Chronic Pain Master Protocol (CPMP): A Study of LY3526318 in Participants With Diabetic Peripheral Neuropathic Pain

Phase 2

Completed

Conditions: Diabetic Peripheral Neuropathic Pain

Interventions: Drug: Placebo
Drug: LY3526318

Registration Number: NCT05177094

Lead Sponsor: Eli Lilly and Company

Brief Summary: The purpose of this study is to test the safety and efficacy of study drug LY3526318 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 155

Inclusion Criteria

Have a visual analog scale (VAS) pain value ≥40 and <95 during screening.
Have a history of daily pain for at least 12 weeks based on participant report or medical history.
Have a body mass index <40 kilograms per meter squared (kg/m²) (inclusive).
Are willing to maintain a consistent regimen of any ongoing nonpharmacologic pain-relieving therapies (for example, physical therapy) and will not start any new nonpharmacologic pain-relieving therapies during study participation.
Are willing to discontinue all pain medications taken for chronic pain conditions for the duration of the study.
Have daily symmetrical foot pain secondary to peripheral neuropathy present for at least 6 months and as diagnosed through use of the Michigan Neuropathy Screening Instrument Part B ≥3 (©University of Michigan).
Have a history and current diagnosis of type 1 or type 2 diabetes mellitus.
Have stable glycemic control as indicated by a glycated hemoglobin ≤11 at time of screening.
Are men, or women able to abide by reproductive and contraceptive requirements.

Exclusion Criteria

Have had a procedure within the past 6 months intended to product permanent sensory loss in the target area of interest (for example, ablation techniques).
Have surgery planned during the study for any reason, related or not the disease state under evaluation.
Have, in the judgment of the investigator, an acute, serious, or unstable medical condition or a history or presence of any other medical illness that would preclude study participation.
Have a substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (5th edition; DSM-5; American Psychiatric Association).
Have had cancer within 2 years of baseline, except for cutaneous basal cell or squamous cell carcinoma resolved by excision.
Have fibromyalgia
Are, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide.
Have a positive human immunodeficiency virus (HIV) test result at screening.
Have an intolerance to acetaminophen or paracetamol or any of its excipients.
Have a history of alcohol, illicit drug, analgesic or narcotic use disorder within 2 years prior to screening.
Have a current drug-induced neuropathy, for example, due to some types of chemotherapy, or other types of peripheral neuropathy.
Have known hereditary motor, sensory or autonomic neuropathies.
Are pregnant or breastfeeding.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants received placebo orally, once daily, for 8-weeks treatment period.
LY3526318	LY3526318	Participants received 250 milligram (mg) of LY3526318 orally, once daily for the first 4 weeks and were switched to placebo once daily for the next 4 weeks of the treatment period.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)	Baseline, Week 8	The NRS was used to describe pain severity. Participants were asked to describe their average pain over the past 24 hours, on a scale of 0 to 10: 0=no pain, and 10=pain as bad as you can imagine. Posterior mean change from baseline, 95% credible intervals was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.

