NCT07255820 Dual vs Triple Lipid-Lowering Therapy in Type 2 Diabetes Mellitus Patients With Elevated LDL Cholesterol
| NCT ID | NCT07255820 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Bahria University |
| Condition | Type 2 Diabetes Mellitus |
| Study Type | INTERVENTIONAL |
| Enrollment | 126 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2026-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 126 participants in total. It began in 2026-01-01 with a primary completion date of 2026-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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)
Contact & Investigator
Fatima Khatoon, MBBS
PRINCIPAL INVESTIGATOR
Bahria University, Islamabad
Frequently Asked Questions
Who can join the NCT07255820 clinical trial?
This trial is open to participants of all sexes, aged 35 Years or older, up to 60 Years, studying Type 2 Diabetes Mellitus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07255820 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07255820 currently recruiting?
Yes, NCT07255820 is actively recruiting participants. Contact the research team at fatima.omair@gmail.com for enrollment information.
Where is the NCT07255820 trial being conducted?
This trial is being conducted at Karachi, Pakistan.
Who is sponsoring the NCT07255820 clinical trial?
NCT07255820 is sponsored by Bahria University. The principal investigator is Fatima Khatoon, MBBS at Bahria University, Islamabad. The trial plans to enroll 126 participants.
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