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Dual vs Triple Lipid-Lowering Therapy in Type 2 Diabetes Mellitus Patients With Elevated LDL Cholesterol
Sponsor: Bahria University
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.
Official title: 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
Key Details
Gender
All
Age Range
35 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
126
Start Date
2026-01-01
Completion Date
2026-06-30
Last Updated
2025-12-01
Healthy Volunteers
No
Interventions
Rosuvastatin + Ezetimibe
Group A (Dual therapy 1): Tab Rosuvastatin 20 mg + Tab Ezetimibe 10mg (FDC) orally, once daily for 90 days
Bempedoic Acid + Ezetimibe
Group B (Dual therapy 2): Tab Bempedoic Acid 180mg+ Tab Ezetimibe 10mg (FDC) orally, once daily for 90 days
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
Locations (1)
National Medical Center
Karachi, Sindh, Pakistan