Dual vs Triple Lipid-Lowering Therapy in Type 2 Diabetes Mellitus Patients With Elevated LDL Chol… (NCT07255820) | Clinical Trial Compass
RecruitingPhase 4
Dual vs Triple Lipid-Lowering Therapy in Type 2 Diabetes Mellitus Patients With Elevated LDL Cholesterol
Pakistan126 participantsStarted 2026-01-01
Plain-language summary
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.
Who can participate
Age range
35 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Primary outcome: Percent Change in LDL-C From Baseline to 12 Weeks and Proportion of Participants Achieving LDL-C <70 mg/dL