LY4065967 for Diabetic Neuropathy
(NP07 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug, LY4065967, to see if it can reduce pain from diabetic peripheral neuropathy, a type of nerve pain affecting the legs and feet of people with diabetes. The goal is to determine the drug's safety and effectiveness in treating this chronic pain. Participants will receive either the experimental drug or a placebo, a substance with no active ingredient, to compare results. Candidates may be suitable for this trial if they have experienced diabetic nerve pain in their lower legs for at least six months and have a stable diabetes treatment plan. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that LY4065967 is likely to be safe for humans?
Research has shown that LY4065967 has undergone testing to assess its safety. These tests evaluated how well individuals tolerate both single and multiple doses. Such tests are typically the initial steps to determine if a new treatment is safe for humans. Although specific data from these studies is unavailable, the ongoing testing of LY4065967 suggests that earlier studies did not identify major safety concerns.
It is important to note that the safety of LY4065967 for treating diabetic neuropathy remains under investigation. This trial is part of a broader effort to discover new treatments for chronic pain, with a strong emphasis on safety. All treatments in clinical trials are closely monitored for any side effects.12345Why do researchers think this study treatment might be promising for diabetic neuropathy?
Most treatments for diabetic neuropathy focus on managing symptoms using pain relievers or anticonvulsants. But LY4065967 works differently, targeting the underlying nerve damage caused by diabetes. Researchers are excited about LY4065967 because it aims to not just alleviate pain, but potentially repair nerve function, providing a more comprehensive approach to treatment. This new mechanism of action could offer significant relief and improved quality of life for patients suffering from diabetic neuropathy.
What evidence suggests that LY4065967 might be an effective treatment for diabetic neuropathy?
Research has shown that LY4065967 is being tested to relieve pain from diabetic peripheral neuropathy (DPNP). This treatment blocks pain signals in the nerves, potentially reducing the painful symptoms often experienced by people with diabetes. Although limited data exists on LY4065967's effectiveness in humans, its mechanism suggests it could help manage nerve pain. Participants in this trial will receive either LY4065967 or a placebo, which could mean less pain and discomfort in daily life for those with diabetic neuropathy.12678
Who Is on the Research Team?
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 individuals with diabetic peripheral neuropathic pain, a condition causing nerve damage and pain due to diabetes. Participants should have stable diabetes management and be willing to discontinue current pain medications. Those with certain medical conditions or taking specific drugs that could interfere with the study are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive LY4065967 or placebo orally for the treatment of diabetic peripheral neuropathic pain
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- LY4065967
Trial Overview
The trial is testing LY4065967's safety and effectiveness in treating diabetic neuropathy pain compared to a placebo. It's part of a larger effort (H0P-MC-CPMP) aimed at speeding up the development of new chronic pain treatments.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive LY4065967 orally.
Participants will receive placebo 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 Chronic Pain Master Protocol (CPMP): A Study of ...
The purpose of this study is to test the safety and efficacy of study drug LY4065967 for the treatment of diabetic peripheral neuropathic pain (DPNP).
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The purpose of this study is to test the safety and efficacy of study drug LY4065967 for the treatment of diabetic peripheral neuropathic pain (DPNP). This ...
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This presentation contains forward-looking statements that are based on management's current expectations, but actual results.
A systematic review of outcomes measured in interventional ...
The symptoms of the small fibre loss include neuropathic pain, hyperalgesia and allodynia, while numbness and dysesthesia fall under large fibre loss.
LY4065967 - Drug Targets, Indications, Patents
A Phase 1 Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of LY4065967
q3 2024 earnings call
The safety and efficacy of the agents under investigation have not been established. ... Diabetic Peripheral Neuropathic Pain. 2. 410. Mean Change ...
LY-4065967 - MedPath
No Philippines FDA approvals found for this drug. Saudi SFDA Drug Approvals ...
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