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

JRCT ID: jRCT2051240131

Registered date:19/09/2024

Basic Information

• Recruitment status: Recruiting

Health condition(s) or Problem(s) studied

Neuropathic Pain
Distal Sensory Polyneuropathy

• Date of first enrollment: 15/10/2024
• Target sample size: 450
• Countries of recruitment: United States,Japan,Canada,Japan,Czechia,Japan,Germany,Japan,Korea,Japan,Mexico,Japan,Poland,Japan
• Study type: Interventional

Intervention(s)

DRUG: LY3848575
Administered SC
DRUG: Placebo
Administered SC

[Study Arms]
Experimental: LY3848575 Dose 1
LY3848575 low dose administered subcutaneously (SC).
Interventions:
Drug: LY3848575
Experimental: LY3848575 Dose 2
LY3848575 mid dose administered SC.
Interventions:
Drug: LY3848575
Experimental: LY3848575 Dose 3
LY3848575 high dose administered SC.
Interventions:
Drug: LY3848575
Placebo Comparator: Placebo
Placebo administered SC.
Interventions:
Drug: Placebo

Outcome(s)

• Primary Outcome: Mean Change from Baseline in Average Pain Intensity Numeric Rating Scale (API-NRS) [ Time Frame: Baseline, Week 12

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Masaki Takeshi
• Secondary ID(s): NCT06568042