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:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2025-12-24 @ 3:07 PM
NCT ID:
NCT03344692
Eligibility Criteria:
Inclusion Criteria:
* Men with type 2 diabetes diagnosed since ≥ 6 months
* HbA1C \<9.0%
* Men with primary hypercholesterolemia and/or mixed dyslipidemia
* Aged 18-75 years (limits inclusive)
* Patient could be treated for type 2 diabetes when diet and physical activity are not sufficient to restore glycemic control. The treatment must be stable 1 month before the inclusion and have to remain unchanged all along the study. The only authorized treatments are:
* Metformin
* And/or Sulphonylureas (SUs)
* And/or Repaglinide
* And/or DPP-4 inhibitors
* And/or GLP1 receptor agonists: exenatide, liraglutide, dulaglutide
* Fasting serum TG ≥ 150 mg/dl and \< 500 mg/dl
* BMI: 20-45 kg/m2
* Use of statins or ezetimibe is allowed if treatment is stable for ≥ 1 month before the screening
Exclusion Criteria:
* Any secondary causes of hypercholesterolemia or of mixed dyslipidemia (nephrotic syndrome, hypothyroidism…)
* impaired liver function (AST and/or ALT ≥ 3ULN)
* impaired renal function (eGFR with CKD-EPI formula \< 30 ml/min)
* Alcohol abuse (\> 2 standard alcoholic drink per day; 1 standard alcoholic drink is the equivalent of 10g of alcohol)
* History of myocardial infarction, acute coronary syndrome, unstable angina pectoris, stroke, transient ischemic attack, or cardiac revascularization within the 6 months before the screening visit.
* History of PCSK9 mAb use
* Known sensitivity to monoclonal antibody therapeutics or to their excipients
* Lipid lowering therapies (other than statins), including fibrates, omega-3 fatty acids, bile acid sequestrants, niacin.
* Insulin-treated patients
* History of bariatric surgery
* Inflammatory bowel diseases and gastrointestinal malabsorption diseases
* Uncontrolled hypothyroidism (TSH \> ULN and Free T4 \< ULN) or hyperthyroidism (TSH \< ULN)
* Active cancer: progressive cancer or remission ≤ 3 years, except for basal or squamous cell carcinoma of the skin that has been successfully treated
* Known history of positive test for HIV, hepatitis C or chronic hepatitis B
* Corticosteroids therapy
* Minors
* Adults under guardianship or trusteeship
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03344692
Study Brief:
Protocol Section:
NCT03344692