A Phase 3 interventional study of Remternetug (IV) and Remternetug (SC) in Alzheimer's Disease, sponsored by Eli Lilly and Company. Completed at 76 sites in 2 countries. Open to participants aged 60 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment
The reason for this study is to collect safety and efficacy information regarding the study drug remternetug in participants with early symptomatic Alzheimer's disease (AD).
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 enroll in 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 76 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 974 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.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's enrollment of 1,667 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.
Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive remternetug intravenously (IV) Participants will receive remternetug IV during the treatment period, then switch to placebo IV in the extension period.
Drug: Remternetug (IV)
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.
Drug: Remternetug (SC)
Participants will receive placebo matching remternetug IV or SC. Participants will receive placebo IV during the treatment period, then switch to remternetug IV in the extension period. Participants will receive placebo SC during the treatment period, then switch to LY3372993 SC in the extension period.
Drug: Placebo
Participants will receive one of six dosing regimens of remternetug IV during the open-label addenda.
Drug: Remternetug (IV)
Participants will receive one of nine dosing regimens of remternetug SC during the open-label addenda.
Drug: Remternetug (SC)
Administered IV
Also known as: LY3372993
Administered SC
Also known as: LY3372993
Administered IV or SC
Percentage of Participants Who Reach Amyloid Plaque Clearance on Amyloid PET Scan for Remternetug versus Placebo
Time frame: Week 52
Mean Absolute Change from Baseline in Brain Amyloid Plaque on Amyloid PET Scan for Remternetug versus Placebo
Time frame: Baseline, Week 52
Percentage of Participants Who Reach Amyloid Plaque Clearance on Amyloid PET Scan for Remternetug versus Placebo
Time frame: Week 24
Mean Absolute Change from Baseline in Brain Amyloid Plaque on Amyloid PET Scan for Remternetug versus Placebo
Time frame: Baseline, Week 24
Time to Reach Complete Amyloid Plaque Clearance on Remternetug versus Placebo
Time frame: Up to Week 52
Pharmacokinetics (PK) Observed Trough Serum Concentration (Cmin) of Remternetug
Time frame: Baseline to Week 52
Number of Participants with Treatment Emergent Anti-Drug Antibodies (TE-ADAs)
Time frame: Baseline to Week 52
Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting information: Study protocol, Sap, Csr
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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