Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06653153 | A Study of Remternetug (LY3372993) in Early Alzheimer's Disease (TRAILRUNNER-ALZ 3) | PHASE3 | ACTIVE NOT_RECRUITING | 1,400 | — | — | Oct 24, 2024 | Oct 1, 2030 | Nov 20, 2025 | 262 | United States, Australia +8 |
| NCT05463731 | A Study of Remternetug (LY3372993) in Participants With Alzheimer's Disease (TRAILRUNNER-ALZ 1) | PHASE3 | COMPLETED | 1,667 | — | — | Aug 1, 2022 | May 12, 2026 | May 22, 2026 | 76 | United States, Japan |
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).
| 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. |
| Name | Type | Description |
|---|---|---|
| Remternetug | DRUG | Administered SC |
| Placebo | DRUG | Administered SC |
| Remternetug (IV) | DRUG | Administered IV |
| Remternetug (SC) | 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...