A Study of Remternetug (LY3372993) in Participants With Alzheimer's Disease (TRAILRUNNER-ALZ 1)
NCT ID: NCT05463731
Last Updated: 2025-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
1667 participants
INTERVENTIONAL
2022-08-01
2026-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Remternetug (IV)
Participants will receive remternetug intravenously (IV)
Participants will receive remternetug IV during the treatment period, then switch to placebo IV in the extension period.
Remternetug (IV)
Administered IV
Remternetug (SC)
Participants 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.
Remternetug (SC)
Administered SC
Placebo
Participants 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.
Placebo
Administered IV or SC
Open-Label Addenda Remternetug (IV)
Participants will receive one of six dosing regimens of remternetug IV during the open-label addenda.
Remternetug (IV)
Administered IV
Open-Label Addenda Remternetug (SC)
Participants will receive one of nine dosing regimens of remternetug SC during the open-label addenda.
Remternetug (SC)
Administered SC
Interventions
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Remternetug (IV)
Administered IV
Remternetug (SC)
Administered SC
Placebo
Administered IV or SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
60 Years
85 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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MD First Research - Chandler
Chandler, Arizona, United States
Hope Clinical Research, Inc.
Canoga Park, California, United States
North County Neurology Associates
Carlsbad, California, United States
Wr- Pri, Llc
Encino, California, United States
Neuro-Pain Medical Center
Fresno, California, United States
Irvine Clinical Research
Irvine, California, United States
Kaizen Brain Center
La Jolla, California, United States
Anderson Clinical Research
Redlands, California, United States
Mountain Neurological Research Center
Basalt, Colorado, United States
Alpine Clinical Research Center
Boulder, Colorado, United States
Colorado Springs Neurological Associates
Colorado Springs, Colorado, United States
Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States
Ki Health Partners, LLc, dba New England Institute for Clinical Research
Stamford, Connecticut, United States
JEM Research Institute
Atlantis, Florida, United States
VIN-Julie Schwartzbard
Aventura, Florida, United States
Brain Matters Research
Delray Beach, Florida, United States
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, United States
Finlay Medical Research
Greenacres City, Florida, United States
Encore Research Group- Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
ClinCloud - Maitland
Maitland, Florida, United States
K2 Medical Research
Maitland, Florida, United States
ClinCloud - Viera
Melbourne, Florida, United States
Merritt Island Medical Research, LLC
Merritt Island, Florida, United States
VIN-Andrew Lerman
Miami, Florida, United States
Optimus U Corporation
Miami, Florida, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Charter Research - Winter Park
Orlando, Florida, United States
Emerald Coast Neurology - Airport Boulevard
Pensacola, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Alzheimer's Research and Treatment Center
Stuart, Florida, United States
Brain Matters Research
Stuart, Florida, United States
Tallahassee Neurological Clinic
Tallahassee, Florida, United States
Charter Research - Lady Lake
The Villages, Florida, United States
Alzheimer's Research and Treatment Center
Wellington, Florida, United States
Palm Beach Neurology
West Palm Beach, Florida, United States
Conquest Research
Winter Park, Florida, United States
Columbus Memory Center, PC
Columbus, Georgia, United States
iResearch Atlanta
Decatur, Georgia, United States
Great Lakes Clinical Trials - Andersonville
Chicago, Illinois, United States
AMITA Health - Alexian Brothers Neurosciences Institute Clinical Research
Elk Grove Village, Illinois, United States
Covenant Medical Center
Waterloo, Iowa, United States
Cotton O'Neil Clinical Research Center - Central Office
Topeka, Kansas, United States
Care Access - Lake Charles
Lake Charles, Louisiana, United States
MedVadis Research Corporation
Waltham, Massachusetts, United States
Adams Clinical
Watertown, Massachusetts, United States
Citizens Memorial Hospital District
Bolivar, Missouri, United States
Clinical Research Professionals
Chesterfield, Missouri, United States
Las Vegas Medical Research
Las Vegas, Nevada, United States
The Cognitive and Research Center of New Jersey
Springfield, New Jersey, United States
Advanced Memory Research Institute of New Jersey
Toms River, New Jersey, United States
Neurological Associates Albany
Albany, New York, United States
AMC Research
Matthews, North Carolina, United States
Carteret Medical Group
Morehead City, North Carolina, United States
NeuroScience Research Center
Canton, Ohio, United States
Valley Medical Research
Centerville, Ohio, United States
Neurology Diagnostics, Inc.
Dayton, Ohio, United States
Center for Cognitive Health
Portland, Oregon, United States
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, United States
Keystone Clinical Studies
Plymouth Meeting, Pennsylvania, United States
Rhode Island Mood & Memory Research Institute
East Providence, Rhode Island, United States
Neurology Clinic, P.C.
Cordova, Tennessee, United States
Texas Diabetes & Endocrinology, P.A.
Austin, Texas, United States
Gadolin Research
Beaumont, Texas, United States
Kerwin Medical Center
Dallas, Texas, United States
Neurology Consultants of Dallas, PA
Dallas, Texas, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Central Texas Neurology Consultants
Round Rock, Texas, United States
Consano Clinical Research, LLC
Shavano Park, Texas, United States
Re:Cognition Health
Fairfax, Virginia, United States
National Clinical Research, Inc
Richmond, Virginia, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Universal Research Group
Tacoma, Washington, United States
Memory Clinic Toride
Toride, Ibaraki, Japan
Katayama Medical Clinic
Kurashiki, Okayama-ken, Japan
Memory Clinic Ochanomizu
Bunkyo-ku, Tokyo, Japan
Countries
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Related Links
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A Study of Remternetug (LY3372993) in Participants With Alzheimer's Disease (TRAILRUNNER-ALZ 1)
Other Identifiers
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J1G-MC-LAKC
Identifier Type: OTHER
Identifier Source: secondary_id
18467
Identifier Type: -
Identifier Source: org_study_id
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