Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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.
Data were collected using a 12-lead electrocardiogram (ECG). The QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle and corrected for heart rate. Population-corrected QT interval (QTcP) formula: QTcP = QT / RR\^ß, where ß is the population correction factor.
The number of participants with 1 or more AEs is summarized cumulatively. In addition, the number of participants with any serious AEs is summarized cumulatively. A serious AE is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.
The geometric least squares (LS) means for the maximum observed plasma concentration (Cmax) of LY2484595 following administration of LY2484595 alone and with ketoconazole are reported. Least squares means were calculated from an analysis of variance (ANOVA) model with a fixed effect for treatment and a random effect for participant. The LS means for each treatment and the 90% confidence intervals (CI) for the difference in means were back transformed from the log scale to provide estimates of the geometric means and 90% CIs for the ratio of the geometric means (LY2484595 coadministered with ketoconazole and LY2484595 alone).
The median times to maximum observed plasma concentration (Tmax) of LY2484595 following administration of LY2484595 alone and with ketoconazole are reported.
The geometric least squares (LS) means of area under the concentration-time curve (AUC) from time zero extrapolated to infinity (AUC0-∞) of LY2484595 following administration of LY2484595 alone and with ketoconazole are reported. Least squares means were calculated from an analysis of variance (ANOVA) model with a fixed effect for treatment and a random effect for participant. The LS means for each treatment and the 90% confidence intervals (CI) for the difference in means were back transformed from the log scale to provide estimates of the geometric means and 90% CIs for the ratio of the geometric means (LY2484595 coadministered with ketoconazole and LY2484595 alone).
Area under the concentration-time curve from time zero to infinity is presented.
| 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 | - |
| 1200 milligrams (mg) LY2484595 | EXPERIMENTAL | Administered orally once daily for 10 days during 1 of the 3 crossover periods, separated by at least a 14-day washout period. |
| 400 mg Moxifloxacin | ACTIVE_COMPARATOR | Positive control, unblinded treatment administered orally once during 1 of 3 crossover periods, separated by at least a 14-day washout period. |
| Part 1 (Cohort A): 100 mg, 1800 mg LY2484595, Placebo | EXPERIMENTAL | Period 1: Participants will receive either 100 milligrams (mg) LY2484595 tablets or placebo tablets once daily (QD) by mouth on Days 1 through 14 of Period 1. Washout period lasting ≥14 days. Period 2: Participants will receive either 1800 mg LY2484595 tablets or placebo tablets QD by mouth on Days 1 through 14 of Period 2. |
| Part 1 (Cohort B): 300 mg LY2484595, Placebo | EXPERIMENTAL | Participants will receive either 300 milligrams (mg) LY2484595 tablets or placebo tablets once daily (QD) by mouth on Days 1 through 14. |
| Part 1 (Cohort C): 600 mg LY2484595, Placebo | EXPERIMENTAL | Participants will receive either 600 milligrams (mg) LY2484595 tablets or placebo tablets once daily (QD) by mouth on Days 1 through 14. |
| Part 1 (Cohort D): 1200 mg LY2484595, Placebo | EXPERIMENTAL | Participants will receive either 1200 milligrams (mg) LY2484595 tablets or placebo tablets once daily (QD) by mouth on Days 1 through 14. |
| Part 2 (Cohort E): 100 mg LY2484595 ± 400 mg Ketoconazole | EXPERIMENTAL | Period 1: Participants will receive 100 milligrams (mg) LY2484595 tablet by mouth on Day 1 of Period 1. Washout period lasting ≥14 days. Period 2: Participants will receive 400 mg ketoconazole tablets once daily (QD) by mouth on Days 1 through 14 of Period 2. Participants will receive 100 mg LY2484595 tablet by mouth on Day 5 of Period 2. |
| Cohort A: Fixed Sequence of Meal Conditions | EXPERIMENTAL | LY2484595 (evacetrapib): 200 milligrams (mg) of LY2484595 administered orally, one time only, as an SDSD-PG tablet given with no food. There was a washout of at least 14 days before crossing over and receiving a 200 mg of LY2484595 administered orally, one time only, as a SDSD-PG tablet given with low-fat breakfast. There was another washout period of at least 14 days before crossing over and receiving a 200 mg of LY2484595 administered orally, one time only, as a SDSD-PG tablet given with high-fat breakfast. |
| Cohort B: Comparison of Randomized Treatments | EXPERIMENTAL | LY2484595 (evacetrapib): 100 mg of LY2484595 administered orally as an RF tablet given with a low-fat breakfast. There was a washout period of at least 14 days before crossing over and receiving 100 mg of LY2484595 administered orally as a SDSD-PG tablet given with a low-fat breakfast. There was another washout of at least 14 days before crossing over and receiving 300 mg of LY2484595 as a SDSD-PG tablet given with a low-fat breakfast. |
| 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 |
| Moxifloxacin | DRUG | Single dose administered orally. |
| Ketoconazole | DRUG | Administered orally |
| LY2484595 Reference Formulation (RF) | DRUG | Administered orally |
| LY2484595 spray-dried solid dispersion-propyl gallate (SDSD-PG) | 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) ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 2 | PHASE3 | Lepodisiran |
| Merck & Co., Inc. | MRK | 1 | PHASE3 | Enlicitide, Rosuvastatin |
| NewAmsterdam Pharma Company N.V. | NAMS | 3 | PHASE3 | obicetrapib, ezetimibe daily |
| AstraZeneca PLC | AZN | 3 | PHASE2 | AZD0780, Rosuvastatin |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 1 | PHASE1 | ARO-DIMERPA |
| Novartis AG Sponsored ADR | NVS | 1 | - | Undisclosed |
| CRISPR Therapeutics AG | CRSP | 1 | PHASE1 | CTX310 |
| HeartFlow, Inc. | HTFL | 1 | N/A | Rosuvastatin |
LY2484595 is an investigational small molecule being studied for dyslipidemia, a condition of abnormal lipid levels in the blood. It has also been evaluated in healthy volunteers and healthy participants to assess its safety and pharmacokinetics. The drug is in clinical development by Eli Lilly and Company for the cardiovascular therapeutic area.
LY2484595 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker LLY. The company has sponsored clinical trials of the drug in the United States and Japan.
LY2484595 has completed Phase 1 and Phase 2 clinical trials. The most advanced study, NCT01375075, was a Phase 2 trial in Japanese subjects with dyslipidemias. All trials listed for LY2484595 are completed, and the drug remains investigational, not approved by regulatory authorities.
LY2484595 has been studied in four completed clinical trials. NCT01375075 was a Phase 2 study in Japanese subjects with dyslipidemias. NCT01448824, NCT01450098, and NCT01537887 were Phase 1 studies in healthy participants or volunteers in the United States, including a trial on the drug's effect on heart electrical activity.
No alternative names for LY2484595 have been disclosed in the clinical trial records. The drug is identified solely by its code name LY2484595 in the studies sponsored by Eli Lilly and Company.