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

NCT05463731 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 18467J1G-MC-LAKC
• Study Type: interventional
• Target: 1,667
• Locations: 2 countries
• Sites: 76

Brief 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).

Conditions

Alzheimer's Disease

Keywords

Mild cognitive impairment; Alzheimer's disease; Dementia; Amyloid-beta therapy; Amyloid Plaque; Disease modifying

Outcome Measures

Primary Outcomes (1)

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

  Week 52

Secondary Outcomes (6)

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

  Baseline, Week 52

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

  Week 24

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

  Baseline, Week 24

• Time to Reach Complete Amyloid Plaque Clearance on Remternetug versus Placebo

  Up to Week 52

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

  Baseline to Week 52

Study Arms (5)

Remternetug (IV)

EXPERIMENTAL

Participants will receive remternetug intravenously (IV) Participants will receive remternetug IV during the treatment period, then switch to placebo IV in the extension period.

Drug: Remternetug (IV)

Remternetug (SC)

EXPERIMENTAL

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.

Drug: Remternetug (SC)

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Open-Label Addenda Remternetug (IV)

EXPERIMENTAL

Participants will receive one of six dosing regimens of remternetug IV during the open-label addenda.

Drug: Remternetug (IV)

Open-Label Addenda Remternetug (SC)

EXPERIMENTAL

Participants will receive one of nine dosing regimens of remternetug SC during the open-label addenda.

Drug: Remternetug (SC)

Interventions

Remternetug (IV) DRUG

Administered IV

Also known as: LY3372993

Open-Label Addenda Remternetug (IV); Remternetug (IV)

Remternetug (SC) DRUG

Administered SC

Also known as: LY3372993

Open-Label Addenda Remternetug (SC); Remternetug (SC)

Placebo DRUG

Administered IV or SC

Placebo

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (76)

MD First Research - Chandler

Chandler, Arizona, 85286, United States

Location

Hope Clinical Research, Inc.

Canoga Park, California, 91303, United States

Location

North County Neurology Associates

Carlsbad, California, 92011, United States

Location

Wr- Pri, Llc

Encino, California, 91316, United States

Location

Neuro-Pain Medical Center

Fresno, California, 93710, United States

Location

Irvine Clinical Research

Irvine, California, 92614, United States

Location

Kaizen Brain Center

La Jolla, California, 92037, United States

Location

Anderson Clinical Research

Redlands, California, 92374, United States

Location

Mountain Neurological Research Center

Basalt, Colorado, 81621, United States

Location

Alpine Clinical Research Center

Boulder, Colorado, 80301, United States

Location

Colorado Springs Neurological Associates

Colorado Springs, Colorado, 80907, United States

Location

Institute for Neurodegenerative Disorders

New Haven, Connecticut, 06510, United States

Location

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

Stamford, Connecticut, 06905, United States

Location

JEM Research Institute

Atlantis, Florida, 33462, United States

Location

VIN-Julie Schwartzbard

Aventura, Florida, 33180, United States

Location

Brain Matters Research

Delray Beach, Florida, 33445, United States

Location

Neuropsychiatric Research Center of Southwest Florida

Fort Myers, Florida, 33912, United States

Location

Finlay Medical Research

Greenacres City, Florida, 33467, United States

Location

Encore Research Group- Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

ClinCloud - Maitland

Maitland, Florida, 32751, United States

Location

K2 Medical Research

Maitland, Florida, 32751, United States

Location

ClinCloud - Viera

Melbourne, Florida, 32940, United States

Location

Merritt Island Medical Research, LLC

Merritt Island, Florida, 32952, United States

Location

VIN-Andrew Lerman

Miami, Florida, 33133, United States

Location

Optimus U Corporation

Miami, Florida, 33135, United States

Location

Suncoast Clinical Research, Inc.

