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)
Mechanism and Biochemical Profile
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>).
- Evacetrapib (LY2484595) Solubility in DMSO
- Evacetrapib (LY2484595) Stock Solution
- Evacetrapib (LY2484595) Storage
- Evacetrapib (LY2484595) Stability
- Evacetrapib (LY2484595) Molecular Weight
- Evacetrapib (LY2484595) SMILES
- Evacetrapib (LY2484595) CAS Number
- Evacetrapib (LY2484595) Chemical Structure (2D and 3D)
- Evacetrapib (LY2484595) SDS|MSDS