Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Remternetug (SC)
Remternetug · 5 trials · 5 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.
| 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 |
| Remternetug (Test) | EXPERIMENTAL | Remternetug administered subcutaneously (SC) via autoinjector (AI) |
| Remternetug (Reference) | EXPERIMENTAL | Remternetug administered SC via prefilled syringe. |
| 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 |
| Remternetug (Test) | DRUG | Administered SC |
| Remternetug (Reference) | DRUG | Administered 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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Remternetug is an investigational small molecule being developed for Alzheimer's disease. It is being studied in healthy individuals and in people with Alzheimer's disease, including early-onset familial forms caused by genetic mutations. The drug is administered subcutaneously and is currently in Phase 3 clinical trials.
Remternetug is being developed by Eli Lilly and Company, a pharmaceutical company traded on the NYSE under the ticker symbol LLY. The company is conducting multiple clinical trials to evaluate the drug's potential as a disease-modifying treatment for Alzheimer's disease.
Remternetug is in Phase 3 clinical development for Alzheimer's disease. It is not yet approved by regulatory authorities and remains investigational. The drug is being evaluated in the TRAILRUNNER-ALZ 3 study, a Phase 3 trial that is active but not recruiting participants.
Remternetug is being studied in several clinical trials. NCT06653153 is a Phase 3 trial in early Alzheimer's disease with 1,400 participants. NCT05463731 is a completed Phase 3 trial in Alzheimer's disease. NCT05552157 and NCT06647498 are Phase 2 trials in individuals at risk for or with early-onset Alzheimer's caused by genetic mutations.
Yes, Remternetug is also known by the code name LY3372993. Clinical trial records refer to the drug as Remternetug (LY3372993), confirming that these names identify the same investigational compound being developed by Eli Lilly for Alzheimer's disease.
Remternetug is not FDA approved. It is an investigational drug currently in Phase 3 clinical trials for Alzheimer's disease. The drug has not completed the regulatory review process, and its safety and efficacy have not been established for commercial use.