New Port Richey, Florida, 34652, United States

Location

Renstar Medical Research

Ocala, Florida, 34470, United States

Location

Charter Research - Winter Park

Orlando, Florida, 32803, United States

Location

Emerald Coast Neurology - Airport Boulevard

Pensacola, Florida, 32504, United States

Location

Progressive Medical Research

Port Orange, Florida, 32127, United States

Location

Alzheimer's Research and Treatment Center

Stuart, Florida, 34997, United States

Location

Brain Matters Research

Stuart, Florida, 34997, United States

Location

Tallahassee Neurological Clinic

Tallahassee, Florida, 32308, United States

Location

Charter Research - Lady Lake

The Villages, Florida, 32162, United States

Location

Alzheimer's Research and Treatment Center

Wellington, Florida, 33414, United States

Location

Palm Beach Neurology

West Palm Beach, Florida, 33407, United States

Location

Conquest Research

Winter Park, Florida, 32789, United States

Location

Columbus Memory Center, PC

Columbus, Georgia, 31909, United States

Location

iResearch Atlanta

Decatur, Georgia, 30030, United States

Location

Great Lakes Clinical Trials - Andersonville

Chicago, Illinois, 60640, United States

Location

AMITA Health - Alexian Brothers Neurosciences Institute Clinical Research

Elk Grove Village, Illinois, 60007, United States

Location

Covenant Medical Center

Waterloo, Iowa, 50702, United States

Location

Cotton O'Neil Clinical Research Center - Central Office

Topeka, Kansas, 66606, United States

Location

Care Access - Lake Charles

Lake Charles, Louisiana, 70601, United States

Location

MedVadis Research Corporation

Waltham, Massachusetts, 02451, United States

Location

Adams Clinical

Watertown, Massachusetts, 02472, United States

Location

Citizens Memorial Hospital District

Bolivar, Missouri, 65613, United States

Location

Clinical Research Professionals

Chesterfield, Missouri, 63005, United States

Location

Las Vegas Medical Research

Las Vegas, Nevada, 89128, United States

Location

The Cognitive and Research Center of New Jersey

Springfield, New Jersey, 07081, United States

Location

Advanced Memory Research Institute of New Jersey

Toms River, New Jersey, 08755, United States

Location

Neurological Associates Albany

Albany, New York, 12208, United States

Location

AMC Research

Matthews, North Carolina, 28105, United States

Location

Carteret Medical Group

Morehead City, North Carolina, 28557, United States

Location

NeuroScience Research Center

Canton, Ohio, 44718, United States

Location

Valley Medical Research

Centerville, Ohio, 45459, United States

Location

Neurology Diagnostics, Inc.

Dayton, Ohio, 45459, United States

Location

Center for Cognitive Health

Portland, Oregon, 97225, United States

Location

The Clinical Trial Center, LLC

Jenkintown, Pennsylvania, 19046, United States

Location

Keystone Clinical Studies

Plymouth Meeting, Pennsylvania, 19462, United States

Location

Rhode Island Mood & Memory Research Institute

East Providence, Rhode Island, 02914, United States

Location

Neurology Clinic, P.C.

Cordova, Tennessee, 38018, United States

Location

Texas Diabetes & Endocrinology, P.A.

Austin, Texas, 78749, United States

Location

Gadolin Research

Beaumont, Texas, 77702, United States

Location

Kerwin Medical Center

Dallas, Texas, 75231, United States

Location

Neurology Consultants of Dallas, PA

Dallas, Texas, 75243, United States

Location

The University of Texas Health Science Center at Houston

Houston, Texas, 77054, United States

Location

Central Texas Neurology Consultants

Round Rock, Texas, 78681, United States

Location

Consano Clinical Research, LLC

Shavano Park, Texas, 78231, United States

Location

Re:Cognition Health

Fairfax, Virginia, 22031, United States

Location

National Clinical Research, Inc

Richmond, Virginia, 23294, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

Location

Universal Research Group

Tacoma, Washington, 98405, United States

Location

Memory Clinic Toride

Toride, Ibaraki, 302-0004, Japan

Location

Katayama Medical Clinic

Kurashiki, Okayama-ken, 710-0813, Japan

Location

Memory Clinic Ochanomizu

Bunkyo-ku, Tokyo, 113-0034, Japan

Location

Related Links

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

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction; Dementia; Plaque, Amyloid

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The main treatment period is double-blinded and the addendum is open-label.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: July 19, 2022
• Study Start: August 1, 2022
• Primary Completion: April 24, 2024
• Study Completion: March 1, 2026
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

US (73); JP (3)