Dual vs Triple Lipid-Lowering Therapy in Type 2 Diabetes Mellitus Patients With Elevated LDL Cholesterol

June 23, 2026 updated by: Dr.Fatima khatoon, Bahria University

Comparative Efficacy and Safety of Dual Versus Triple Lipid-Lowering Therapies (Rosuvastatin/Ezetimibe, Bempedoic Acid/Ezetimibe, and Rosuvastatin/Ezetimibe/Bempedoic Acid ) in Type 2 Diabetes Mellitus Patients With Elevated LDL Cholesterol

This Open-label, randomized clinical trial evaluates the comparative efficacy and safety of dual versus triple lipid-lowering therapy using rosuvastatin, ezetimibe, and bempedoic acid in patients with type 2 diabetes mellitus and elevated LDL cholesterol. The study aims to determine whether adding bempedoic acid to standard dual therapy provides superior lipid control without compromising safety. The 126 participants, aged 35 - 60 years will be randomly assigned to one of three treatment groups for 12 weeks, and their lipid profiles, glycemic control, and adverse effects will be monitored.The total duration of study will be 6 months, with a 3 months individual treatment period.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a single-center, randomized, open-label clinical trial conducted over a 12-week period to evaluate the comparative efficacy and safety of dual versus triple lipid-lowering therapy in patients with type 2 diabetes mellitus (T2DM) and elevated LDL cholesterol (LDL-C).

The trial includes three treatment arms, Arm A will receive Rosuvastatin + Ezetimibe, Arm B will receive Bempedoic Acid + Ezetimibe and Arm C will receive Rosuvastatin + Ezetimibe + Bempedoic Acid.

Eligible participants are adults aged 35 - 60 years with a confirmed diagnosis of type 2 diabetes mellitus and elevated LDL cholesterol despite standard care. Exclude patients with severe hepatic or renal impairment, history of gout or hyperuricemia, muscle disorders or previous statin intolerance or Participation in another clinical trial within 30 days All participants will be randomly assigned to one of the three arms. Baseline assessments include lipid profile (TC, TG, HDL, LDL, VLDL), glycemic parameters (FBS, RBS, HbA1c), creatine kinase, uric acid, and documentation of medical history and concomitant medications. Follow-up assessments will occur at week 12 to evaluate changes in primary and secondary outcomes.

The primary outcome is change in LDL cholesterol from baseline to 12 weeks and secondary Outcomes include total cholesterol (TC), high-density lipoprotein (HDL), triglycerides (TG), very-low-density lipoprotein (VLDL), creatine kinase (CK), Uric acid, glycemic control like HbA1c, fasting blood sugar (FBS), random blood sugar (RBS), safety and tolerability including muscle spasm, myalgia, or gout attacks Safety Monitoring through all adverse events will be recorded during the study. If participants reporting muscle symptoms or hyperuricemia will be evaluated promptly. Laboratory tests will be repeated at study completion or earlier if clinically indicated.

This study is designed to assess whether the addition of bempedoic acid to standard dual therapy provides superior lipid-lowering efficacy without increasing adverse events in T2DM patients with elevated LDL-C. The findings will inform clinical practice on optimal lipid-lowering strategies for high-risk diabetic patients.

The study has received approval from BUHS-IRB (#180/25) and will be conducted in accordance with Good Clinical Practice (GCP) guidelines. Written informed consent will be obtained from all participants before study procedures.

Study Type

Interventional

Enrollment (Estimated)

126

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 75500
        • Recruiting
        • National Medical Center
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Fatima Khatoon, MBBS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Males and females
  • Age 35-60 years
  • HbA1c ≥ 7.0 (≥ 48 mmol/mol)
  • On stable anti-diabetic therapy for at least 3 months
  • LDL-C > 100 mg/dL on at least two occasions
  • Diagnosed with hypercholesterolemia
  • Establish high cardiovascular risk (e.g, previous MI, stroke or atherosclerosis) or
  • ≥2 cardiovascular risk factors (hypertension, smoking, obesity, family history)
  • BMI >23 - <32(WHO Asian Criteria)
  • No prior statin side effects

Exclusion Criteria:

