Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as LY2484595 Reference Formulation (RF), LY2484595 Reference Formulation, Evacetrapib, Evacetrapib Tablet, Evacetrapib Intravenous
LY2484595 · 5 trials · 4 indications
Percent change from baseline = 100\*(post-baseline assessment - baseline assessment)/baseline assessment. Higher values in the percent change from baseline represented an improvement for HDL-C and lower values in the percent change from baseline represented an improvement for LDL-C. Least Squares (LS) mean was adjusted for baseline value of the variable analyzed.
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
tlast is defined as the last time point with a measurable concentration of Evacetrapib.
| Arm | Type | Description |
|---|---|---|
| 30 milligrams (mg) LY2484595 | EXPERIMENTAL | Administered orally once daily for 12 weeks |
| 100 mg LY2484595 | EXPERIMENTAL | Administered orally once daily for 12 weeks |
| 500 mg LY2484595 | EXPERIMENTAL | Administered orally once daily for 12 weeks |
| Placebo | PLACEBO_COMPARATOR | Administered orally once daily for 12 weeks |
| 10 mg Atorvastatin | ACTIVE_COMPARATOR | Administered orally once daily for 12 weeks |
| 100 mg LY2484595 + 10 mg Atorvastatin | EXPERIMENTAL | Administered orally once daily for 12 weeks |
| 30 milligram (mg) LY2484595 monotherapy | EXPERIMENTAL | - |
| 100 mg LY2484595 monotherapy | EXPERIMENTAL | - |
| 500 mg LY2484595 monotherapy | EXPERIMENTAL | - |
| 20 mg Atorvastatin monotherapy | ACTIVE_COMPARATOR | - |
| 100 mg LY2484595 + 20 mg Atorvastatin | EXPERIMENTAL | - |
| 40 mg Simvastatin monotherapy | ACTIVE_COMPARATOR | - |
| 100 mg LY2484595 + 40 mg Simvastatin | EXPERIMENTAL | - |
| 10 mg Rosuvastatin monotherapy | ACTIVE_COMPARATOR | - |
| 100 mg LY2484595 + 10 mg Rosuvastatin | EXPERIMENTAL | - |
| Evacetrapib: Single Dose | EXPERIMENTAL | Single oral dose of evacetrapib on Day 1 |
| Evacetrapib: Multiple Dose 12 Weeks | EXPERIMENTAL | Evacetrapib administered orally once daily beginning on Day 8 for 12 consecutive weeks |
| Evacetrapib: Multiple Dose 24 Weeks | EXPERIMENTAL | Evacetrapib administered orally once daily beginning on Day 8 for 24 consecutive weeks |
| Evacetrapib: Multiple Dose 52 Weeks | EXPERIMENTAL | Evacetrapib administered orally once daily beginning on Day 8 for 52 consecutive weeks |
| Evacetrapib (Participants With Renal Impairment) | EXPERIMENTAL | Single oral dose of 130 milligrams (mg) evacetrapib on Day 1 to participants with severe renal impairment. |
| Evacetrapib (Healthy Participants) | EXPERIMENTAL | Single oral dose of 130 mg evacetrapib on Day 1 to participants with normal renal function. |
| Evacetrapib (Healthy) | EXPERIMENTAL | Group 1: 130 milligrams (mg) evacetrapib administered once, orally, to participants with normal hepatic function |
| Evacetrapib (Hepatic, Mild) | EXPERIMENTAL | Group 2: 130 mg evacetrapib administered once, orally, to participants with mild hepatic impairment |
| Evacetrapib (Hepatic, Moderate) | EXPERIMENTAL | Group 3: 130 mg evacetrapib administered once, orally, to participants with moderate hepatic impairment |
| Evacetrapib (Hepatic, Severe) | EXPERIMENTAL | Group 4: 130 mg evacetrapib administered once, orally, to participants with severe hepatic impairment |
| Name | Type | Description |
|---|---|---|
| LY2484595 | DRUG | Administered orally |
| Placebo | DRUG | Administered orally |
| Atorvastatin | DRUG | Administered orally |
| Simvastatin | DRUG | Administered daily by mouth for 12 weeks |
| Rosuvastatin | DRUG | Administered daily by mouth for 12 weeks |
| Placebo for LY2484595 | DRUG | Administered daily by mouth for 12 weeks |
| Placebo for Statins | DRUG | Administered daily by mouth for 12 weeks |
| Evacetrapib | DRUG | Administered orally |
Inclusion Criteria: Have Low HDL-C or High LDL-C criteria as follows: Low HDL lipid criteria: * HDL-C \<45 milligrams per deciliter (mg/dL) (men) and \<50 mg/dL (women), and * LDL-C according to Japan Atherosclerosis Society (JAS) guidelines as follows: * LDL-C \<190 mg/dL (0-1 risk factors) ...
Top 7 of 10 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE3 | Enlicitide |
| Eli Lilly and Company | LLY | 2 | PHASE3 | Lepodisiran, Muvalaplin |
| Novartis AG Sponsored ADR | NVS | 2 | PHASE3 | Pelacarsen |
| NewAmsterdam Pharma Company N.V. | NAMS | 3 | PHASE3 | Obicetrapib |
| AstraZeneca PLC | AZN | 2 | PHASE2 | Rosuvastatin, AZD0780, AZD4954 |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 1 | PHASE1 | ARO-DIMERPA |
| CRISPR Therapeutics AG | CRSP | 1 | PHASE1 | CTX310 |
LY2484595 is an investigational small molecule being studied for dyslipidemia, a condition involving abnormal cholesterol or lipid levels in the blood. Eli Lilly and Company developed it for patients with high LDL cholesterol or low HDL cholesterol. It has been tested in Phase 2 clinical trials but is not described as approved for any use.
LY2484595 is developed by Eli Lilly and Company, which trades under the ticker LLY. The company sponsored both Phase 2 clinical trials of the drug in dyslipidemia, one in Japanese subjects and one in patients with high LDL-C or low HDL-C.
LY2484595 has completed Phase 2 clinical development. Two Phase 2 trials have been conducted, both now completed, with no active trials ongoing. The drug is investigational and has not been described as approved by the FDA for dyslipidemia or any other indication.
LY2484595 was studied in two completed Phase 2 trials. NCT01105975 enrolled 398 patients with high LDL-C or low HDL-C across the United States, Denmark, Germany, Netherlands, Poland, and the United Kingdom. NCT01375075 enrolled 165 Japanese subjects with dyslipidemias in Japan. Both were randomized, double-blind, and placebo-controlled.
Yes. LY2484595 is also known as LY2484595 Reference Formulation, sometimes abbreviated as LY2484595 Reference Formulation (RF). These names refer to the same Eli Lilly and Company investigational small molecule studied in Phase 2 trials for dyslipidemia.
The two completed Phase 2 trials of LY2484595 enrolled a total of 563 patients. NCT01105975 enrolled 398 patients with high LDL-C or low HDL-C, and NCT01375075 enrolled 165 Japanese subjects with dyslipidemias. Both studies used randomized, double-blind, placebo-controlled designs.