Approval Probability
TA Base Rate
Adjusted LOA
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LY3303560 · 2 trials · 2 indications
A summary of other non-serious adverse events (AEs), and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Number of participants with one or more SAEs considered by the investigator to be related to study drug administration. A summary of other nonserious adverse events (AEs), and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
| Arm | Type | Description |
|---|---|---|
| 70 mg LY3303560 | EXPERIMENTAL | 70 milligram (mg) LY3303560 administered intravenously (IV) every 4 weeks for 25 weeks with the option of continuing treatment up to 49 weeks (up to 6 further doses), followed by a 16-week follow-up period. |
| 210 mg LY3303560 | EXPERIMENTAL | 210 mg LY3303560 administered IV every 4 weeks for 25 weeks with the option of continuing treatment up to 49 weeks (up to 6 further doses), followed by a 16-week follow-up period. |
| Placebo IV | EXPERIMENTAL | Placebo administered intravenously (IV) every 4 weeks for 25 weeks with the option of continuing treatment up to 49 weeks (up to 6 further doses),, followed by a 16-week follow-up period. |
| LY3303560 | EXPERIMENTAL | Single IV infusion 7 milligram (mg), 21 mg, 70 mg, 210 mg, 700 mg, 1400 mg, 2800 mg, and 5600 mg of LY3303560 on Day 1 in healthy participants. |
| Saline Solution | PLACEBO_COMPARATOR | Single IV infusion of saline solution to match LY3303560 on Day 1 in healthy participants. |
| LY3303560 Subcutaneous (SC) | EXPERIMENTAL | Single SC injection of 210 mg LY3303560 on Day 1 in healthy participants. |
| Name | Type | Description |
|---|---|---|
| LY3303560 - IV | DRUG | Administered IV |
| Placebo - IV | DRUG | Administered IV |
| Florbetapir F 18 | DRUG | Administered IV during the Positron Emission Tomography (PET) scan performed during screening. |
| Flortaucipir F18 | DRUG | Administered IV during the PET scan performed during the study. |
| Saline Solution - IV | DRUG | Administered IV |
| LY3303560 - SC | DRUG | Administered SC |
Inclusion Criteria: * Mild Cognitive Impairment (MCI) due to Alzheimer's Disease (AD) or mild-to-moderate AD based on National Institute of Aging and Alzheimer's Association diagnostic criteria * Female participants: women not of child-bearing potential may participate, and include those who are: ...
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LY3303560 is an investigational small molecule being studied for the treatment of Alzheimer's disease. It is being developed by Eli Lilly and Company for patients with Alzheimer's disease, including those with mild cognitive impairment. The drug is currently in Phase 1 clinical development.
LY3303560 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The company is conducting clinical trials to evaluate the drug's safety and tolerability in healthy participants and in participants with Alzheimer's disease.
LY3303560 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. Two Phase 1 trials have been completed, one in healthy participants and participants with Alzheimer's disease, and another in participants with mild cognitive impairment or Alzheimer's disease.
LY3303560 has been studied in two completed Phase 1 clinical trials. The first trial, NCT02754830, enrolled 72 participants in the United States and included healthy volunteers and participants with Alzheimer's disease. The second trial, NCT03019536, enrolled 22 participants in the United States, Japan, and the United Kingdom, and included participants with mild cognitive impairment or Alzheimer's disease.
LY3303560 is the drug name used in clinical trials. No alternative names have been reported for this investigational compound. It is being studied under this identifier in trials sponsored by Eli Lilly and Company for Alzheimer's disease.