Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY2886721 · 3 trials · 3 indications
AUC0-∞ following administration of a single dose of 70 or 280 mg LY2886721.
Cmax following administration of a single dose of 70 or 280 mg LY2886721.
AUC0-∞ following administration of a single dose of 70 mg LY2886721.
Cmax following administration of a single dose of 70 mg LY2886721.
Plasma concentration of Aβ1-40 was summarized based on lowest observed concentration (Cnadir).
Plasma concentration of Aβ1-40 was summarized based on Cnadir following administration of a single dose of 70 mg LY2886721 or a single dose of LY2886721-matching placebo.
Clinically significant effects were defined as serious and nonserious adverse events. A summary of serious and all other nonserious adverse events is located in the Reported Adverse Event module. The number of participants with at least 1 adverse event in each treatment arm is reported for this outcome measure.
A summary of serious adverse events and other nonserious adverse events located in Reported Adverse Event section. To assess effect of food on pharmacokinetics of LY2886721, participants in Cohort B during Period 3 (1 period=8 days) of Part 1 fasted overnight for at least 8 hours prior to receiving a single 7-milligram (mg) oral dose of LY2886721 in the fed state (Part 1 - Fed). Participants in other LY2886721 groups received LY2886721 in fasted state. Due to crossover design in Part 1, results reported by treatment; thus, participants are included in multiple arms.
| Arm | Type | Description |
|---|---|---|
| Cohort A: 70 mg LY2886721 | EXPERIMENTAL | Participants with Alzheimer's disease received a single, 70-milligrams (mg) (1 capsule), oral dose of LY2886721. |
| Cohort A: Placebo | PLACEBO_COMPARATOR | Participants with Alzheimer's disease received a single, oral dose of LY2886721-matching placebo (1 capsule). |
| Cohort B: 70 mg LY2886721 | EXPERIMENTAL | Healthy participants received a single, 70-mg (1 capsule), oral dose of LY2886721. |
| Cohort B: Placebo | PLACEBO_COMPARATOR | Healthy participants received a single, oral dose of LY2886721-matching placebo (1 capsule). |
| Cohort C: 280 mg LY2886721 | EXPERIMENTAL | Healthy participants received a single, 280-mg (4 x 70 mg capsules), oral dose of LY2886721. |
| Cohort C: Placebo | PLACEBO_COMPARATOR | Healthy participants received a single, oral dose of LY2886721-matching placebo (4 capsules). |
| LY2886721 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| LY2886721 Part 1: Cohort A/B | EXPERIMENTAL | Single (7 milligram (mg), 15 mg, 25 mg, 35 mg) doses of LY2886721 administered orally in up to three of three study periods |
| Placebo Part 1: Cohort A/B | PLACEBO_COMPARATOR | Single dose in up to 1 period |
| LY2886721 Part 2: Cohort C | EXPERIMENTAL | Single 10 mg dose of LY2886721, dose determined by Part 1 |
| LY2886721 Part 2: Cohort D | EXPERIMENTAL | Single 35 mg dose of LY2886721, dose determined by Part 1 |
| Placebo Part 2: Cohort C/D | PLACEBO_COMPARATOR | Single dose |
| Name | Type | Description |
|---|---|---|
| LY2886721 | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: * Healthy participants have a body mass index (BMI) of 19 to 32 kilograms per square meter (kg/m\^2), inclusive, at screening. There are no restrictions on BMI in participants diagnosed with Alzheimer's disease. * Healthy participants should not be taking any concomitant medicat...
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LY2886721 is an investigational small molecule developed by Eli Lilly and Company for Alzheimer disease. It was studied in Phase 1 clinical trials, and all three of its trials have been completed. It is not an approved therapy and remains a clinical-stage research compound.
LY2886721 was being evaluated as a treatment for Alzheimer disease. Eli Lilly and Company advanced it through Phase 1 testing in both healthy volunteers and participants diagnosed with Alzheimer disease. No approved use has been established, and development did not progress beyond Phase 1.
LY2886721 is made by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly sponsored all of the clinical trials conducted with the compound, including the single-dose and multiple-dose Phase 1 safety studies.
LY2886721 is in Phase 1. All three of its clinical trials were Phase 1 studies, and all three are completed, with no active trials ongoing. The compound has not advanced to later-stage development.
LY2886721 has been studied in three completed Phase 1 trials: NCT01807026 in healthy participants and participants with Alzheimer disease, NCT01227252 testing multiple doses in healthy subjects, and NCT01133405 testing single doses in healthy subjects. Together these trials enrolled 118 participants.
Yes. The LY2886721 clinical program used randomized, double-blind, placebo-controlled designs. The three Phase 1 trials enrolled a total of 118 participants across sites in the United States, and all three studies have been completed.