Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Remternetug (Test), Remternetug (IV), Remternetug (SC), LY3372993
Remternetug · 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...
Remternetug is an investigational small molecule being developed by Eli Lilly and Company for Alzheimer's disease. It is designed to target amyloid beta and is currently in Phase 3 clinical development. Remternetug is not yet approved for any indication and remains under study in clinical trials.
Remternetug is being studied as a potential disease-modifying treatment for Alzheimer's disease, including early Alzheimer's disease and early-onset forms linked to genetic mutations. It is investigational and has not been approved for use. Clinical trials are evaluating its effects in participants with or at risk for Alzheimer's disease.
Remternetug targets amyloid beta. By binding to amyloid beta, it is intended to interfere with the amyloid pathway implicated in Alzheimer's disease. This mechanism is being evaluated in clinical trials for its potential to modify disease progression in patients with Alzheimer's disease.
Remternetug is being developed by Eli Lilly and Company, which trades under the ticker LLY. The company is responsible for the clinical development program, including the Phase 3 TRAILRUNNER-ALZ trials and Phase 2 studies in early-onset Alzheimer's disease.
Remternetug is in Phase 3 clinical development. It is investigational and has not been approved by the FDA or any regulatory agency. The Phase 3 program includes the TRAILRUNNER-ALZ 1 and TRAILRUNNER-ALZ 3 trials, while Phase 2 studies are also ongoing in specific Alzheimer's populations.
Remternetug is being evaluated in four clinical trials. These include Phase 3 trials NCT06653153 (TRAILRUNNER-ALZ 3) and NCT05463731 (TRAILRUNNER-ALZ 1), plus Phase 2 trials NCT06647498 and NCT05552157 in early-onset Alzheimer's disease. Total enrollment across these studies is 3,627 participants.
Yes, Remternetug (Test), Remternetug (IV), and Remternetug (SC) are alternative names or formulations referring to the same investigational drug, Remternetug. The IV and SC notations likely indicate intravenous and subcutaneous administration routes being studied. All refer to the amyloid beta-targeting agent developed by Eli Lilly and Company.