Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Remternetug (Test), Remternetug (Reference), Remternetug (IV), Remternetug (SC), Remternetug
LY3372993 · 6 trials · 6 indications
Time to clinically meaningful progression as measured by CDR. CDR is a clinician-rated scale that provides an overall assessment of the participant's stage and degree of impairment across the continuum of early Alzheimer's Disease (AD).
Defined in each drug-specific appendix; will be an assessment of biomarkers of early-stage disease (e.g., amyloid PET, soluble amyloid, soluble phospho-tau) compared with baseline in each treatment group
If applicable, will be defined in each drug-specific appendix, and will be an assessment of the change in progression of biomarkers representing tau, neurodegenerative, and inflammatory pathobiological events in the disease cascade for temporally different periods of the pre-symptomatic phases of the disease.
CL calculated using \[11C\] PiB PET non-partial volume corrected (regional spread function) standardized uptake value ratio cortical composite (PiB PET SUVR) is the primary outcome and change from baseline at 2 years is the primary endpoint.
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
| Arm | Type | Description |
|---|---|---|
| Remternetug | EXPERIMENTAL | Remternetug administered subcutaneously (SC). |
| Placebo | PLACEBO_COMPARATOR | Placebo administered SC. |
| Remternetug (IV) | EXPERIMENTAL | Participants will receive remternetug intravenously (IV) Participants will receive remternetug IV during the treatment period, then switch to placebo IV in the extension period. |
| Remternetug (SC) | EXPERIMENTAL | Participants will receive one of two dosing regimens of remternetug subcutaneously (SC) Participants will receive remternetug SC during the treatment period, then switch to placebo SC in the extension period. |
| Open-Label Addenda Remternetug (IV) | EXPERIMENTAL | Participants will receive one of six dosing regimens of remternetug IV during the open-label addenda. |
| Open-Label Addenda Remternetug (SC) | EXPERIMENTAL | Participants will receive one of nine dosing regimens of remternetug SC during the open-label addenda. |
| Stage 1: Remternetug | EXPERIMENTAL | Active Remternetug- blinded |
| Stage 1: Matching Placebo (Remternetug) | PLACEBO_COMPARATOR | Matching placebo |
| Stage 2: Remternetug Open Label | ACTIVE_COMPARATOR | Open label will start after last dose of Stage 1 |
| LY3372993 (Part A) | EXPERIMENTAL | LY3372993 administered as multiple doses either intravenously (IV) or subcutaneously (SC). |
| LY3372993 (Part B) | EXPERIMENTAL | LY3372993 administered as single dose IV or SC. |
| Placebo (Part A) | PLACEBO_COMPARATOR | Placebo administered as multiple doses IV or SC. |
| Placebo (Part B) | PLACEBO_COMPARATOR | Placebo administered as single dose IV or SC. |
| Name | Type | Description |
|---|---|---|
| Remternetug | DRUG | Administered SC |
| Placebo | DRUG | Administered SC |
| Remternetug (IV) | DRUG | Administered IV |
| Remternetug (SC) | DRUG | Administered SC |
| Matching Placebo (Remternetug) | DRUG | Administered as subcutaneous injection of placebo every 12 weeks |
| LY3372993 | DRUG | Administered IV or SC. |
Inclusion Criteria: * Have a phosphorylated tau (P-tau) result consistent with the presence of amyloid pathology. * Have a reliable study partner and backup study partner familiar with overall function and behavior, such as day-to-day activities and cognitive abilities. * Have adequate literacy, vi...
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LY3372993 is an investigational small molecule being developed by Eli Lilly and Company for Alzheimer disease. It has been studied in Phase 1 clinical trials involving both healthy participants and participants with Alzheimer disease. It is not approved and remains in clinical development.
LY3372993 is being evaluated as a potential treatment for Alzheimer disease. The clinical program enrolled participants with Alzheimer disease alongside healthy volunteers to assess the drug in Phase 1 studies. No approved use has been established, and the compound remains investigational.
LY3372993 is being developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly sponsored both Phase 1 trials of the compound, conducted in the United States and Japan.
LY3372993 is in Phase 1 development. Two Phase 1 trials have been completed, and no active trials are currently listed. The studies together enrolled 175 participants and were randomized, double-blind, and placebo-controlled.
LY3372993 has been studied in two completed Phase 1 trials: NCT04451408, which enrolled 139 participants with Alzheimer disease and healthy participants in the United States and Japan, and NCT03720548, which enrolled 36 healthy participants and participants with Alzheimer disease in the United States.