A Study of Remternetug (LY3372993) in Participants With Alzheimer's Disease (TRAILRUNNER-ALZ 1)
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A Study of Remternetug (LY3372993) in Participants With Alzheimer's Disease (TRAILRUNNER-ALZ 1)
ClinicalTrials.gov ID: NCT05463731
Sponsor: Eli Lilly and Company
Information provided by: Eli Lilly and Company (Responsible Party)
Last Update Posted: 2023-10-17
Brief Summary:
The reason for this study is to collect safety and efficacy information regarding the study drug remternetug in participants with early Alzheimer's disease (AD).
Detailed Description:
TRAILRUNNER-ALZ 1 is a Phase 3, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of remternetug in participants with early symptomatic AD. Initially, 600 participants will enrollin the double-blind treatment period. Participants in the double-blind treatment period will receive remternetug or placebo administered via subcutaneous injection or intravenous infusion.
Following the 52-week main study period, participants will continue participation for up to an additional 52 weeks in an extension period. Participants who previously received remternetug will receive placebo and participants who previously received placebo will receive remternetug. Thus, all participants will receive remternetug if they complete the study.
An additional 640 participants with early Alzheimer's disease will be enrolled to an addendum safety cohort. The participants will be administered open label remternetug via subcutaneous injection or intravenous infusion. Participants enrolled into the addendum safety cohort are not eligible for the extension period.
Official Title:
Assessment of Safety, Tolerability, and Efficacy Measured by Amyloid Reduction of LY3372993 in Early Symptomatic Alzheimer's Disease
Intervention / Treatment:
- Drug: Remternetug (IV)
- Drug: Remternetug (SC)
- Drug: Placebo
| Category | Value |
|---|---|
| Study Start (Actual) | 2022-08-01 |
| Primary Completion (Estimated) | 2025-10 |
| Study Completion (Estimated) | 2026-10 |
| Enrollment (Estimated) | 600 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
18467
J1G-MC-LAKC (Other Identifier) (OTHER: Eli Lilly and Company) |