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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05463731
Recruitment Status : Recruiting
First Posted : July 19, 2022
Last Update Posted : May 17, 2023
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
The reason for this study is to collect safety and efficacy information regarding the study drug remternetug in participants with early Alzheimer's disease (AD).

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Remternetug (IV) Drug: Remternetug (SC) Drug: Placebo Phase 3

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 enrollin 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 52 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 640 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: The main treatment period is double-blinded and the addendum is open-label.
Primary Purpose: Treatment
Official Title: Assessment of Safety, Tolerability, and Efficacy Measured by Amyloid Reduction of LY3372993 in Early Symptomatic Alzheimer's Disease
Actual Study Start Date : August 1, 2022
Estimated Primary Completion Date : October 2025
Estimated Study Completion Date : October 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.

 Drug: Remternetug (IV)
Administered IV
Other Name: LY3372993
Experimental: 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.

 Drug: Remternetug (SC)
Administered SC
Other Name: LY3372993
Placebo Comparator: 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.

 Drug: Placebo
Administered IV or SC
Experimental: Open-Label Addenda Remternetug (IV)
Participants will receive one of three dosing regimens of remternetug IV during the open-label addenda.
 Drug: Remternetug (IV)
Administered IV
Other Name: LY3372993
Experimental: Open-Label Addenda Remternetug (SC)
Participants will receive one of two dosing regimens of remternetug SC during the open-label addenda.
 Drug: Remternetug (SC)
Administered SC
Other Name: LY3372993


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants Who Reach Amyloid Plaque Clearance on Amyloid PET Scan for Remternetug versus Placebo [ Time Frame: Week 52 ]

Secondary Outcome Measures :
  1. Mean Absolute Change from Baseline in Brain Amyloid Plaque on Amyloid PET Scan for Remternetug versus Placebo [ Time Frame: Baseline, Week 52 ]
  2. Percentage of Participants Who Reach Amyloid Plaque Clearance on Amyloid PET Scan for Remternetug versus Placebo [ Time Frame: Week 24 ]
  3. Mean Absolute Change from Baseline in Brain Amyloid Plaque on Amyloid PET Scan for Remternetug versus Placebo [ Time Frame: Baseline, Week 24 ]
  4. Time to Reach Complete Amyloid Plaque Clearance on Remternetug versus Placebo [ Time Frame: Up to Week 52 ]
  5. Pharmacokinetics (PK) Observed Trough Serum Concentration (Cmin) of Remternetug [ Time Frame: Baseline to Week 52 ]
  6. Number of Participants with Treatment Emergent Anti-Drug Antibodies (TE-ADAs) [ Time Frame: Baseline to Week 52 ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Gradual and progressive change in cognitive function ≥6 months prior to screening.
  • A Mini-Mental (MMSE) score of 20 to 28 (inclusive) at screening.
  • Has a P-tau result consistent with the presence of amyloid pathology.
  • Has an amyloid PET scan result consistent with the presence of brain amyloid pathology.
  • 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:

  • Significant neurological disease affecting the central nervous system (CNS) other than AD, that may affect cognition or ability to complete the study.
  • 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 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 that is <5 half-lives prior to randomization.
  • Have received active immunization against Aβ in any other study.
  • Have known allergies to remternetug related compounds, or any components of the formulation.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05463731


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 ClinicalTrials.gov@lilly.com

Locations
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Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: 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
More Information
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Additional Information:

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT05463731    
Other Study ID Numbers: 18467
J1G-MC-LAKC ( Other Identifier: Eli Lilly and Company )
First Posted: July 19, 2022    Key Record Dates
Last Update Posted: May 17, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (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.
URL: http://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eli Lilly and Company:
Mild cognitive impairment
Alzheimer's disease
Dementia
 Amyloid-beta therapy
Amyloid Plaque
Disease modifying
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders