Screening potential subjects for enrollment in dyslipidemia therapy clinical trials

A method of screening a potential subject for enrollment in a clinical trial testing safety or efficacy, or both, of a candidate dyslipidemia management agent for atherosclerotic cardiovascular disease, the method comprising:

• receiving non-invasively obtained data related to a plaque from the potential subject;
• accessing a systems biology model of atherosclerotic cardiovascular disease;
• modifying the systems biology model using personalized pathway activation data or personalized molecule levels, or both, derived from the non-invasively obtained data from the potential subject to generate a subject-specific systems biology model;
• updating the subject-specific systems biology model with predicted pathway activation data or predicted molecule levels, or both, derived from information relating to an effect on one or more lipoproteins by a candidate dyslipidemia management agent based on a known mechanism of action of the candidate dyslipidemia management agent;
• simulating a therapeutic response by the potential subject to the candidate dyslipidemia management agent in the updated subject-specific systems biology model to obtain a simulated therapeutic effect;
• comparing the updated subject-specific systems biology model with and without the simulated therapeutic response;
• and
• providing a report indicating whether the potential subject's atherosclerotic cardiovascular disease would likely be improved or unaffected by the candidate dyslipidemia management agent, or whether the potential subject would suffer an adverse effect from the candidate dyslipidemia management agent, or both.