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Alzheimer's DiseasePhase 3NCT05463731

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

A Phase 3 study testing Remternetug (IV) and Remternetug (SC) in people with Alzheimer's Disease, run by Eli Lilly and Company at 76 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 60 to 85 years
Conditions the study is for
Alzheimer's Disease
What is being tested?
Remternetug (IV) and Remternetug (SC)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,667 participants
Where
76 sitesin 2 countries
Study dates
1 Aug 2022to 12 May 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

76 sites in 2 countries.

76 sites in 2 countries

United States73 sites

  • Neurological Associates Albany

    Albany, New York, 12208

  • JEM Research Institute

    Atlantis, Florida, 33462

  • Texas Diabetes & Endocrinology, P.A.

    Austin, Texas, 78749

  • VIN-Julie Schwartzbard

    Aventura, Florida, 33180

  • Mountain Neurological Research Center

    Basalt, Colorado, 81621

  • Gadolin Research

    Beaumont, Texas, 77702

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

  • Citizens Memorial Hospital District

    Bolivar, Missouri, 65613

  • Alpine Clinical Research Center

    Boulder, Colorado, 80301

  • Hope Clinical Research, Inc.

    Canoga Park, California, 91303

  • NeuroScience Research Center

    Canton, Ohio, 44718

  • North County Neurology Associates

    Carlsbad, California, 92011

  • Valley Medical Research

    Centerville, Ohio, 45459

  • MD First Research - Chandler

    Chandler, Arizona, 85286

  • Clinical Research Professionals

    Chesterfield, Missouri, 63005

  • Great Lakes Clinical Trials - Andersonville

    Chicago, Illinois, 60640

  • Colorado Springs Neurological Associates

    Colorado Springs, Colorado, 80907

  • Columbus Memory Center, PC

    Columbus, Georgia, 31909

  • Neurology Clinic, P.C.

    Cordova, Tennessee, 38018

  • Kerwin Medical Center

    Dallas, Texas, 75231

  • Neurology Consultants of Dallas, PA

    Dallas, Texas, 75243

  • Neurology Diagnostics, Inc.

    Dayton, Ohio, 45459

  • iResearch Atlanta

    Decatur, Georgia, 30030

  • Brain Matters Research

    Delray Beach, Florida, 33445

  • Rhode Island Mood & Memory Research Institute

    East Providence, Rhode Island, 02914

  • AMITA Health - Alexian Brothers Neurosciences Institute Clinical Research

    Elk Grove Village, Illinois, 60007

  • Wr- Pri, Llc

    Encino, California, 91316

  • Re:Cognition Health

    Fairfax, Virginia, 22031

  • Neuropsychiatric Research Center of Southwest Florida

    Fort Myers, Florida, 33912

  • Neuro-Pain Medical Center

    Fresno, California, 93710

  • Finlay Medical Research

    Greenacres City, Florida, 33467

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77054

  • Irvine Clinical Research

    Irvine, California, 92614

  • Encore Research Group- Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • The Clinical Trial Center, LLC

    Jenkintown, Pennsylvania, 19046

  • Kaizen Brain Center

    La Jolla, California, 92037

  • Care Access - Lake Charles

    Lake Charles, Louisiana, 70601

  • Las Vegas Medical Research

    Las Vegas, Nevada, 89128

  • ClinCloud - Maitland

    Maitland, Florida, 32751

  • K2 Medical Research

    Maitland, Florida, 32751

  • AMC Research

    Matthews, North Carolina, 28105

  • ClinCloud - Viera

    Melbourne, Florida, 32940

  • Merritt Island Medical Research, LLC

    Merritt Island, Florida, 32952

  • VIN-Andrew Lerman

    Miami, Florida, 33133

  • Optimus U Corporation

    Miami, Florida, 33135

  • Carteret Medical Group

    Morehead City, North Carolina, 28557

  • Institute for Neurodegenerative Disorders

    New Haven, Connecticut, 06510

  • Suncoast Clinical Research, Inc.

