Clinical Trials

Sponsored by Eli Lilly and Company, numerous clinical trials spanning Phase 1, Phase 2, and Phase 3 have evaluated evacetrapib across conditions including dyslipidemia, hypercholesterolemia, hyperlipidemia, hepatic insufficiency, and cardiovascular disease, alongside pharmacokinetic and bioequivalence evaluations. While several studies assessing bioequivalence and pharmacokinetics have been completed, other trials within the program were terminated. Together, these evaluations characterize the compound's pharmacokinetic behavior, drug interaction potential, and therapeutic profile in populations affected by metabolic and cardiovascular conditions.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01687998 TERMINATED
Cardiovascular Diseases
Eli Lilly and Company
2012-10 PHASE3
NCT02227784 TERMINATED
Hyperlipidemia
Eli Lilly and Company
2014-10 PHASE3
NCT02168803 COMPLETED
Dyslipidemia
Eli Lilly and Company
2014-05 PHASE1
NCT02497391 COMPLETED
Healthy
Eli Lilly and Company
2015-07 PHASE1
NCT02260648 TERMINATED
Hypercholesterolemia
Eli Lilly and Company
2015-01 PHASE3
NCT02497391 Completed
Healthy
Eli Lilly and Company
2015-07 Phase 1
NCT02260635 TERMINATED
Hypercholesterolemia
Eli Lilly and Company
2014-11 PHASE3
NCT02226653 COMPLETED
Healthy Volunteers
Eli Lilly and Company
2014-09 PHASE1
NCT02365558 COMPLETED
Healthy
Eli Lilly and Company
2015-01 PHASE1
NCT02365558 Completed
Healthy
Eli Lilly and Company
2015-01 Phase 1
NCT02156492 COMPLETED
Healthy Volunteers
Eli Lilly and Company
2014-06 PHASE1
NCT02271425 COMPLETED
Healthy Volunteers
Eli Lilly and Company
2014-10 PHASE1
NCT02271425 Completed
Healthy Volunteers
Eli Lilly and Company
2014-10 Phase 1
NCT02226653 Completed
Healthy Volunteers
Eli Lilly and Company
2014-09 Phase 1
NCT02161731 COMPLETED
Healthy Volunteers
Eli Lilly and Company
2014-06 PHASE1
NCT02156492 Completed
Healthy Volunteers
Eli Lilly and Company
2014-06 Phase 1
NCT02168803 Completed
Dyslipidemia
Eli Lilly and Company
2014-05 Phase 1
NCT01958489 COMPLETED
Healthy Volunteers
Eli Lilly and Company
2013-10 PHASE1
NCT01903434 COMPLETED
Healthy Volunteers
Eli Lilly and Company
2013-07 PHASE1
NCT01836185 COMPLETED
Hepatic Insufficiency
Eli Lilly and Company
2013-04 PHASE1
NCT01825889 COMPLETED
Cardiovascular Disease
Eli Lilly and Company
2013-04 PHASE1
NCT01908582 COMPLETED
Healthy Volunteers
Eli Lilly and Company
2013-07 PHASE1
NCT01897493 COMPLETED
Healthy Volunteers
Eli Lilly and Company
2013-07 PHASE1
NCT01810432 COMPLETED
Healthy Volunteers
Eli Lilly and Company
2013-03 PHASE1
NCT01825876 COMPLETED
Healthy Volunteers
Eli Lilly and Company
2013-04 PHASE1
NCT01746732 COMPLETED
Healthy Volunteers
Eli Lilly and Company
2012-12 PHASE1
NCT01736254 COMPLETED
Healthy Volunteers
Eli Lilly and Company
2012-12 PHASE1
NCT01537887 COMPLETED
Healthy Volunteers
Eli Lilly and Company
2012-02 PHASE1
NCT01375075 COMPLETED
Dyslipidemias
Eli Lilly and Company
2011-06 PHASE2
NCT01448824 COMPLETED
Healthy Participants
Eli Lilly and Company
2011-10 PHASE1
NCT01450098 COMPLETED
Healthy Volunteers
Eli Lilly and Company
2011-10 PHASE1
NCT01105975 COMPLETED
Dyslipidemia
Eli Lilly and Company
2010-04 PHASE2

(data from https://clinicaltrials.gov, updated on 2019-10-08)

Check the Evacetrapib (LY2484595) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Evacetrapib selectively binds to and inhibits cholesteryl ester transfer protein (CETP) with an IC50 of 5.5 nM, thereby blocking the neutral lipid transfer of cholesteryl esters from high-density lipoproteins to pro-atherogenic low-density lipoproteins. By elevating circulating high-density lipoprotein cholesterol levels without triggering aldosterone release or raising blood pressure, this target inhibition offers a mechanistic basis for managing dyslipidemia, hypercholesterolemia, and cardiovascular disease.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Note: Technical data last updated: Sep 1, 2026.