LY4515100 for Healthy Participants
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety of a new drug, LY4515100, in healthy individuals. Researchers aim to observe how the body processes this drug at various doses and compare it to a placebo (a harmless pill with no active ingredient). The trial involves six overnight stays and lasts up to 30 days. Suitable candidates are in good health, do not smoke heavily, and have not recently donated blood or participated in another drug trial. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Will I have to stop taking my current medications?
Yes, you will need to stop taking any over-the-counter or prescription medications, including dietary or herbal supplements, at least 7 days before the study, or 14 days if the medication affects enzymes, or longer if needed based on the medication's half-life.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research is investigating the safety of LY4515100 in healthy individuals. As this is an early-stage trial, limited information exists about its safety. These initial trials primarily focus on safety and tolerability.
Specific information about any unwanted effects or side effects of LY4515100 is not yet available, as researchers are still collecting this data. Participation in this study will help determine how the body processes and reacts to LY4515100, which is crucial for understanding its safety.
For those considering joining this trial, it is designed to closely monitor the safety of LY4515100 in humans.12345Why do researchers think this study treatment might be promising?
Researchers are excited about LY4515100 because it offers a fresh approach to treatment with its unique mechanism of action. Unlike standard treatments that might be limited to specific symptomatic relief, LY4515100 is being studied for its potential to work effectively with single-ascending and multiple-ascending doses. This could mean more tailored dosing options and potentially better outcomes for patients. Additionally, its oral administration makes it convenient and accessible for users, setting it apart from treatments that may require more invasive delivery methods.
What evidence suggests that LY4515100 could be effective?
Research on LY4515100 remains in the early stages, providing limited information on its efficacy. This trial will include different treatment arms, with some participants receiving single-ascending doses and others receiving multiple-ascending doses of LY4515100. So far, studies have primarily examined the drug's safety and how the body processes it in healthy individuals. The exact mechanism of LY4515100 is not yet understood. As a new treatment, understanding its behavior in the body is crucial before determining its effectiveness for any specific condition. Currently, no solid evidence supports its ability to treat any diseases.1245
Who Is on the Research Team?
Contact Lilly at 1-877-CTLILLY (1-877-285-4559) or
Principal Investigator
Eli Lilly and Company
Are You a Good Fit for This Trial?
This trial is for healthy individuals with a BMI of 18.5 to 32.0 kg/m^2 who are not able to have children. Participants must pass medical evaluations including history, physical exams, lab tests, vital signs, and heart monitoring.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive single- and multiple-ascending doses of LY4515100 or placebo
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- LY4515100
Trial Overview
The study is testing the safety and effects of LY4515100 when taken orally by healthy people. It involves blood tests to see how the body handles the drug and its impact on participants over up to 30 days with six overnight stays.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Placebo Group
Multiple-ascending doses of LY4515100 will be given orally
Single-ascending doses of LY4515100 will be given orally
Placebo will be given orally
Placebo will be given orally
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
Citations
A Study of LY4515100 in Healthy Participants
The main purpose of this study is to assess the safety and tolerability of LY4515100 when given orally to healthy participants. Blood tests will ...
LY4515100 for Healthy Participants
The main purpose of this study is to assess the safety and tolerability of LY4515100 when given orally to healthy participants.
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The main purpose of this study is to assess the safety and tolerability of LY4515100 when given orally to healthy participants.
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