Remternetug for Healthy Subjects
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.12345Why 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.56789
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single subcutaneous administration of remternetug using either an autoinjector or a prefilled syringe
Follow-up
Participants are monitored for pharmacokinetics and safety after administration
What Are the Treatments Tested in This Trial?
Interventions
- Remternetug
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eli Lilly and Company
Lead Sponsor
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