Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT07255820
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)
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Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
60 Years
Study:
NCT07255820
Study Brief:
Protocol Section:
NCT07255820