Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY2623091 · 5 trials · 3 indications
Change from baseline in SBP as measured by a cuff. Least squares (LS) mean change from baseline was calculated using a mixed model repeating measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Proteinuria was the presence of excess serum protein in the urine. Proteinuria was calculated for each participant after each treatment period. Change was calculated as (Day 21 post-treatment value) minus (baseline value).
Cumulative percent of radioactive dose recovered in urine and feces after administration at specified intervals.
A summary of serious adverse events and other nonserious adverse events are located in the Reported Adverse Event section.
| Arm | Type | Description |
|---|---|---|
| 6 milligrams (mg) LY2623091 | EXPERIMENTAL | 6 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks. |
| 13 mg LY2623091 | EXPERIMENTAL | 13 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks. |
| 24.5 mg LY2623091 | EXPERIMENTAL | 24.5 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks. |
| 13 mg LY2623091 + 20 mg tadalafil | EXPERIMENTAL | 13 mg LY2623091 and 20 mg of tadalafil with placebo for blinding administered orally once daily for 4 weeks. |
| 20 mg tadalafil | EXPERIMENTAL | 20 mg tadalafil with placebo for blinding administered orally once daily for 4 weeks. |
| Spironolactone | ACTIVE_COMPARATOR | 25 mg titrated to 50 mg as tolerated of spironolactone (open label) administered orally once daily for 4 weeks. |
| Placebo | PLACEBO_COMPARATOR | Placebo for blinding administered orally once daily for 4 weeks. |
| 0.2 milligrams (mg) LY2623091 | EXPERIMENTAL | Daily by mouth for 21 days. Days 1-20 administered in the fed state. Day 21 administered in the fasted state. Minimum wash-out period of 28 days between dosing in treatment periods |
| 1.5 mg LY2623091 | EXPERIMENTAL | Daily by mouth for 21 days. Days 1-20 administered in the fed state. Day 21 administered in the fasted state. Minimum wash-out period of 28 days between dosing in treatment periods |
| 10 mg LY2623091 | EXPERIMENTAL | Daily by mouth for 21 days. Days 1-20 administered in the fed state. Day 21 administered in the fasted state. Minimum wash-out period of 28 days between dosing in treatment periods |
| 50 mg Eplerenone | ACTIVE_COMPARATOR | Daily by mouth for 21 days. Days 1-20 administered in the fed state. Day 21 administered in the fasted state. Minimum wash-out period of 28 days between dosing in treatment periods |
| LY2623091 (Group 1) | EXPERIMENTAL | LY2623091 administered orally once on Day 1 of Period 1. |
| Itraconazole + LY2623091 (Group 1) | EXPERIMENTAL | 200 mg itraconazole administered orally twice daily on Day 1 of Period 2 and once daily on Days 2 - 20 of Period 2. Single oral dose of LY2623091 coadministered on Day 6 of Period 2. |
| Simvastatin (Group 2) | EXPERIMENTAL | 20 mg simvastatin administered orally once daily on Day 1. |
| LY2623091 + Simvastatin (Group 2) | EXPERIMENTAL | LY2623091 administered orally once daily on Days 3 - 13. Single oral dose of 20 mg simvastatin coadministered on Day 12. |
| Tadalafil (Group 3) | EXPERIMENTAL | 5 mg tadalafil administered on Day 1 of Period 1. Arm is contingent on interim results from Groups 1 and 2. |
| Tadalafil + LY2623091 (Group 3) | EXPERIMENTAL | LY2623091 administered orally once daily on Day 1 up to Day 15 of Period 2. 5 mg tadalafil co-administered once daily on Day 10 of Period 2. Arm is contingent on interim results from Groups 1 and 2. |
| LY2623091 (Group 4) | EXPERIMENTAL | LY2623091 administered orally once on Day 1 of Period 1. Arm is contingent on interim results from Groups 1 and 2. |
| Diltiazem + LY2623091 (Group 4) | EXPERIMENTAL | 240 mg diltiazem administered once daily on Days 1 to 13 of Period 2. Single oral dose of LY2623091 coadministered on Day 4 of Period 2. Arm is contingent on interim results from Groups 1 and 2. |
| LY2623091 | EXPERIMENTAL | Single oral dose of LY2623091 |
| 1 mg LY2623091 | EXPERIMENTAL | Daily by mouth for 7 days. |
| 25 mg LY2623091 | EXPERIMENTAL | The anticipated dose of LY2623091 was revised down from the original proposed dose level of 100 mg based on safety and tolerability data. The 25 mg LY2623091 was administered daily by mouth for 7 days. |
| 0.3 mg LY2623091 | EXPERIMENTAL | The anticipated dose of LY2623091 was revised down from the original proposed dose level of up to 200 mg. The 0.3 mg LY2623091 was determined based on an interim analysis after the third dose level and was administered daily by mouth for 7 days. |
| Name | Type | Description |
|---|---|---|
| LY2623091 | DRUG | Administered orally |
| Tadalafil | DRUG | Administered orally |
| Spironolactone | DRUG | Administered orally |
| Placebo | DRUG | Administered orally |
| Eplerenone | DRUG | Administered orally |
| Itraconazole | DRUG | Administered orally |
| Simvastatin | DRUG | Administered orally |
| Diltiazem | DRUG | Administered orally |
Inclusion Criteria: * Have a history of hypertension. * If participants are naïve to treatment of hypertension, or have not been treated with any antihypertensive medications within the 30 days immediately prior to screening: * Have seated systolic (SBP) of ≥140 and \<170 millimeters of mercury ...
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LY2623091 is an investigational small molecule being studied for primary hypertension and chronic kidney disease. Clinical trials have also included healthy volunteers to assess safety and tolerability. It is not approved and remains in clinical development.
LY2623091 is being developed by Eli Lilly and Company, traded on the New York Stock Exchange under the ticker LLY. The company has sponsored clinical trials of the drug in hypertension and chronic kidney disease.
LY2623091 is in Phase 2 clinical development. Completed trials include Phase 1 and Phase 2 studies in chronic kidney disease, hypertension, and healthy volunteers. The drug is investigational and has not been approved by regulatory authorities.
LY2623091 has been studied in four completed trials. NCT01237899 and NCT02300259 were Phase 1 studies in healthy volunteers and chronic kidney disease. NCT01427972 was a Phase 2 study in chronic kidney disease, and NCT02194465 was a Phase 2 study in primary hypertension.
LY2623091 has been studied in chronic kidney disease to evaluate its safety, tolerability, pharmacokinetics, and effect on renal potassium clearance. A Phase 2 trial enrolled 42 participants with chronic kidney disease in Bulgaria and South Africa.
No alternative names for LY2623091 have been disclosed. The drug is identified solely by its code name LY2623091 in clinical trial records and development documentation.