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NOT YET RECRUITING
NCT07255820
PHASE4

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

Sponsor: Bahria University

View on ClinicalTrials.gov

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

DRUG

Rosuvastatin + Ezetimibe

Group A (Dual therapy 1): Tab Rosuvastatin 20 mg + Tab Ezetimibe 10mg (FDC) orally, once daily for 90 days

DRUG

Bempedoic Acid + Ezetimibe

Group B (Dual therapy 2): Tab Bempedoic Acid 180mg+ Tab Ezetimibe 10mg (FDC) orally, once daily for 90 days

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

Locations (1)

National Medical Center

Karachi, Sindh, Pakistan