Randomized, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate LY3016859 for the Treatment of Diabetic Peripheral Neuropathic Pain

Eli Lilly and Company29 sites in 2 countries125 target enrollmentJuly 15, 2020

ConditionsDiabetic Peripheral Neuropathic Pain

InterventionsLY3016859 Placebo

DrugsLY3016859 Placebo

Overview

Phase: Phase 2
Intervention: LY3016859
Conditions: Diabetic Peripheral Neuropathic Pain
Sponsor: Eli Lilly and Company
Enrollment: 125
Locations: 29
Primary Endpoint: Change From Baseline in Average Pain Intensity as Measured by the NRS
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is being done to test the safety and efficacy of the study drug LY3016859 for the treatment of diabetic peripheral neuropathic pain. 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.

Registry

clinicaltrials.gov

Start Date

July 15, 2020

End Date

November 11, 2021

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Responsible Party

Sponsor

Eligibility Criteria

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 value of ≤30 on the pain catastrophizing scale.
•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 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 second- or third-degree atrioventricular (AV) heart block or AV dissociation or history of ventricular tachycardia.
•Have had a procedure within the past 6 months intended to produce 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 to 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.
•There is an inability to rule out other causative or confounding sources of pain in the primary condition under study.
•Have had cancer within 2 years of baseline, except for cutaneous basal cell or squamous cell carcinoma resolved by excision.
•Have a substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (5th edition; DSM-5; American Psychiatric Association).
•Have congenital QT prolongation or QT interval corrected for heart rate using Fridericia's formula (QTcF) interval measurement \>450 milliseconds (msec) for male participants, \>470 msec for female participants, or \>480 msec for participants with bundle branch block.
•Have any clinically important abnormality at screening, as determined by investigator, in physical or neurological examination, vital signs, electrocardiogram (ECG), or clinical laboratory test results that could be detrimental to the participant or could compromise the study.
•Have a positive human immunodeficiency virus (HIV) test result at screening.

Arms & Interventions

750 Mg-500 mg LY3016859

Participants received LY3016859 every 2 weeks with 750 mg as starting dose followed by 500 mg intravenous (IV) infusion for a total of 4 doses.

Intervention: LY3016859

Placebo

Participants received LY3016859 every 2 weeks with 750 mg as starting dose followed by 500 mg IV infusion for a total of 4 doses.

Intervention: Placebo

Outcomes

Primary Outcomes

Change From Baseline in Average Pain Intensity as Measured by the NRS

Time Frame: Baseline, up to Week 8

The NRS was used during the preliminary data entry period and daily throughout the study 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 interval (CrI) was derived using Bayesian mixed model repeated measures.

Secondary Outcomes

Change From Baseline for Overall Improvement as Measured by Patient's Global Impression of Change(Baseline, up to Week 8)
Change From Baseline Assessment to Endpoint on the Sleep Scale From the Medical Outcomes Study (MOS Sleep Scale)(Baseline, up to Week 8)
Change From Baseline for Worst Pain Intensity as Measured by NRS(Baseline, up to Week 8)
Change From Baseline in the Brief Pain Inventory-Short Form (BPI-SF) Total Interference Score(Baseline, up to Week 8)
Change From Baseline on the Visual Analog Scale (VAS) for Pain(Baseline, up to Week 8)
Total Amount of Rescue Medication Use as Measured by Average Dosage Per Week(Baseline up to Week 8)
Change From Baseline on the EuroQol-5D 5 Level Questionnaire (EQ-5D-5L) (United States)(Baseline, up to Week 8)