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LY4065967 for Healthy Participants

No longer recruiting at 1 trial location
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Overseen ByPhysicians interested in becoming principal investigators please contact
Age: 18 - 65
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 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.12345

Why 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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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 should be generally well and able to stay in a clinical research unit for several nights during the study.

Inclusion Criteria

I have veins suitable for regular blood draws.
Have an electrocardiogram (ECG) at screening considered to be within acceptable limits by the investigator
Are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests
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Exclusion Criteria

Have a history of clinically significant known allergies to LY4065967, related compounds, or any components of the formulation, or history of significant atopy
Have a history of or current clinically significant medical conditions including cardiovascular disease, electrolyte abnormalities, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurologic disorders that could predispose to arrhythmia, pose a risk with study participation, significantly alter the absorption, metabolism, or elimination of the study drug, or interfere with the interpretation of study data
Have systolic blood pressure of 140 millimeters of mercury (mmHg) or greater and diastolic blood pressure of 90 mmHg or greater at screening
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive three different forms of LY4065967 in a crossover design to assess bioavailability

7 weeks
3 stays in the Clinical Research Unit, each lasting 3 nights

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

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

Group I: LY4065967 (Test 2)Experimental Treatment1 Intervention
Group II: LY4065967 (Test 1)Experimental Treatment1 Intervention
Group III: LY4065967 (Reference)Experimental Treatment1 Intervention

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

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.

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

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ehs.lilly.com

ehs.lilly.com/

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 ...