Recruiting NCT07285018
A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Diabetic Peripheral Neuropathic Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LY4065967, Placebo.
- Who it may be relevant to
- Registry conditions: Diabetic Peripheral Neuropathic Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Puerto Rico
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Randomized, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate LY4065967 for the Treatment of Diabetic Peripheral Neuropathic Pain
Overview
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.
Interventions
- Drug LY4065967
Administered orally - Drug Placebo
Administered orally
Primary outcome measures
- Change from Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS) [Time frame: Baseline, Week 8]
Secondary outcome measures (6)
- Change From Baseline in the Brief Pain Inventory-Short Form Modified (BPI-SFM) Total Pain Interference Score [Time frame: Baseline, Week 8]
- Change from Baseline in Overall Improvement as Measured by Patient's Global Impression of Change (PGI-C) [Time frame: Baseline, Week 8]
- Change from Baseline in Worst Pain Intensity as Measured by NRS [Time frame: Baseline, Week 8]
- Change from Baseline in Sleep Scale from the Medical Outcomes Study (MOS Sleep Scale) [Time frame: Baseline, Week 8]
- Change from Baseline in Emotional Functioning as Measured by the EuroQol-5D 5 Level Questionnaire (EQ 5D 5L) [Time frame: Baseline, Week 8]
- Total Amount of Rescue Medication Used Daily During the Treatment Phase [Time frame: Week 8]
Eligibility criteria
Inclusion criteria
- 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 on Michigan Neuropathy Screening Instrument (©University of Michigan)
- 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)
Exclusion criteria
- 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 neuropathic pain (DPNP)
- 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 abnormalities, or any other conditions that could predispose to arrhythmia in the judgement of the investigator
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 36 centers
- Central Research Associates — Birmingham
- Synexus Clinical Research US, Inc. — Phoenix
- Arizona Research Center — Phoenix
- Desert Oasis Healthcare Medical Group — Palm Springs
- Artemis Institute for Clinical Research — Riverside
- Artemis Institute for Clinical Research — San Diego
- CMR of Greater New Haven — Hamden
- Bradenton Research Center, Inc. — Bradenton
- … and 28 more centers
Puerto Rico · 1 center
- Ponce Medical School Foundation Inc. — Ponce
Identifiers
NCT: NCT07285018 · 27370 · H0P-MC-NP07 · H0P-MC-CPMP