Effects of LY3848575 Versus Placebo in Participants With Painful Distal Sensory Polyneuropathy

Launched by ELI LILLY AND COMPANY · Aug 21, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called LY3848575 to see how safe and effective it is for people experiencing painful nerve pain, specifically in the feet and legs. This kind of pain is known as distal sensory polyneuropathy (DSP), which means it affects the nerves that carry information from the skin and muscles to the brain. The study will compare LY3848575 to a placebo, which is an inactive substance that doesn't contain any medicine. Participants may be involved in the trial for up to 30 weeks, including a screening period to determine eligibility.

To participate, individuals should be between the ages of 65 and 74 and must have a specific level of pain that meets the study's criteria. They should have been experiencing this nerve pain for at least six months and have a known cause for it. Participants will also need to continue any regular pain relief treatments they are already using while avoiding new ones during the study. It’s important for potential participants to know that certain medical conditions or recent treatments may prevent them from joining the trial. Overall, this study aims to find better ways to help manage this type of nerve pain, which can significantly impact daily life.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Have a Visual Analog Scale (VAS) pain value ≥40 and \<95 at screening.
• • Presence of painful distal sensory polyneuropathy (DSP) without prominent motor or autonomic features with gradual or insidious onset with a minimum duration of 6 months and a known cause of nerve injury, such as metabolic, toxic exposure, nutritional, immunologic, infectious, hereditary, multifactorial, or no known cause identified (idiopathic), of symmetrical nature and in lower extremities (with or without involvement of the hands).
• • Are willing to maintain a consistent regimen of any ongoing nonpharmacologic pain- relieving therapies and/or nutritional supplements and will not start any new nonpharmacologic pain-relieving therapies and/or nutritional supplements during study participation.
• • Are willing to discontinue all medications taken for chronic pain conditions, except the allowed pain medications.
• • Individuals NOT of childbearing potential may participate in the trial. Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• Exclusion Criteria:
• • Other etiologies of pain that may not be due to DSP or confound the assessment due to painful DSP.
• • Have had a procedure within the past 6 months intended to produce permanent sensory loss in the target area of interest.
• • Have not achieved glycemic control on a stable diabetes treatment regimen for at least 90 days prior to screening, have a healthcare provider who manages the participants' diabetes, and have a hemoglobin A1c (HbA1c) \>11% at screening.
• * Cancer within 2 years of baseline, except for:
• • cutaneous basal cell or squamous cell carcinoma resolved by excision, or
• • cancer treatment which led to chemotherapy that caused distal sensory polyneuropathy.
• • Are, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide.
• • Have a surgery planned during the study for any reason.
• • History of chronic alcohol, illicit drug, or narcotic use disorder within 2 years prior to screening.