T2DM (Type 2 Diabetes Mellitus)ENSEMBLENCT06293417
To Assess With Ezefeno Tab. in Patients With Dyslipidemia and T2DM
A study testing Ezetimibe/fenofibrate (Ezefeno) and moderate-intensity statin and Dose escalation of moderate-intensity statin in people with T2DM (Type 2 Diabetes Mellitus) and Dyslipidemias, run by Korea University Anam Hospital at 1 site in South Korea.
Trial summary
The goal of this Randomized controlled trials is to assess in the long term efficacy and safety of ezefeno. The primary endpoint are: major adverse cardiovascular events within 48 months of the trial duration microvascular events within 48 months of the trial duration Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- T2DM (Type 2 Diabetes Mellitus), Dyslipidemias
- What is being tested?
- Ezetimibe/fenofibrate (Ezefeno) and moderate-intensity statin and Dose escalation of moderate-intensity statin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,958 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2024to 1 Feb 2027
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with type 2 diabetes diagnosed by American Diabetes Association criteria
- Age ≥ 19 years
- Non-HDL-C ≥100 mg/dL, TG ≥200, <500 mg/dL on moderate-intensity statins
- with cardiovascular risk factor
Who cannot join
- Pregnant or breastfeeding women
- Uncontrolled hyperglycemia(more than 12.0% for Subject treated with anti-diabetic treatment.)
- Patient with myopathy and rhabdomyolysis
- AST/ALT more than 3 ULN
- Clinical evidence of genetic disorders such as galactose intolerance, Lapp lactose deficiency, and/or glucose-galactose malabsorption
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Korea University Anam Hospital
Seoul
Sin Gon Kim, MD
Sin Gon Kim, MD, PHD
About this study
Official title: To Assess the Long-term Efficacy and Safety of Combined Therapy With Ezefeno Tab. in Patients With Dyslipidemia Who do Not Achieve Adequate Control of Non-HDL-C Levels Even With Moderate-intensity Monotherapy
The goal of this Randomized controlled trials is to assess in the long term efficacy and safety of ezefeno. The primary endpoint are:
- major adverse cardiovascular events within 48 months of the trial duration
- microvascular events within 48 months of the trial duration
Read the detailed description
A prospective, randomized, open-label, parallel, multicenter, active-drug-controlled clinical trial to assess the long-term efficacy and safety of Combined Therapy with Ezefeno Tab. in patients with dyslipidemia who do not achieve adequate control of Non-HDL-C levels even with Moderate-intensity monotherapy.
- Conditions
- T2DM (Type 2 Diabetes Mellitus), Dyslipidemias
- Being tested
- Ezetimibe/fenofibrate (Ezefeno) and moderate-intensity statin, Dose escalation of moderate-intensity statin
- Medical subject headings
- Diabetes Mellitus, Type 2, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ezetimibe/fenofibrate (Ezefeno) and moderate-intensity statinDrug
Treatment group
Dose escalation of moderate-intensity statinDrug
Control group
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Ezetimibe/fenofibrate (Ezefeno) and moderate-intensity statin Receives: Drug: Ezetimibe/fenofibrate (Ezefeno) and moderate-intensity statin |
| Control group | Active comparator | Dose escalation of moderate-intensity statin Receives: Drug: Dose escalation of moderate-intensity statin |
What is being measured
The primary outcome is the main question the study is designed to answer.
major adverse cardiovascular events and diabetic microvascular events for 48 months
major adverse cardiovascular events and diabetic microvascular events for 48 months
Measured: 48month from baseline
Secondary outcomes (8)
proportion of patients achieving Non-HDL-C less than 100mg/dL
proportion of patients achieving Non-HDL-C less than 100mg/dL
Measured: 48month from baseline
proportion of patients achieving LDL less than 70mg/dL
proportion of patients achieving LDL less than 70mg/dL
Measured: 48month from baseline
change in Non-HDL-C at 48month from baseline
change in Non-HDL-C at 48month from baseline
Measured: 48month from baseline
change in LDL at 48month from baseline
change in LDL at 48month from baseline
Measured: 48month from baseline
change in HDL-C at 48month from baseline
change in HDL-C at 48month from baseline
Measured: 48month from baseline
change in TG at 48month from baseline
change in TG at 48month from baseline
Measured: 48month from baseline
change in LDL-C/HDL-C ratio at 48month from baseline
change in LDL-C/HDL-C ratio at 48month from baseline
Measured: 48month from baseline
change in TC/HDL-C ratio at 48month from baseline
change in TC/HDL-C ratio at 48month from baseline
Measured: 48month from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start1 Mar 2024
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for T2DM (Type 2 Diabetes Mellitus)Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,958 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sin Gon Kim, Korea University Anam Hospital
- Investigators
- SIN-GON KIM, Principal investigator, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06293417
- Sponsor's protocol ID
- HT-EF-01
- Acronym
- ENSEMBLE
- Status last verified
- Aug 2024
- First submitted
- 19 Feb 2024
- Last updated
- 27 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kim NH, Lee J, Chon S, Yu JM, Jeong IK, Lim S, Kim WJ, Song K, Cho HC, Yu HM, Kim KA, Kim SS, Lee SH, Kim CH, Kwak SH, Lee YH, Chung CH, Lee S, Jin HY, Lee JH, Koh G, Kim SY, Kim J, Lee JH, Kim TN, Jeon HJ, Lee JH, Jeon JH, Yoo HJ, Kim HK, Park HK, Nam-Goong IS, Hong S, Ahn CW, Yu JH, Park JH, Park KG, Park CH, Joung KH, Ryu OH, Park KY, Hong EG, Cha BS, Won KC, Chung YS, Kim SG. Study Design and Protocol for a Randomized Controlled Trial to Assess Long-Term Efficacy and Safety of a Triple Combination of Ezetimibe, Fenofibrate, and Moderate-Intensity Statin in Patients with Type 2 Diabetes and Modifiable Cardiovascular Risk Factors (ENSEMBLE). Endocrinol Metab (Seoul). 2024 Oct;39(5):722-731. doi: 10.3803/EnM.2024.1995. Epub 2024 Aug 22.
