NCT07255820CompletedPhase 4
Dual vs Triple Lipid-Lowering Therapy in Type 2 Diabetes Mellitus Patients With Elevated LDL Cholesterol
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
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 126 (actual)
- First submitted
- 20 Nov 2025
- Start date
- 1 Jan 2026
- Primary completion date
- 30 Mar 2026
- Lead sponsor
- Bahria University
- NCT number
- NCT07255820
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 126
- From 1 Jan 2026 to the primary completion date, 30 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current use of other lipid-lowering agents (e.g., fibrates or PCSK9 inhibitors)
Other illness
- Type 1 Diabetes, gestational diabetes
- Uncontrolled hypothyroidism or nephrotic syndrome
- Recent cancer diagnosis (last 6 months)
- Known allergy to any component
Lab values
- HbA1c \>10 % (86 mmol/mol)
- Acute liver disease or ALT/AST levels \> 3× the upper limit of normal
- Renal failure (GFR \< 30 mL/min)
Other
- BMI \> 32
- Pregnancy or lactation
- Statin intolerance with severe adverse effects (e.g., rhabdomyolysis)
Who the study is looking for
- 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
Age in the registry: 35 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Medical Center Coordinator of this site? Confirm its status | Karachi | Pakistan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.