LY4178256 for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to evaluate how well the new treatment, LY4178256 (an experimental treatment), is tolerated by healthy individuals and to identify any side effects. Researchers will conduct blood tests to understand how the body processes the drug. Participants will visit the study site multiple times over approximately 7 months. This trial suits individuals who are generally healthy and meet specific health criteria, such as having a body mass index between 19 and 32 kg/m². As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Is there any evidence suggesting that LY4178256 is likely to be safe for humans?
Research shows that LY4178256 is being tested to assess its tolerability and identify any side effects. So far, studies have focused on healthy participants to determine if the treatment causes any serious problems. However, because this treatment is still in early testing, detailed safety information remains limited.
In these early trials, researchers aim to understand how the body processes the drug. They examine how much of the drug enters the bloodstream and how long it remains there. Although specific details about side effects are not yet available, the goal is to identify any issues early. This trial phase ensures the treatment is safe for humans before progressing to larger studies.12345Why are researchers excited about this trial's treatments?
LY4178256 is unique because it utilizes a novel mechanism of action that hasn't been explored in current treatments, potentially offering a fresh approach to managing the condition. Unlike standard treatments, which might involve oral medications or injections targeting different pathways, LY4178256 is administered intravenously and may provide more direct and potent effects. Researchers are particularly excited about its potential to deliver results quickly and efficiently, offering a new avenue for treatment that could improve patient outcomes significantly.
What evidence suggests that LY4178256 could be effective?
Currently, specific information on how well LY4178256 works for any particular health condition is unavailable. This trial includes two parts: Part A involves a Single-Ascending Dose (SAD) of LY4178256 or placebo, and Part B involves a Multiple Ascending Dose (MAD) of LY4178256 or placebo. So far, studies have mainly examined how well people tolerate the treatment and its potential side effects. Researchers are still learning about how LY4178256 functions in the body. Without information on its use for specific health issues, its effectiveness remains undetermined until further research is conducted.16789
Who Is on the Research Team?
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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 should be generally well and able to attend several study visits over about 7 months.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Single-Ascending Dose (SAD) Treatment
Participants receive a single ascending dose of LY4178256 or placebo administered intravenously
Multiple Ascending Dose (MAD) Treatment
Participants receive multiple ascending doses of LY4178256 or placebo administered intravenously
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- LY4178256
Trial Overview
The study is testing a new drug called LY4178256 compared to a placebo (inactive substance) in healthy people. It looks at how the body processes the drug and checks for side effects, with participants randomly assigned to each group.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
LY4178256 or Placebo administered IV
LY4178256 or Placebo administered Intravenously (IV)
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
Effectiveness of school-based health promotion interventions ...
We examined randomized controlled trial (RCT) studies to obtain information about the unit of randomization and the number of intervention and control groups.
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preprod-preview.ovid.com
preprod-preview.ovid.com/jnls/jphmp/fulltext/10.1097/phh.0000000000002350~implementation-outcomes-and-impact-of-a-school-health-andImplementation Outcomes and Impact of a School Health ...
Implementation outcome measures number of criteria ranged from 34 to 42 across years. The overall Healthy CPS score was computed as the average percentage of ...
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trial.medpath.com
trial.medpath.com/clinical-trial/1541b42476669021/nct07698210-ly4178256-safety-tolerability-pharmacokinetics-healthy-participantsA Study of LY4178256 in Healthy... | Clinical Trial
The main purpose of this study is to evaluate how well LY4178256 is tolerated and what side effects may occur in healthy participants.
4.
ctdatahaven.org
ctdatahaven.org/wp-content/uploads/2025/12/Edu-School-Health-Academic-ResearchReview-WADH-09-09.pdfResearch Review: School-based Health Interventions and ...
Data from the Healthy Youth. Survey in Washington State provide a new way of looking at the relationship between health risk and academic achievement. The ...
A Study of LY4178256 in Healthy Participants
The main purpose of this study is to evaluate how well LY4178256 is tolerated and what side effects may occur in healthy participants.
Safety, Tolerability, Pharmacokinetics, and ...
This phase 1 study aims to evaluate the safety and tolerability of LY4178256 in healthy participants, focusing on identifying any serious adverse events
Drug Safety and Availability
Information for consumers and health professionals on new drug warnings and other safety information, drug label changes, and shortages of ...
Safety Data Sheets
Pfizer develops Safety Data Sheets (SDSs) for our products. We prepare, maintain, and provide the SDSs
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theglobeandmail.com
theglobeandmail.com/investing/markets/stocks/LLY-N/pressreleases/3973166/eli-lillys-new-phase-1-study-of-ly4178256-advances-its-drug-pipeline/Eli Lilly's New Phase 1 Study of LY4178256 Advances Its ...
It is being tested against a placebo to see how well healthy volunteers tolerate it and to gather early data that could guide future trials in ...
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