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

NCT05463731
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Phase
Phase 3
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Recruitment status
Completed
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Participants
1,667
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Lead sponsor
Eli Lilly and Company
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Start date
2022-08-01
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Number of sites
76
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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).
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Short title
A Study of Remternetug (LY3372993) in Participants With Alzheimer's Disease (TRAILRUNNER-ALZ 1)
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Official title
Assessment of Safety, Tolerability, and Efficacy Measured by Amyloid Reduction of LY3372993 in Early Symptomatic Alzheimer's Disease
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 3
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Study type
Interventional
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Completion date
2026-05-12
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First posted
2022-07-19
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Registry last updated
2026-05-22
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Primary completion date
2024-04-24
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Start date
2022-08-01
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Actual participants
1,667
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Participants
1,667
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Participant count basis
Actual
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Protocol amendments
3
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Number of sites
76
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Eli Lilly and Company
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05463731
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ClinicalTrials.gov ID
NCT05463731
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Registry record
Open registry record
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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
clinicaltrials.gov

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

    Timeframe: Week 52

  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
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
60 Years
Maximum age
85 Years
Healthy volunteers
No

  • 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.

  • 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
clinicaltrials.gov

  • 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
clinicaltrials.gov

Other registry identifiers

  • J1G-MC-LAKC
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (2)