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New treatment option for Diabetic Peripheral Neuropathic Pain
Official title A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Diabetic Peripheral Neuropathic Pain
ClinicalTrials.gov ID: NCT07285018
What this study is testing
What is LY4065967?
LY4065967 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for diabetic peripheral neuropathic pain.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 trial is part of the chronic pain master protocol H0P-MC-CPMP (NCT05986292) which is a protocol to accelerate the development of new treatments for chronic pain.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Have presence of diabetic peripheral neuropathy, of symmetrical nature and in lower extremities for ≥6 months and diagnosed by a score of Part B ≥3...
- Have a history and current diagnosis of type 1 or type 2 diabetes mellitus.
- Have an HbA1c \<11% and on a stable regimen for treatment of diabetes at least 90 days prior to screening
- Have a body mass index at screening of ≤40 kilogram per meter squared (kg/m2)
You likely can't join if
- Are pregnant or breastfeeding
- Have a history of other potentially causative and/or confounding sources of pain that may impair self-assessment of pain due to diabetic peripheral...
- Have lower limb amputation due to diabetes inclusive of great toe (metatarsal bone)
- Have serum vitamin B12 ≤200 picogram per milliliter (pg/mL)
- Have an abnormal BP (systolic BP \>140 mm Hg and diastolic BP\>90 mm Hg) at screening
- Have history or current clinically significant cardiac disease, including arrhythmia, aortic aneurysm, heart failure, current electrolyte...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- Palm Springs, California, United States
- Riverside, California, United States
- San Diego, California, United States
- Hamden, Connecticut, United States
- Bradenton, Florida, United States
- DeLand, Florida, United States
- Lady Lake, Florida, United States
- Maitland, Florida, United States
- Merritt Island, Florida, United States
- Miami, Florida, United States
- New Port Richey, Florida, United States
- Ocala, Florida, United States
- Sunrise, Florida, United States
- The Villages, Florida, United States
- Winter Park, Florida, United States
- Woodstock, Georgia, United States
- Chicago, Illinois, United States
- New Orleans, Louisiana, United States
+ 15 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Phoenix, Arizona, United States; Palm Springs, California, United States; Riverside, California, United States; San Diego, California, United States; Hamden, Connecticut, United States and 29 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.