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Compares treatment options for Type 2 Diabetes Mellitus
Official title Dual vs Triple Lipid-Lowering Therapy in Type 2 Diabetes Mellitus Patients With Elevated LDL Cholesterol
ClinicalTrials.gov ID: NCT07255820
What this study is testing
What is Rosuvastatin + Ezetimibe?
Rosuvastatin + Ezetimibe is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for type 2 diabetes mellitus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 35 to 60
You may be able to join if
- 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
You likely can't join if
- 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)
See the full eligibility 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Karachi, Sindh, Pakistan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 35 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Karachi, Sindh, Pakistan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.