CompletedPhase 3

A Study of Remternetug (LY3372993) in Participants With Alzheimer's Disease (TRAILRUNNER-ALZ 1)

Assessment of Safety, Tolerability, and Efficacy Measured by Amyloid Reduction of LY3372993 in Early Symptomatic Alzheimer's Disease

Lead sponsor

Eli Lilly and Company

Asset

Remternetug

Listed sites

Recruiting sites

Enrollment

1,667

actual

Study population

Alzheimer’s disease

Key I/E criteria

•MMSE 20-30•Study partner/caregiver required•MRI contraindications excluded

Primary endpoint

•Percentage of Participants Who Reach Amyloid Plaque Clearance on Amyloid PET

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

Org study ID18467

Secondary IDJ1G-MC-LAKCEli Lilly and Company

NCT IDNCT05463731

Timeline

Milestones

Study first posted2022-07-19actual

Study start2022-08-01actual

Primary completion2024-04-24actual

Study completion2026-05-12actual

Last update posted2026-05-22actual

Assets

Drug assets

Remternetug

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age60 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Gradual and progressive change in cognitive function ≥6 months prior to screening.

•A Mini-Mental (MMSE) score of 20 to 30 (inclusive) at screening.

•Has an amyloid PET scan result consistent with the eligibility criteria.

•Have a reliable study partner who will provide written informed consent to participate and is in frequent contact with the participant.

•Have adequate literacy, vision, and hearing for the neuropsychological testing in the opinion of the investigator at the time of screening.

•Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.

•Males and females will be eligible for this study.

•Women not of childbearing potential (WNOCBP) may participate in this trial

Exclusion criteria

•Current serious or unstable illnesses that, in the investigator's opinion, could interfere with the analyses in this study; or has a life expectancy of <24 months.

•History of cancer with high risk of recurrence and preventing completion of the trial.

•Participants with any current primary psychiatric diagnosis other than AD that in the investigator's opinion, is likely to confound interpretation of the drug effect, affect cognitive assessment, or affect the participant's ability to complete the study.

•History of clinically significant multiple or severe drug allergies.

•Have any clinically important abnormality at screening, as determined by investigator that could be detrimental to the participant, could compromise the study, or show evidence of other etiologies for dementia.

•Screening magnetic resonance imaging (MRI) which shows evidence of significant abnormality that would suggest another potential etiology for progressive dementia or a clinically significant finding that may impact the participant's ability to safely participate in the study.

•Have any contraindications for MRI or positron emission tomography (PET).

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

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

•Have known allergies to remternetug related compounds, or any components of the formulation.

Endpoints (7)

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

Amyloid biomarkers

Safety / tolerability / PK

Other (unclassified)

Amyloid biomarkers

5 endpoints

Primary/protocol endpoint

Percentage of Participants Who Reach Amyloid Plaque Clearance on Amyloid PET Scan for Remternetug versus Placebo

Time frame:Week 52

threshold achievement, improvement

Secondary/protocol endpoint

Mean Absolute Change from Baseline in Brain Amyloid Plaque on Amyloid PET Scan for Remternetug versus Placebo

Time frame:Baseline, Week 52

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Who Reach Amyloid Plaque Clearance on Amyloid PET Scan for Remternetug versus Placebo

Time frame:Week 24

threshold achievement, improvement

Secondary/protocol endpoint

Mean Absolute Change from Baseline in Brain Amyloid Plaque on Amyloid PET Scan for Remternetug versus Placebo

Time frame:Baseline, Week 24

change from baseline, improvement

Secondary/protocol endpoint

Time to Reach Complete Amyloid Plaque Clearance on Remternetug versus Placebo

Time frame:Up to Week 52

time to event, event

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Pharmacokinetics (PK) Observed Trough Serum Concentration (Cmin) of Remternetug

Time frame:Baseline to Week 52

concentration, descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

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

Time frame:Baseline to Week 52

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.