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

Lilly

Status and phase: Enrolling; Phase 2

Conditions: Distal Sensory Polyneuropathy; Neuropathic Pain

Treatments: Drug: Placebo; Drug: LY3848575

Study type: Interventional

Funder types: Industry

Identifiers

NCT06568042

18825 (Other Grant/Funding Number)

2024-513435-24-00 (EU Trial (CTIS) Number)

J4F-MC-CYAB (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate how safe and how well a treatment works compared to placebo for people with nerve pain that begins in their feet and moves up the leg to just below the knee.

Participation may last up to 30 weeks including screening.

Enrollment: 450 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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450 participants in 4 patient groups, including a placebo group

LY3848575 Dose 1

Experimental group

Description:

LY3848575 low dose administered subcutaneously (SC).

Treatment:

Drug: LY3848575

LY3848575 Dose 2

Experimental group

Description:

LY3848575 mid dose administered SC.

Treatment:

Drug: LY3848575

LY3848575 Dose 3

Experimental group

Description:

LY3848575 high dose administered SC.

Treatment:

Drug: LY3848575

Placebo

Placebo Comparator group

Description:

Placebo administered SC.

Treatment:

Drug: Placebo