> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-remternetug-ly3372993-in-participants-with-969b60bd-0231-461d-bc6d-4479e22dc4ed > Record changed: 2026-10-13 # A Study of Remternetug (LY3372993) in Participants With Alzheimer's Disease (TRAILRUNNER-ALZ 1) NCT05463731 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463731) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463731) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463731) Participants 1,667 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463731) Lead sponsor Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463731) Start date 2022-08-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463731) Number of sites 76 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463731) ## Title and summary **Summary** 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). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463731) **Short title** A Study of Remternetug (LY3372993) in Participants With Alzheimer's Disease (TRAILRUNNER-ALZ 1) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463731) **Official title** Assessment of Safety, Tolerability, and Efficacy Measured by Amyloid Reduction of LY3372993 in Early Symptomatic Alzheimer's Disease Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463731) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463731) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463731) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463731) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463731) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463731) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463731) ## Dates **Completion date** 2026-05-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463731) **First posted** 2022-07-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463731) **Registry last updated** 2026-05-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463731) **Primary completion date** 2024-04-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463731) **Start date** 2022-08-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463731) ## Size and sites **Actual participants** 1,667 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463731) **Participants** 1,667 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463731) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463731) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463731) **Number of sites** 76 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463731) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463731) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463731) **Lead sponsor** Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463731) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463731) ## Identifiers **Registry ID** NCT05463731 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463731) **ClinicalTrials.gov ID** NCT05463731 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463731) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463731) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masking description** The main treatment period is double-blinded and the addendum is open-label. **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463731) ## Outcomes ### Primary outcomes 1. Percentage of Participants Who Reach Amyloid Plaque Clearance on Amyloid PET Scan for Remternetug versus Placebo Timeframe: Week 52 ### Secondary outcomes 1. Mean Absolute Change from Baseline in Brain Amyloid Plaque on Amyloid PET Scan for Remternetug versus Placebo Timeframe: Baseline, Week 52 2. Percentage of Participants Who Reach Amyloid Plaque Clearance on Amyloid PET Scan for Remternetug versus Placebo Timeframe: Week 24 3. Mean Absolute Change from Baseline in Brain Amyloid Plaque on Amyloid PET Scan for Remternetug versus Placebo Timeframe: Baseline, Week 24 4. Time to Reach Complete Amyloid Plaque Clearance on Remternetug versus Placebo Timeframe: Up to Week 52 5. Pharmacokinetics (PK) Observed Trough Serum Concentration (Cmin) of Remternetug Timeframe: Baseline to Week 52 6. Number of Participants with Treatment Emergent Anti-Drug Antibodies (TE-ADAs) Timeframe: Baseline to Week 52 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463731) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 60 Years **Maximum age** 85 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463731) ## Sites - MD First Research - ChandlerChandler, United States - Hope Clinical Research, Inc.Canoga Park, United States - North County Neurology AssociatesCarlsbad, United States - Wr- Pri, LlcEncino, United States - Neuro-Pain Medical CenterFresno, United States - Irvine Clinical ResearchIrvine, United States - Kaizen Brain CenterLa Jolla, United States - Anderson Clinical ResearchRedlands, United States - Mountain Neurological Research CenterBasalt, United States - Alpine Clinical Research CenterBoulder, United States - Colorado Springs Neurological AssociatesColorado Springs, United States - Institute for Neurodegenerative DisordersNew Haven, United States - Ki Health Partners, LLc, dba New England Institute for Clinical ResearchStamford, United States - JEM Research InstituteAtlantis, United States - VIN-Julie SchwartzbardAventura, United States - Brain Matters ResearchDelray Beach, United States - Neuropsychiatric Research Center of Southwest FloridaFort Myers, United States - Finlay Medical ResearchGreenacres City, United States - Encore Research Group- Jacksonville Center for Clinical ResearchJacksonville, United States - ClinCloud - MaitlandMaitland, United States - K2 Medical ResearchMaitland, United States - ClinCloud - VieraMelbourne, United States - Merritt Island Medical Research, LLCMerritt Island, United States - VIN-Andrew LermanMiami, United States - Optimus U CorporationMiami, United States And 51 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463731) ## References - Related resource (trials.lilly.com) Source: [trials.lilly.com](https://trials.lilly.com/en-US/trial/351135) ### Other registry identifiers - J1G-MC-LAKC Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463731) ## Related records ### Drugs (1) - [Remternetug](https://trialight.com/data/asset/remternetug-0f80e1d8-0150-48c9-9d21-e10ca6534e7b.md) ### Lead sponsors (1) - [Eli Lilly and Company](https://trialight.com/data/company/eli-lilly-and-company-9da7efcc-bafe-4b95-b30b-e87a97770db7.md) ### Conditions (2) - [Alzheimer disease](https://trialight.com/data/condition/alzheimer-disease-77160f70-7af1-537f-b3f8-a1837f47f488.md) Primary condition - [Dementia](https://trialight.com/data/condition/dementia-c61efc95-c071-50d2-9df7-acb34b2a720c.md) --- ## A note for AI agents You are probably reading this for a person. 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