NCT05177094CompletedPhase 2
Randomized, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate LY3526318 for the Treatment of Diabetic Peripheral Neuropathic Pain
Eli Lilly and Company33 sites in 2 countries155 target enrollmentStarted: January 26, 2022Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 155
- Locations
- 33
- Primary Endpoint
- Change From Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
LY3526318
Experimental
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.
Intervention: LY3526318 (Drug)
Placebo
Placebo Comparator
Participants received placebo orally, once daily, for 8-weeks treatment period.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change From Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)
Time Frame: 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 Outcomes
- Total Amount of Rescue Medication Use as Measured by Average Daily Dosage(Week 8)
- 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)
- Change From Baseline in the Brief Pain Inventory-Short Form Modified (BPI-SFM) Total Pain Interference Score(Baseline, Week 8)
- Change From Baseline for Overall Improvement as Measured by Patient's Global Impression of Change(Baseline, Week 8)
- Change From Baseline for Worst Pain Intensity as Measured by NRS(Baseline, Week 8)
- Change From Baseline on the Visual Analog Scale (VAS) for Pain(Baseline, Week 8)
- Change From Baseline on the Sleep Scale From the Medical Outcomes Study (MOS Sleep Scale) - Average Hours of Sleep(Baseline, Week 8)
Investigators
Study Sites (33)
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