Choline fenofibrate (135mg as fenofibric acid) 1 tablet once daily oral administration regardless of diet Receives: Drug: Choline fenofibrate |
| Policosanol 10 | Active comparator | Policosanol 10mg 1 tablet once daily oral administration Receives: Drug: Policosanol |
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 week
Secondary outcomes (7)
Area of carotid artery plaque
measured by ultrasound
Measured: 24 week
Plaque characteristics
changes of non-calcified plaque volume (mm3)
Measured: 24 week
Glucose homeostasis
changes of HbA1c (%)
Measured: 24 week
Lipid metabolism
TG concentration, HDL-cholesterol concentration
Measured: 24 week
Bioelectrical Impedance Analysis
Body composition of fat mass (kg)
Measured: 24 week
Proteinuria
albumin-to-creatinine ratio (mg/g)
Measured: 24 week
changes of gut microbiota
measured by 16S rRNA or metagenome sequencing, comparing the composition or each phylum/genus/species
Measured: 24 week
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 Jun 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies 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
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Daewon Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Soo Lim, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05365425
- Sponsor's protocol ID
- B-2111-720-003
- Status last verified
- May 2026
- First submitted
- 16 Mar 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 Choline Fenofibrate on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes and Combined Dyslipidemia
- ClinicalTrials.gov ID
- NCT05365425
- Acronym / sponsor ID
- B-2111-720-003
- Conditions
- Dyslipidemia, Atherosclerosis, Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Collaborators
- Daewon Pharmaceutical Co., Ltd.
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (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 choline fenofibrate compared with policosanol in Korean T2DM patients with asymptomatic atherosclerosis.
Detailed description
In patients with type 2 diabetes with atherosclerotic combined dyslipidemia, the effect of choline fenofibrate 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
- 2
| Arm | Type | Receives |
|---|---|---|
| Tgfenon | Experimental | Drug: Choline fenofibrateCholine fenofibrate (135mg as fenofibric acid) 1 tablet once daily oral administration regardless of diet |
| Policosanol 10 | Active comparator | Drug: PolicosanolPolicosanol 10mg 1 tablet once daily oral administration |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 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: triglyceride 200~499 mg/dL, HDL-cholesterol male ≤45 mg/dL or female ≤50 mg/dL
- Identified carotid artery plaque: carotid intima-media thickness (cIMT) ≥ 1.0 mm
- Creatinine ≤1.8 mg/dL
Key exclusion criteria (7 listed)
- Dyslipidemia which requires other therapy: triglyceride ≥500 mg/dL or LDL-cholesterol ≥190 mg/dL
- Uncontrolled hypertension
- Severe renal dysfunction
- GOT/GPT >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 |
|---|---|---|
| Choline fenofibrateAlso: Tgfenoncholine fenofibrate 178.8mg (135mg as fenofibric acid) | Drug | Tgfenon |
| PolicosanolAlso: Policosanol 10policosanol 10mg | Drug | Policosanol 10 |
Primary outcome
Carotid intima media thickness
Time frame: 24 week
Maximum carotid IMT (mm)
7 secondary outcomes
Area of carotid artery plaque
Time frame: 24 week
Plaque characteristics
Time frame: 24 week
Glucose homeostasis
Time frame: 24 week
Lipid metabolism
Time frame: 24 week
Bioelectrical Impedance Analysis
Time frame: 24 week
Proteinuria
Time frame: 24 week
changes of gut microbiota
Time frame: 24 week
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 Choline fenofibrate and Policosanol in people with Dyslipidemia 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 5 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 week). 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.