Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY3045697 · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| LY3045697 | EXPERIMENTAL | Escalating dose (0.1 milligrams \[mg\] up to 100 mg) of LY3045697 administered once daily, orally, for 8 days in 2 of 3 dosing periods |
| Spironolactone | ACTIVE_COMPARATOR | 25 mg spironolactone administered once daily, orally, for 8 days in up to 1 of 3 dosing periods |
| Placebo | PLACEBO_COMPARATOR | Placebo matching LY3045697 administered once daily, orally for 8 days in up to 1 of 3 dosing periods |
| Group 1 | EXPERIMENTAL | Period 1: 0.1 milligrams (mg) LY3045697 administered once orally or matching placebo administered once orally. Period 2: 1 mg LY3045697 administered once orally or matching placebo administered once orally. Period 3: 10 mg LY3045697 administered once orally or matching placebo administered once orally. |
| Group 2 | EXPERIMENTAL | Period 1: 0.3 mg LY3045697 administered once orally or matching placebo administered once orally. Period 2: 3 mg LY3045697 administered once orally or matching placebo administered once orally. Period 3: 30 mg LY3045697 administered once orally or matching placebo administered once orally. |
| Group 3 | EXPERIMENTAL | Period 1: 100 mg of LY3045697 administered once orally or matching placebo administered once orally. Period 2: 300 mg of LY3045697 administered once orally or matching placebo administered once orally (via split delivery over a 15-minute period). |
| Name | Type | Description |
|---|---|---|
| LY3045697 | DRUG | Administered as oral solution |
| Placebo | DRUG | Administered as oral solution |
| Spironolactone | DRUG | Administered as capsule |
Inclusion Criteria: * Healthy men and women of non-child bearing potential as determined by medical history and physical examination * Male participants must agree to use a medically accepted method of contraception with all sexual partners during the study and for 90 days after the end of the fina...
LY3045697 is an investigational small molecule being developed by Eli Lilly and Company. It is currently in Phase 1 clinical development, studied in healthy volunteers. Two Phase 1 trials have been completed, with a total enrollment of 51 participants. The drug is not yet approved and remains in clinical testing.
LY3045697 is being studied for use in healthy volunteers, as part of early-phase clinical development. The completed trials focused on evaluating the drug in healthy participants, with no specific disease indication targeted. Its intended therapeutic use has not been established beyond this initial testing phase.
LY3045697 is developed by Eli Lilly and Company, a pharmaceutical company listed on the stock exchange under the ticker LLY. Eli Lilly is responsible for the clinical development of this investigational small molecule drug.
LY3045697 is in Phase 1 clinical development. Two Phase 1 trials have been completed, both in healthy volunteers. The drug is investigational and has not been approved by regulatory authorities. It remains in early-stage clinical testing.
LY3045697 has been studied in two completed Phase 1 trials: NCT01750853, a study in healthy participants with 27 enrolled, and NCT01821703, a multiple oral dosing study in healthy participants with 24 enrolled. Both trials were conducted in the Netherlands and are now completed.
LY3045697 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trials were early-phase studies in healthy volunteers, and the drug has not yet been evaluated for approval by regulatory agencies.