  • HbA1c >10 % (86 mmol/mol)
  • BMI > 32
  • Type 1 Diabetes, gestational diabetes
  • Pregnancy or lactation
  • Acute liver disease or ALT/AST levels > 3× the upper limit of normal
  • Renal failure (GFR < 30 mL/min)
  • Uncontrolled hypothyroidism or nephrotic syndrome
  • Recent cancer diagnosis (last 6 months)
  • Current use of other lipid-lowering agents (e.g., fibrates or PCSK9 inhibitors)
  • Known allergy to any component
  • Statin intolerance with severe adverse effects (e.g., rhabdomyolysis)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Rosuvastatin + Ezetimibe
Rosuvastatin is a statin that lowers LDL cholesterol by inhibiting HMG-CoA reductase. Ezetimibe inhibits cholesterol absorption in the intestine.
Drug: Rosuvastatin + Ezetimibe
Group A (Dual therapy 1): Tab Rosuvastatin 20 mg + Tab Ezetimibe 10mg (FDC) orally, once daily for 90 days
Active Comparator: Bempedoic Acid + Ezetimibe
Bempedoic acid is an ATP citrate lyase inhibitor that reduces LDL cholesterol. Ezetimibe inhibits diatery cholesterol absorption in the intestine
Drug: Bempedoic Acid + Ezetimibe
Group B (Dual therapy 2): Tab Bempedoic Acid 180mg+ Tab Ezetimibe 10mg (FDC) orally, once daily for 90 days
Active Comparator: Rosuvastatin + Ezetimibe + Bempedoic Acid
This triple therapy combines statin therapy with cholesterol absorption inhibition and ATP citrate lyase inhibition to optimize LDL reduction.
Drug: Rosuvastatin + Ezetimibe + Bempedoic Acid
Group C (Triple therapy): Tab Rosuvastatin 20 mg+ Tab Ezetimibe 10mg+ Tab Bempedoic Acid 180mg orally, once daily for 90 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary outcome: Percent Change in LDL-C From Baseline to 12 Weeks and Proportion of Participants Achieving LDL-C <70 mg/dL
Time Frame: 12 weeks
The study will measure the percent change in LDL-C from baseline to 12 weeks and the proportion of participants achieving LDL-C <70 mg/dL as per international guidelines.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary outcome : Change in Total Cholesterol Level From Baseline to 12 Weeks (mg/dL)
Time Frame: 12 weeks
The study will measure the change in total cholesterol (mg/dL) from baseline to 12 weeks to evaluate the efficacy of dual and triple lipid-lowering therapies.
12 weeks
Secondary Outcome : Change in Triglyceride Level From Baseline to 12 Weeks (mg/dL)
Time Frame: 12 weeks
The study will measure the change in Triglyceride Level from baseline to 12 weeks to evaluate the efficacy of dual and triple lipid-lowering therapies.
12 weeks
Secondary Outcome : Change in HDL-C Level From Baseline to 12 Weeks (mg/dL)
Time Frame: 12 weeks
The study will measure the change in HDL-C Level from baseline to 12 weeks to evaluate the efficacy of dual and triple lipid-lowering therapies.
12 weeks
Secondary Outcome : Change in VLDL Level From Baseline to 12 Weeks (mg/dL)
Time Frame: 12 weeks
The study will measure the change in VLDL Level from baseline to 12 weeks to evaluate the efficacy of dual and triple lipid-lowering therapies.
12 weeks
Secondary Outcome (Safety - Muscle Marker): Change in Creatine Kinase (CK) Level From Baseline to 12 Weeks (U/L)
Time Frame: 12 weeks
The study will monitor creatine kinase levels from baseline to 12 weeks to assess muscle-related safety of the therapies
12 weeks
Secondary Outcome (Safety - Metabolic Marker): Change in Uric Acid Level From Baseline to 12 Weeks (mg/dL)
Time Frame: 12 weeks
The study will monitor uric acid levels from baseline to 12 weeks to assess the metabolic safety of the therapies.
12 weeks
Secondary Outcome (Adverse Events): Number of Participants Experiencing Treatment-Related Adverse Effects
Time Frame: 12 weeks
The study will record any treatment-related adverse effects (e.g., muscle spasm, gout, gastrointestinal symptoms) over 12 weeks to assess overall safety.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bahria University

Investigators

  • Principal Investigator: Fatima Khatoon, MBBS, Bahria University, Islamabad

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2026

Primary Completion (Actual)

March 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

November 20, 2025

First Submitted That Met QC Criteria

November 20, 2025

First Posted (Actual)

December 1, 2025

Study Record Updates

Last Update Posted (Actual)

June 26, 2026

Last Update Submitted That Met QC Criteria

June 23, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BUHS-IRB # 180/25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) from all study participants, including demographic information, lipid profiles (TC, TG, HDL, LDL, VLDL), glycemic parameters (HbA1c, FBS, RBS), creatine kinase, uric acid, and adverse events, will be shared. Data will be fully anonymized to protect participant privacy

IPD Sharing Time Frame

IPD and supporting information will be available after publication of the primary study results and will remain accessible for 3 years following the study completion

IPD Sharing Access Criteria

All data will be accessible to every one

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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