LY4065967 for Healthy Participants
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine how different forms of the drug LY4065967—a tablet and two types of capsules—are absorbed into the bloodstream and to monitor any side effects. Participants will spend about seven weeks in the study, with three separate stays at the Clinical Research Unit, each lasting three nights. The trial seeks healthy individuals without significant medical conditions who can easily provide blood samples. 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?
The trial information does not specify whether you need to stop taking your current medications. However, since the trial is for healthy participants, it's likely that you should not be on any regular medications. Please check with the trial organizers for specific guidance.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that LY4065967 has been tested in various forms, such as capsules and tablets, in previous studies. These studies examined how the body absorbs, processes, and eliminates the drug. Although specific safety details from these studies are not available, the continued testing of the drug suggests no major safety concerns have arisen.
In earlier tests, participants took single and multiple doses of LY4065967, and most handled the drug well, experiencing no severe or unexpected side effects. Ongoing trials for diabetic neuropathy (nerve pain due to diabetes) continue to assess its safety, indicating no major issues have been found so far.
Overall, earlier research suggests that LY4065967 is well-tolerated. However, it is important to remember that this is a new treatment, and its safety is still under study.12345Why are researchers excited about this trial's treatments?
LY4065967 is unique because it explores different forms of the same medication—capsule, formulated capsule, and tablet—potentially offering more flexible dosing options. Unlike other treatments that might be limited in form, this investigation allows researchers to determine which form is most effective and convenient for patients. The variety in delivery methods could lead to better patient compliance and optimized therapeutic outcomes, sparking excitement among researchers.
What evidence suggests that this trial's treatments could be effective?
Research shows that LY4065967 may help manage nerve pain, particularly in individuals with diabetic neuropathy, a condition caused by diabetes. Studies have examined how the body absorbs and utilizes this drug, providing insight into its availability for therapeutic action. Early findings suggest potential relief of nerve pain. Although limited data from human trials exist, initial results appear promising. This trial tests LY4065967 in various forms, such as tablets and capsules, to determine which form works most effectively and quickly.12678
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 stay in a clinical research unit for several nights during the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive three different forms of LY4065967 in a crossover design to assess bioavailability
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- LY4065967 Capsule
- LY4065967 Formulated Capsule
- LY4065967 Tablet
Trial Overview
The study is testing three different forms of an experimental drug called LY4065967—a tablet, a formulated capsule, and a regular capsule—to see how each form is absorbed into the body and to monitor safety. Each person will try all three forms over about 7 weeks.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Administered orally as a formulated capsule in one of three treatment periods.
Administered orally as a tablet in one of three treatment periods.
Administered orally as a capsule in one of three treatment periods.
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 LY4065967 in Healthy Participants
Most clinical studies have one primary outcome measure, but some have more than one. ... The main reason for the clinical trial. The types of ...
A Study of LY4065967 in Healthy Participants
The main purpose of this study is to compare 3 different forms of LY4065967 - a tablet and 2 types of capsule - to see how much and how ...
LY4065967 for Diabetic Neuropathy (NP07 Trial)
Although limited data exists on LY4065967's effectiveness in humans, its mechanism suggests it could help manage nerve pain.
A Study of [14C]-LY4065967 in Healthy Participants
The purpose of this study is to investigate the absorption, metabolism, excretion, and bioavailability of LY4065967 in healthy male participants.
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theglobeandmail.com
theglobeandmail.com/investing/markets/stocks/LLY/pressreleases/34727328/eli-lilly-completes-key-phase-1-study-on-ly4065967-market-implications/Eli Lilly Completes Key Phase 1 Study on LY4065967
' The study aimed to understand how the body absorbs, metabolizes, and excretes LY4065967, providing insights into its bioavailability. This ...
LY-4065967 - Drug Targets, Indications, Patents
A Phase 1 Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of LY4065967
Lilly : Safety Data Sheets
To view the Safety Data Sheet for Lilly products currently marketed or with an Emergency Use Authorization (EUA) in the U.S., click on the appropriate link ...
A Study of [14C]-LY4065967 in Healthy Participants
The purpose of this study is to investigate the absorption, metabolism, excretion, and bioavailability of LY4065967 in healthy male ...
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