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Also known as LY3303560 - IV, Zagotenemab
LY3303560 · 3 trials · 3 indications
Integrated Alzheimer's Disease Rating Scale (iADRS) is a simple linear combination of scores from 13-item alzheimer's disease assessment scale-cognitive subscale (ADAS-Cog13) and the Alzheimer's disease cooperative study-instrumental activities of daily living scale (ADCS-iADL). It is used to assess whether zagotenemab slows down the cognitive and functional decline associated with early symptomatic Alzheimer's Disease, compared to placebo. The iADRS score ranges from 0 to 144 with lower scores indicating worse performance and higher score better performance. Change from baseline was calculated using Bayesian disease progression model (DPM) with fixed, categorical effects of treatment, pooled site, acetylcholinesterase inhibitor (AChEI) use at baseline (yes/no), and the continuous effects of baseline score and age at baseline. Data presented are posterior mean with 95% credible interval.
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 |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants received intravenous (IV) infusion of placebo once every four weeks (Q4W) for 100 weeks. |
| Zagotenemab 1400 mg | EXPERIMENTAL | Participants received IV infusion of 1400 milligram (mg) zagotenemab Q4W for 100 weeks. |
| Zagotenemab 5600 mg | EXPERIMENTAL | Participants received IV infusion of 5600 mg zagotenemab Q4W for 100 weeks. |
| 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 |
|---|---|---|
| Zagotenemab | DRUG | Administered IV |
| Placebo | DRUG | Administered IV |
| 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: * Participants must have gradual and progressive change in memory function for \>6 months. * Participants must have a family member or close friend who is with you at least 10 hours per week and can attend study appointments. Exclusion Criteria: * Participants must not have si...
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LY3303560 is an investigational small molecule being studied for Alzheimer's disease. Eli Lilly and Company developed it for research in participants with mild cognitive impairment or Alzheimer's disease, as well as in healthy volunteers. It is not an approved treatment and remains in clinical development.
LY3303560 is made by Eli Lilly and Company, which trades under the ticker LLY. Lilly is the developer of the asset and sponsored the Phase 1 clinical studies that evaluated it in Alzheimer's disease and in healthy participants.
LY3303560 is in Phase 1. Both of its clinical trials were Phase 1 studies, and both are now completed. The drug is investigational and has not been approved for any indication.
LY3303560 was studied in two completed Phase 1 trials: NCT03019536, which enrolled 22 participants with mild cognitive impairment or Alzheimer's disease across the United States, Japan, and the United Kingdom, and NCT02754830, which enrolled 72 healthy participants and participants with Alzheimer's disease in the United States.
Yes, LY3303560 - IV is an alternative name for LY3303560. Both names refer to the same Eli Lilly and Company investigational small molecule studied in Alzheimer's disease, so searches using either name point to the same drug asset.
The two completed Phase 1 trials of LY3303560 enrolled 94 participants in total. NCT03019536 enrolled 22 participants with mild cognitive impairment or Alzheimer's disease, and NCT02754830 enrolled 72 healthy participants and participants with Alzheimer's disease. Both studies were randomized, double-blind, and placebo-controlled.