Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Mineralocorticoid Receptor Antagonist
LY2623091 · 3 trials · 2 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).
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 |
| 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 |
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 chronic kidney disease and primary hypertension. It has been tested in Phase 2 clinical trials in adults with high blood pressure and in adults with chronic kidney disease. It is not approved for any indication and remains in clinical development.
LY2623091 targets NR3C2, the mineralocorticoid receptor. It acts as an antagonist, meaning it blocks this receptor. NR3C2 antagonism is the mechanism under study for its effects in chronic kidney disease and primary hypertension.
LY2623091 is developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly is the sponsor of the clinical trials studying the compound in chronic kidney disease and primary hypertension.
LY2623091 is in Phase 2 development. Two Phase 2 trials have been completed, one in primary hypertension and one in chronic kidney disease, along with a Phase 1 multiple dose study. No Phase 3 trials have been reported, and the drug is not FDA approved.
Completed trials include NCT02194465, a Phase 2 study of LY2623091 in 304 participants with high blood pressure across the United States, Canada, and Puerto Rico, and NCT01427972, a Phase 2 study in 42 participants with chronic kidney disease in Bulgaria and South Africa. NCT01237899 was a Phase 1 multiple dose study in the Netherlands.
Across the reported studies, 378 participants were enrolled. The Phase 2 hypertension trial NCT02194465 enrolled 304 participants, the Phase 2 chronic kidney disease trial NCT01427972 enrolled 42, and the Phase 1 study NCT01237899 enrolled 32. The Phase 2 trials were randomized, double blind, and placebo controlled.