To Assess With Ezefeno Tab. in Patients With Dyslipidemia and T2DM

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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06293417

Acronym

ENSEMBLE

Enrollment

3958

Registered

2024-03-05

Start date

2024-03-01

Completion date

2027-02-01

Last updated

2024-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemias, T2DM (Type 2 Diabetes Mellitus)

Brief 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

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.

Interventions

DRUGEzetimibe/fenofibrate (Ezefeno) and moderate-intensity statin

Treatment group

DRUGDose escalation of moderate-intensity statin

Control group

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
major adverse cardiovascular events and diabetic microvascular events for 48 months	48month from baseline	major adverse cardiovascular events and diabetic microvascular events for 48 months

Secondary

Measure	Time frame	Description
proportion of patients achieving LDL less than 70mg/dL	48month from baseline	proportion of patients achieving LDL less than 70mg/dL
change in Non-HDL-C at 48month from baseline	48month from baseline	change in Non-HDL-C at 48month from baseline
change in LDL at 48month from baseline	48month from baseline	change in LDL at 48month from baseline
proportion of patients achieving Non-HDL-C less than 100mg/dL	48month from baseline	proportion of patients achieving Non-HDL-C less than 100mg/dL
change in TG at 48month from baseline	48month from baseline	change in TG at 48month from baseline
change in LDL-C/HDL-C ratio at 48month from baseline	48month from baseline	change in LDL-C/HDL-C ratio at 48month from baseline
change in TC/HDL-C ratio at 48month from baseline	48month from baseline	change in TC/HDL-C ratio at 48month from baseline
change in HDL-C at 48month from baseline	48month from baseline	change in HDL-C at 48month from baseline

Countries

South Korea

Contacts

Primary ContactSIN-GON KIM

k50367@korea.ac.kr8229205890

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026