Secondary Outcome Measures

Name	Time	Method
Total Amount of Rescue Medication Use as Measured by Average Daily Dosage	Week 8	Total amount of rescue medication use as measured by average daily dosage. Posterior mean, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.
Change From Baseline on the EuroQuality of Life Five Dimensions (5D) Five Level (5L) Questionnaire (EQ-5D-5L) Health State Index (United States Algorithm)	Baseline, Week 8	The EQ-5D-5L assessed quality of life based on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant was asked to 'check the ONE box that best describes your health TODAY,' choosing from 5 options (no problems, slight problems, moderate problems, severe problems, extreme problems) provided under each dimension. The scores in the 5 dimensions were summarized into a health state index score using the United States algorithm. The health state index value is a single value on a scale from less than 0 to 1 (negative values are valued as worse than dead) with higher scores indicating better health: 0=a health state equivalent to death, and 1=perfect health. Posterior mean change from baseline, 95% credible intervals was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.
Change From Baseline in the Brief Pain Inventory-Short Form Modified (BPI-SFM) Total Pain Interference Score	Baseline, Week 8	The BPI-SFM is a numeric rating scale that assesses the severity of pain (severity scale) and its impact on daily functioning (Pain Interference scale). BPI-SFM pain interference scale has been reported here. Pain interference scale has 7 items, including general activity, mood, walking ability, normal work, relations with others, sleep, and enjoyment of life each assessed on a 10-point scale. All the 7-items are averaged to produce a total score ranging from 0 to 10 where, 0=does not interfere to 10=completely interferes and the mean is reported here. Higher score represents worse outcome. Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.
Change From Baseline for Overall Improvement as Measured by Patient's Global Impression of Change	Baseline, Week 8	Patients Global Impression of change captured the participant's perspective of treatment apart from sub-aspects of the general improvement. This is a numeric scale from 1 to 7: 1=very much better, and 7=very much worse. Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.
Change From Baseline for Worst Pain Intensity as Measured by NRS	Baseline, Week 8	The NRS was used to describe pain severity. Participants were asked to describe their worst pain over the past 24 hours, on a scale of 0 to 10: 0=no pain, and 10=pain as bad as you can imagine. Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.
Change From Baseline on the Visual Analog Scale (VAS) for Pain	Baseline, Week 8	VAS was a graphic, single-item scale where participants were asked to describe their pain intensity over the past week, on a scale of 0 to 100: 0=no pain, and 100=worst imaginable pain. Participants completed the VAS by placing a line perpendicular to the VAS line at a point that described their pain intensity. Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.
Change From Baseline on the Sleep Scale From the Medical Outcomes Study (MOS Sleep Scale) - Average Hours of Sleep	Baseline, Week 8	The MOS Sleep Scale consists of 12 questions addressing the past week. Question 1 asks time to fall asleep and it is reported in 5-point timeframe categories. Question 2 asks average hours of sleep. In the remaining 10 questions participants report how often a sleep symptom or problem was present on a scale ranging from '0=all of the time' to '5=none of the time.' MOS Sleep scale dimension scores range from 0 to 100 with lower score indicating improvement, except for the dimension of sleep adequacy, where higher scores indicate improvement. Here, the average hours of sleep (i.e., Question 2) is reported as the average number of hours slept each night during the past week (range 0 to 24 hours). Higher number of hours slept indicates improvement. Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.

Trial Locations

Locations (33): Synexus Clinical Research US, Inc - Orlando
🇺🇸
The Villages, Florida, United States
Northwest Clinical Research Center
🇺🇸
Bellevue, Washington, United States
Rainier Clinical Research Center
🇺🇸
Renton, Washington, United States
NorthShore University HealthSystem
🇺🇸
Skokie, Illinois, United States
StudyMetrix Research
🇺🇸
Saint Peters, Missouri, United States
FutureSearch Trials
🇺🇸
Austin, Texas, United States
Synexus - US
🇺🇸
San Antonio, Texas, United States
Great Lakes Research Group, Inc.
🇺🇸
Bay City, Michigan, United States
Northwestern University
🇺🇸
Chicago, Illinois, United States
Clinvest Research LLC
🇺🇸
Springfield, Missouri, United States
Cedar Health Research
🇺🇸
Dallas, Texas, United States
ActivMed Practices and Research
🇺🇸
Methuen, Massachusetts, United States
MedVadis Research Corporation
🇺🇸
Waltham, Massachusetts, United States
Alliance for Multispecialty Research, LLC Tempe
🇺🇸
Tempe, Arizona, United States
VIN-Julie Schwartzbard
🇺🇸
Aventura, Florida, United States
Boston Clinical Trials
🇺🇸
Boston, Massachusetts, United States
Synexus Clinical Research - Glendale
🇺🇸
Glendale, Arizona, United States
Renstar Medical Research
🇺🇸
Ocala, Florida, United States
North Georgia Clinical Research
🇺🇸
Woodstock, Georgia, United States
META Medical Research Institute
🇺🇸
Dayton, Ohio, United States
Altoona Center For Clinical Research
🇺🇸
Duncansville, Pennsylvania, United States
Artemis Institute for Clinical Research
🇺🇸
San Diego, California, United States
Suncoast Research Group
🇺🇸
Miami, Florida, United States
Synexus - Cincinnati
🇺🇸
Cincinnati, Ohio, United States
University of Miami Don Suffer Clinical Research Building
🇺🇸
Miami, Florida, United States
New Horizon Research Center
🇺🇸
Miami, Florida, United States
Rocky Mountain Clinical Research
🇺🇸
Idaho Falls, Idaho, United States
Arizona Research Center
🇺🇸
Phoenix, Arizona, United States
Ponce Medical School Foundation Inc.
🇵🇷
Ponce, Puerto Rico
Synexus Clinical Research US, Inc.
🇺🇸
Chicago, Illinois, United States
CMR of Greater New Haven
🇺🇸
Hamden, Connecticut, United States
Joslin Diabetes Center
🇺🇸
Boston, Massachusetts, United States
Latin Clinical Trial Center
🇵🇷
San Juan, Puerto Rico