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

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

Study Overview

• Status: Recruiting
• Conditions: Dyslipidemias; T2DM (Type 2 Diabetes Mellitus)
• Intervention / Treatment: Drug: Ezetimibe/fenofibrate (Ezefeno) and moderate-intensity statin; Drug: Dose escalation of moderate-intensity statin

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 Type: Interventional
• Enrollment (Estimated): 3958
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: SIN-GON KIM; Phone Number: 8229205890; Email: k50367@korea.ac.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Korea University Anam Hospital
    • Contact: Sin Gon Kim, MD
    • Principal Investigator: Sin Gon Kim, MD, PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Study Population

Patients with type 2 diabetes, Dyslipidemias

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; Ezetimibe/fenofibrate (Ezefeno) and moderate-intensity statin	Drug: Ezetimibe/fenofibrate (Ezefeno) and moderate-intensity statin; Treatment group
Active Comparator: Control group; Dose escalation of moderate-intensity statin	Drug: Dose escalation of moderate-intensity statin; Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Korea University Anam Hospital
• Investigators: Principal Investigator: SIN-GON KIM, Korea University Anam Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: February 19, 2024
• First Submitted That Met QC Criteria: February 27, 2024
• First Posted (Actual): March 5, 2024

Study Record Updates

• Last Update Posted (Actual): August 27, 2024
• Last Update Submitted That Met QC Criteria: August 25, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Lipid Metabolism Disorders; Diabetes Mellitus, Type 2; Dyslipidemias; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Fenofibrate; Ezetimibe; Hydroxymethylglutaryl-CoA Reductase Inhibitors
• Other Study ID Numbers: HT-EF-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No