    New Port Richey, Florida, 34652

  • Renstar Medical Research

    Ocala, Florida, 34470

  • Charter Research - Winter Park

    Orlando, Florida, 32803

  • Emerald Coast Neurology - Airport Boulevard

    Pensacola, Florida, 32504

  • Keystone Clinical Studies

    Plymouth Meeting, Pennsylvania, 19462

  • Progressive Medical Research

    Port Orange, Florida, 32127

  • Center for Cognitive Health

    Portland, Oregon, 97225

  • Anderson Clinical Research

    Redlands, California, 92374

  • National Clinical Research, Inc

    Richmond, Virginia, 23294

  • Central Texas Neurology Consultants

    Round Rock, Texas, 78681

  • Consano Clinical Research, LLC

    Shavano Park, Texas, 78231

  • The Cognitive and Research Center of New Jersey

    Springfield, New Jersey, 07081

  • Ki Health Partners, LLc, dba New England Institute for Clinical Research

    Stamford, Connecticut, 06905

  • Alzheimer's Research and Treatment Center

    Stuart, Florida, 34997

  • Brain Matters Research

    Stuart, Florida, 34997

  • Universal Research Group

    Tacoma, Washington, 98405

  • Tallahassee Neurological Clinic

    Tallahassee, Florida, 32308

  • Charter Research - Lady Lake

    The Villages, Florida, 32162

  • Advanced Memory Research Institute of New Jersey

    Toms River, New Jersey, 08755

  • Cotton O'Neil Clinical Research Center - Central Office

    Topeka, Kansas, 66606

  • MedVadis Research Corporation

    Waltham, Massachusetts, 02451

  • Covenant Medical Center

    Waterloo, Iowa, 50702

  • Adams Clinical

    Watertown, Massachusetts, 02472

  • Alzheimer's Research and Treatment Center

    Wellington, Florida, 33414

  • Palm Beach Neurology

    West Palm Beach, Florida, 33407

  • Conquest Research

    Winter Park, Florida, 32789

Other trials in United States

Japan3 sites

  • Memory Clinic Ochanomizu

    Bunkyo-ku, Tokyo, 113-0034

  • Katayama Medical Clinic

    Kurashiki, Okayama-ken, 710-0813

  • Memory Clinic Toride

    Toride, Ibaraki, 302-0004

Other trials in Japan

About this study

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

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).

Read the detailed description

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.

Being tested
Remternetug (IV), Remternetug (SC), Placebo
Keywords
Mild cognitive impairment, Alzheimer's disease, Dementia, Amyloid-beta therapy, Amyloid Plaque, Disease modifying
Medical subject headings
Alzheimer Disease, Cognitive Dysfunction, Dementia, Plaque, Amyloid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Remternetug (IV)Drug

    Also called LY3372993

    Administered IV

  • Remternetug (SC)Drug

    Also called LY3372993

    Administered SC

  • PlaceboDrug

    Administered IV or SC

Study groups in NCT05463731
Study groupRoleWhat they receive
Remternetug (IV)ExperimentalParticipants will receive remternetug intravenously (IV) Participants will receive remternetug IV during the treatment period, then switch to placebo IV in the extension period.
Receives: Drug: Remternetug (IV)
Remternetug (SC)ExperimentalParticipants 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.
Receives: Drug: Remternetug (SC)
PlaceboPlacebo comparatorParticipants 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.
Receives: Drug: Placebo
Open-Label Addenda Remternetug (IV)ExperimentalParticipants will receive one of six dosing regimens of remternetug IV during the open-label addenda.
Receives: Drug: Remternetug (IV)
Open-Label Addenda Remternetug (SC)ExperimentalParticipants will receive one of nine dosing regimens of remternetug SC during the open-label addenda.
Receives: Drug: Remternetug (SC)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Week 52

Secondary outcomes (6)

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

    Measured: Baseline, Week 52

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

    Measured: Week 24

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

    Measured: Baseline, Week 24

  4. Time to Reach Complete Amyloid Plaque Clearance on Remternetug versus Placebo

    Measured: Up to Week 52

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

    Measured: Baseline to Week 52

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

    Measured: Baseline to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2022
  2. Study start1 Aug 2022
  3. Primary completion24 Apr 2024
  4. Study completion12 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,667 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05463731
Sponsor's protocol ID
18467
Other IDs
J1G-MC-LAKC
Status last verified
May 2026
First submitted
14 Jul 2022
Last updated
22 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Remternetug (IV) and Remternetug (SC) in people with Alzheimer's Disease, run by Eli Lilly and Company at 76 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in United States, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Who Reach Amyloid Plaque Clearance on Amyloid PET Scan for Remternetug versus Placebo (time frame: Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05463731.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.

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