To Assess With Ezefeno Tab. in Patients With Dyslipidemia and T2DM
ENSEMBLE
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
1 other identifier
interventional
3,958
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2024
CompletedStudy Start
First participant enrolled
March 1, 2024
CompletedFirst Posted
Study publicly available on registry
March 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
August 27, 2024
August 1, 2024
2.9 years
February 19, 2024
August 25, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
major adverse cardiovascular events and diabetic microvascular events for 48 months
major adverse cardiovascular events and diabetic microvascular events for 48 months
48month from baseline
Secondary Outcomes (8)
proportion of patients achieving Non-HDL-C less than 100mg/dL
48month from baseline
proportion of patients achieving LDL less than 70mg/dL
48month from baseline
change in Non-HDL-C at 48month from baseline
48month from baseline
change in LDL at 48month from baseline
48month from baseline
change in HDL-C at 48month from baseline
48month from baseline
- +3 more secondary outcomes
Study Arms (2)
Treatment group
EXPERIMENTALEzetimibe/fenofibrate (Ezefeno) and moderate-intensity statin
Control group
ACTIVE COMPARATORDose escalation of moderate-intensity statin
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Korea University Anam Hospital
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
SIN-GON KIM
Korea University Anam Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
February 19, 2024
First Posted
March 5, 2024
Study Start
March 1, 2024
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
February 1, 2027
Last Updated
August 27, 2024
Record last verified: 2024-08