PubMed 39174014
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Assess the Long-term Efficacy and Safety of Combined Therapy With Ezefeno Tab. in Patients With Dyslipidemia Who do Not Achieve Adequate Control of Non-HDL-C Levels Even With Moderate-intensity Monotherapy
- ClinicalTrials.gov ID
- NCT06293417
- Acronym / sponsor ID
- ENSEMBLE / HT-EF-01
- Conditions
- T2DM (Type 2 Diabetes Mellitus), Dyslipidemias
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,958 participants (estimated)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 5 Mar 2024 (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 goal of this Randomized controlled trials is to assess in the long term efficacy and safety of ezefeno. The primary endpoint are:
- major adverse cardiovascular events within 48 months of the trial duration
- microvascular events within 48 months of the trial duration
Detailed description
A prospective, randomized, open-label, parallel, multicenter, active-drug-controlled clinical trial to assess the long-term efficacy and safety of Combined Therapy with Ezefeno Tab. in patients with dyslipidemia who do not achieve adequate control of Non-HDL-C levels even with Moderate-intensity monotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Ezetimibe/fenofibrate (Ezefeno) and moderate-intensity statinEzetimibe/fenofibrate (Ezefeno) and moderate-intensity statin |
| Control group | Active comparator | Drug: Dose escalation of moderate-intensity statinDose escalation of moderate-intensity statin |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with type 2 diabetes diagnosed by American Diabetes Association criteria
- Age ≥ 19 years
- Non-HDL-C ≥100 mg/dL, TG ≥200, <500 mg/dL on moderate-intensity statins
- with cardiovascular risk factor
Key exclusion criteria (5 listed)
- Pregnant or breastfeeding women
- Uncontrolled hyperglycemia(more than 12.0% for Subject treated with anti-diabetic treatment.)
- Patient with myopathy and rhabdomyolysis
- AST/ALT more than 3 ULN
- Clinical evidence of genetic disorders such as galactose intolerance, Lapp lactose deficiency, and/or glucose-galactose malabsorption
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 |
|---|---|---|
| Ezetimibe/fenofibrate (Ezefeno) and moderate-intensity statinTreatment group | Drug | Treatment group |
| Dose escalation of moderate-intensity statinControl group | Drug | Control group |
Primary outcome
major adverse cardiovascular events and diabetic microvascular events for 48 months
Time frame: 48month from baseline
major adverse cardiovascular events and diabetic microvascular events for 48 months
8 secondary outcomes
proportion of patients achieving Non-HDL-C less than 100mg/dL
Time frame: 48month from baseline
proportion of patients achieving LDL less than 70mg/dL
Time frame: 48month from baseline
change in Non-HDL-C at 48month from baseline
Time frame: 48month from baseline
change in LDL at 48month from baseline
Time frame: 48month from baseline
change in HDL-C at 48month from baseline
Time frame: 48month from baseline
change in TG at 48month from baseline
Time frame: 48month from baseline
change in LDL-C/HDL-C ratio at 48month from baseline
Time frame: 48month from baseline
change in TC/HDL-C ratio at 48month from baseline
Time frame: 48month from baseline
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 27 Aug 2024.
- Derived from this study: PubMed 39174014Kim NH, Lee J, Chon S, Yu JM, Jeong IK, Lim S, Kim WJ, Song K, Cho HC, Yu HM, Kim KA, Kim SS, Lee SH, Kim CH, Kwak SH, Lee YH, Chung CH, Lee S, Jin HY, Lee JH, Koh G, Kim SY, Kim J, Lee JH, Kim TN, Jeon HJ, Lee JH, Jeon JH, Yoo HJ, Kim HK, Park HK, Nam-Goong IS, Hong S, Ahn CW, Yu JH, Park JH, Park KG, Park CH, Joung KH, Ryu OH, Park KY, Hong EG, Cha BS, Won KC, Chung YS, Kim SG. Study Design and Protocol for a Randomized Controlled Trial to Assess Long-Term Efficacy and Safety of a Triple Combination of Ezetimibe, Fenofibrate, and Moderate-Intensity Statin in Patients with Type 2 Diabetes and Modifiable Cardiovascular Risk Factors (ENSEMBLE). Endocrinol Metab (Seoul). 2024 Oct;39(5):722-731. doi: 10.3803/EnM.2024.1995. Epub 2024 Aug 22.
- Individual participant dataSharing planned: Undecided
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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.
SIN-GON KIM principal investigator
Korea University Anam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ezetimibe/fenofibrate (Ezefeno) and moderate-intensity statin and Dose escalation of moderate-intensity statin in people with T2DM (Type 2 Diabetes Mellitus) and Dyslipidemias, run by Korea University Anam 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 4 inclusion and 5 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 27 Aug 2024. 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.
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 SIN-GON KIM (8229205890, k50367@korea.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
major adverse cardiovascular events and diabetic microvascular events for 48 months (time frame: 48month from baseline). 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 NCT06293417, which also lists 1 linked publication.
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 27 Aug 2024; AzTrials last refreshed its copy on 8 Nov 2026.