123 Participants NeededMy employer runs this trial

LY4355756 for Healthy Participants

Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Eli Lilly and Company
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called LY4355756 to determine its absorption and safety in healthy individuals. The trial consists of different parts, where participants receive either a single dose or multiple doses, sometimes alongside another drug, midazolam. Healthy individuals with no major health issues and a body mass index (BMI) between 18.0 and 32.0 kg/m² may qualify to participate. Participants must stay at the clinical research unit for several days during the trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the unique opportunity to be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, since the study is for healthy participants, it's possible that taking medications might affect eligibility. It's best to discuss your specific situation with the trial organizers.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

In the absence of specific safety data for LY4355756, a few key points can be considered. This study is in its early phase, focusing primarily on assessing the treatment's safety for participants. Early-phase trials typically involve small groups to evaluate how well they tolerate the new treatment.

Regarding the combination of LY4355756 and midazolam, midazolam is a well-known medication often used to alleviate anxiety or induce sleep before surgeries. It is generally well-tolerated but can cause side effects such as drowsiness or dizziness.

Without clear data, determining the exact safety of LY4355756 is challenging. However, early-phase trials are designed to monitor closely for any side effects to ensure participant safety. If the treatment progresses to later phases, it indicates that initial studies have found it reasonably safe.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about LY4355756 because it offers a potentially novel approach to treatment, differing from traditional therapies. Unlike most treatments that rely on well-established pathways, LY4355756's mechanism of action is unique and still under investigation, promising new insights into its effectiveness. The study involves different dosing strategies, such as single-ascending and multiple-ascending doses, which could optimize its use and efficacy. Additionally, the co-administration with midazolam aims to explore potential synergistic effects or interactions, which could enhance therapeutic outcomes. This multifaceted investigation provides a fresh perspective on treatment possibilities and may lead to innovative solutions for patients.

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

Research on LY4355756 remains in the early stages, so limited information exists about its effectiveness for specific conditions. This trial includes several treatment arms to evaluate different dosing strategies: Part A involves a single-ascending dose, Part B involves multiple-ascending doses, and Part C involves a single dose administered in each of three study periods. Additionally, Part D examines the co-administration of LY4355756 with midazolam, as well as midazolam alone. The study primarily focuses on how the drug is absorbed in healthy individuals and assesses its safety. Without clear evidence of its effectiveness, the main goal is to understand how the drug behaves in the body. This information may support future studies on its potential benefits for certain conditions.678910

Who Is on the Research Team?

C1

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 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 adults who do not have any significant medical conditions. Participants must be willing to stay at the research center for several days during different parts of the study.

Inclusion Criteria

Are overtly healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, electrocardiogram (ECGs), and vital signs
Have a body mass index within the range 18.0-32.0 kilograms per square meter (kg/m²) inclusive
Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
See 1 more

Exclusion Criteria

I have received a vaccine within the last 4 weeks or plan to get one during the study.
Have an abnormality in 12-lead ECG at screening that may increase risk or confound ECG data analysis
I do not have any serious uncontrolled health problems or abnormal lab results.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Part A - Single-ascending dose

Participants receive a single-ascending dose of LY4355756 administered orally

5 days
1 inpatient stay (5 continuous days)

Part B - Multiple-ascending doses

Participants receive multiple-ascending doses of LY4355756 administered orally

22 days
1 inpatient stay (22 continuous days)

Part C - Single dose in three periods

Participants receive a single dose of LY4355756 administered orally in each of three study periods

15 days
3 inpatient stays (5 continuous days each)

Part D - Co-administration with Midazolam

Participants receive LY4355756 and midazolam co-administered orally

18 days
1 inpatient stay (18 continuous days)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • LY4355756

Trial Overview

The study is testing a new drug called LY4355756 and how it is absorbed in the body, as well as its safety. Some participants will also receive midazolam to see if there are interactions between the two drugs.

How Is the Trial Designed?

5

Treatment groups

Experimental Treatment

Group I: Midazolam Part DExperimental Treatment1 Intervention
Group II: LY4355756 Part CExperimental Treatment1 Intervention
Group III: LY4355756 Part BExperimental Treatment1 Intervention
Group IV: LY4355756 Part AExperimental Treatment1 Intervention
Group V: LY4355756 + Midazolam Part DExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Citations

Midazolam clinical trials: 53 current studies and sponsors

Evaluating the Efficacy and Safety. A Study of LY4355756 in Healthy Participants. Apr 2014 Midazolam Hydrochloride InjectionUS (FDA) This page ...

Paid Clinical Trials Texas - Texas Clinical Trials - Page 32

Texas offers a wide range of paid research opportunities for both healthy volunteers and individuals with specific health conditions. ... LY4355756. for.

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The journal covers the physics and engineering of safety; its social, policy and organizational aspects; the assessment, management and communication of risks;

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The story of Ray-Ray McElrathbey, a freshman football player for Clemson University who secretly raised his younger brother on campus after his home life ...

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This course aims to instill safety awareness and habits so that real estate professionals and their clients/customers will always remain safe.