Active not recruitingPhase 3

A Study of Remternetug (LY3372993) in Early Alzheimer's Disease (TRAILRUNNER-ALZ 3)

A Study of Remternetug Versus Placebo in Early Alzheimer's Disease Participants at Risk for Cognitive and Functional Decline

Lead sponsor

Eli Lilly and Company

Asset

Remternetug

Listed sites

262

Recruiting sites

Enrollment

1,400

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•Amyloid biomarker required•Tau biomarker required•Study partner/caregiver required•MRI contraindications excluded

Primary endpoint

•Clinically Meaningful Progression

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Ctis2024-515656-20-00

Org study ID27183

Secondary IDJ1G-MC-LAKIEli Lilly and Company

NCT IDNCT06653153

Timeline

Milestones

Study first posted2024-10-22actual

Study start2024-10-24actual

Last update posted2025-11-20actual

Primary completion2029-04estimated (month precision)

Study completion2030-10estimated (month precision)

Assets

Drug assets

Remternetug

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

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, vision, and hearing for neuropsychological testing at screening.

•Have a Mini Mental Status Exam (MMSE) score consistent with no to minimal cognitive impairment.

•Have a Functional Activities Questionnaire (FAQ) score consistent with no to minimal functional impairment.

•If currently receiving medications as symptomatic treatment for AD, dose has been stable for at least 30 days before screening

Exclusion criteria

•Have dementia or significant other neurological disease that can affect cognition.

•Have current serious or unstable illnesses that in the investigator's opinion, could interfere with the analyses of the study.

•Have a history of cancer that, in the investigator's opinion, has a high risk of recurrence.

•Have a history of clinically significant multiple or severe drug allergies, or hypersensitivity reactions.

•Have a clinically important laboratory test result or other abnormality as determined by investigator, prior to randomization, that could be detrimental to the participant or could compromise the study.

•Have any contraindications for magnetic resonance imaging (MRI).

•Have a centrally read MRI that does not meets study entry criteria.

Prior or Current Therapies

•Have ever had prior treatment with a passive anti-amyloid immunotherapy.

•Have received active immunization against Aβ in any other study.

Endpoints (12)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Memory

Other (unclassified)

Global cognition

Function / daily living

Safety / tolerability / PK

Global cognition

2 endpoints

Secondary/protocol endpoint

Change from Baseline in Montreal Cognitive Assessment (MoCA)

Time frame:Baseline, Week 255

Montreal Cognitive Assessment (MoCA)

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Cognitive Function Index (CFI)

Time frame:Baseline, Week 255

change from baseline, improvement

Memory

4 endpoints

Secondary/protocol endpoint

Change from Baseline in the Category Fluency - Language, Executive Function, Semantic Memory

Time frame:Baseline, Week 255

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in the Continuous Paired Associate Learning (CPAL)

Time frame:Baseline, Week 255

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in International Shopping List Test (ISLT) - Verbal Episodic Mem

Time frame:Baseline, Week 255

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in International Daily Symbol Substitution Test-Medicines (iDSSTm) - Complex Attention Memory

Time frame:Baseline, Week 255

change from baseline, improvement

Function / daily living

1 endpoint

Secondary/protocol endpoint

Change from Baseline in Alzheimer's Disease Cooperative Study (ADCS) Activities of Daily Living - Prevention Instrument (ADCS-ADL-PI)

Time frame:Baseline, Week 255

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Pharmacokinetics: Serum Concentrations of Remternetug

Time frame:Baseline through Week 255

concentration, descriptive

Other (unclassified)

4 endpoints

Primary/protocol endpoint/low confidence

Time to Clinically Meaningful Progression as Measured by Clinical Dementia Rate Scale (CDR)

Time frame:Baseline to Time to Event up to Week 255

time to event, event

Secondary/protocol endpoint/low confidence

Change from Baseline in Clinical Dementia Rate Box Score (SB)

Time frame:Baseline, Week 255

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from Baseline in Mild Behavioral Impairment Checklist (MBI-C)

Time frame:Baseline, Week 255

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Number of Participants with Treatment Emergent Anti-Drug Antibodies (TE-ADAs)

Time frame:Baseline through Week 255

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.