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 @ 9:19 PM
Ignite Modification Date:
2025-12-24 @ 9:19 PM
NCT ID:
NCT06894004
Eligibility Criteria:
Inclusion Criteria:
1. age ≥ 18 and \< 40 years
2. BMI ≥ 18.5 and \< 25.0 kg/m2
3. baseline serum LDL-c \< 150 mg/dL (\< 3.9 mmol/L)
4. baseline serum TG \< 100 mg/dL (\< 1.1 mmol/L)
5. HbA1c ≤ 5.6%.
Exclusion Criteria:
1. personal or family history of familial hypercholesterolemia
2. current use of lipid-lowering drugs
3. currently on a ketogenic diet and unwilling to change diet
4. current tobacco use
5. hypertension
6. prediabetes or diabetes
7. elevated Lp(a) \> 6.5% of ApoB-containing lipoproteins at baseline
8. oral contraceptive use
9. contraindication to heparin
10. known atherosclerotic cardiovascular disease
11. unwilling to abstain from alcohol
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
39 Years
Study:
NCT06894004
Study Brief:
Protocol Section:
NCT06894004