Remternetug for Healthy Subjects

Not currently recruiting at 2 trial locations

Overseen By There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Eli Lilly and Company

Must not be taking: Herbal medications

Disqualifiers: Cardiovascular, Neuropsychiatric, Early onset AD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods of administering a new treatment called remternetug to healthy volunteers. Researchers aim to determine how much of the drug enters the bloodstream and how quickly the body processes it when delivered via an autoinjector or a prefilled syringe. Participants should be generally healthy without major health issues affecting the heart, lungs, or other organs. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Do I have to stop taking my current medications for the trial?

Yes, you will need to stop taking over-the-counter or prescription medications, including herbal and traditional medications, at least 7 days before the study and during the trial, except for vitamin/mineral supplements, hormone replacement therapy, and thyroid replacement therapy.

What prior data suggests that these formulations of remternetug are safe?

Research has shown that remternetug has been tested in both healthy individuals and those with early Alzheimer's disease. These studies enhance understanding of the drug's mechanism and safety profile.

For those using the autoinjector, trial data indicate that remternetug is generally well-tolerated. Serious side effects are rare in healthy participants. Most side effects, if they occur, are mild and include redness or swelling at the injection site.

When used with a prefilled syringe, the safety results are similar. The main side effects remain mild, such as discomfort at the injection site.

As this trial is in its early phase, it focuses on understanding the drug's mechanism and ensuring its safety for participants. The progression of remternetug to this phase suggests it is considered safe enough for continued testing in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Remternetug is unique because it offers a new delivery method for administering treatments. Unlike standard treatments, which often involve intravenous infusions, Remternetug is designed for subcutaneous administration, either through an autoinjector or a prefilled syringe. This could make the treatment process more convenient and less invasive for patients. Researchers are excited because these methods might improve patient comfort and adherence, potentially enhancing overall treatment outcomes.

What evidence suggests that this trial's treatments could be effective?

Research has shown that remternetug is being studied as a possible treatment for early Alzheimer's disease. It targets amyloid plaques in the brain, believed to contribute to the disease's progression. Reducing these plaques might help slow Alzheimer's. Studies have found that remternetug effectively reduces these plaques, which is promising for improving memory and thinking skills. In this trial, participants will receive remternetug either subcutaneously via autoinjector or via prefilled syringe to evaluate the method of administration. Although this trial focuses on how the drug is given, the treatment itself has shown potential in addressing Alzheimer's disease. ^{5 6 7 8 9}

Who Is on the Research Team?

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)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for healthy individuals who are interested in participating in a study to compare two different ways of administering a drug called Remternetug. Participants will be given the drug either with an autoinjector or a prefilled syringe and must be available for around 155 days.

Inclusion Criteria

Have a body mass index within the range of 18.0 to 34.0 kilograms per meter squared (kg/m2) (inclusive)

I am generally healthy as confirmed by recent medical exams and tests.

Exclusion Criteria

Have a brain MRI that demonstrates any clinically significant findings that, in the opinion of the investigator, may impact the participant's ability to safely participate in the study

Have evidence of significant active neuropsychiatric disease, as determined by the investigator

I plan to use medication other than vitamins, hormone, or thyroid therapy during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single subcutaneous administration of remternetug using either an autoinjector or a prefilled syringe

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pharmacokinetics and safety after administration

approximately 22 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Remternetug

Trial Overview

The study is testing two formulations of Remternetug, delivered via subcutaneous injection using either an autoinjector (AI) or a prefilled syringe (PFS). It aims to measure how much of the drug enters the bloodstream and its elimination rate from the body.

How Is the Trial Designed?

Group I: Remternetug (Test) Experimental Treatment 1 Intervention

Remternetug administered subcutaneously (SC) via autoinjector (AI)

Group II: Remternetug (Reference) Experimental Treatment 1 Intervention

Remternetug administered SC via prefilled syringe.

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05463731

NCT05463731 | A Study of Remternetug (LY3372993) in ...

The reason for this study is to collect safety and efficacy information regarding the study drug remternetug in participants with early symptomatic Alzheimer's ...

2.

neurologylive.com

neurologylive.com/view/phase-3-trailrunner-alz-3-test-effects-igg1-monoclonal-antibody-remternetug-early-alzheimer-disease

Phase 3 TRAILRUNNER-ALZ 3 to Test Effects of IgG1 ...

The phase 3 study will assess remternetug's efficacy in early-stage Alzheimer's, focusing on amyloid plaque reduction and cognitive outcomes.

3.

clinicaltrialsarena.com

clinicaltrialsarena.com/features/trials-to-watch-three-major-catalysts-in-alzheimers-disease/

Trials to watch: Three major catalysts in Alzheimer's disease

The patients will be administered open-label remternetug via subcutaneous injection or intravenous infusion. The study is due to complete in ...

4.

hpgpwirral.nhs.uk

hpgpwirral.nhs.uk/wp-content/uploads/2025/01/J1G-MC-LAKI_Main_ICF_Trial-Level-Consent_V2.0_dated-04NOV2024_Final_Clean.pdf

A Study of Remternetug Versus Placebo in Early ...

A Study of Remternetug Versus Placebo in Early Alzheimer's. Disease Participants at Risk for Cognitive and Functional Decline.

5.

trial.medpath.com

trial.medpath.com/news/598e8c39e65e9f99/phase-3-trailrunner-alz-3-to-test-effects-of-igg1-monoclonal-antibody-remternetug-in

Phase 3 Trial of Remternetug for Early Alzheimer's Disease ...

This study aims to determine if remternetug can slow the progression of Alzheimer's disease by targeting deposited amyloid plaques in the brain.

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07056309

A Study of Remternetug (LY3372993) in Healthy Participants

Also called a data safety ... A Study on Pharmacokinetics of Remternetug Administered Subcutaneously Through an Autoinjector Versus Prefilled Syringe in Healthy ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05463731

NCT05463731 | A Study of Remternetug (LY3372993) in ...

The reason for this study is to collect safety and efficacy information regarding the study drug remternetug in participants with early symptomatic Alzheimer's ...

8.

withpower.com

withpower.com/trial/phase-1-healthy-subjects-hs-5-2025-6c61a

Remternetug for Healthy Subjects · Info for Participants

This trial is for healthy individuals who are interested in participating in a study to compare two different ways of administering a drug called Remternetug.

9.

clinicaltrials.eu

clinicaltrials.eu/inn/remternetug/

Remternetug – Application in Therapy and Current Clinical ...

Some trials are testing remternetug delivery via an autoinjector or a prefilled syringe for subcutaneous administration. The dosing schedule varies by trial ...