Phase 2
N=125
Chronic Pain Master Protocol (CPMP): A Study of LY3016859 in Participants With Diabetic Peripheral Neuropathic Pain
Diabetic Peripheral Neuropathic Pain
Bottom Line
View on ClinicalTrials.gov: NCT04476108 ↗Enrolled (actual)
125
Serious AEs
4.0%
Results posted
Aug 2022
Primary outcome: Primary: Change From Baseline in Average Pain Intensity as Measured by the NRS — -1.98; -1.56 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LY3016859 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Average Pain Intensity as Measured by the NRS |
-1.98; -1.56 | — |
| SECONDARY Change From Baseline in the Brief Pain Inventory-Short Form (BPI-SF) Total Interference Score |
-2.11; -1.74 | — |
| SECONDARY Change From Baseline for Overall Improvement as Measured by Patient's Global Impression of Change |
2.48; 2.75 | — |
| SECONDARY Change From Baseline for Worst Pain Intensity as Measured by NRS |
-2.10; -1.66 | — |
| SECONDARY Change From Baseline on the Visual Analog Scale (VAS) for Pain |
-26.17; -23.31 | — |
| SECONDARY Change From Baseline Assessment to Endpoint on the Sleep Scale From the Medical Outcomes Study (MOS Sleep Scale) |
0.21; -0.14 | — |
| SECONDARY Total Amount of Rescue Medication Use as Measured by Average Dosage Per Week |
271.58; 271.24 | — |
| SECONDARY Change From Baseline on the EuroQol-5D 5 Level Questionnaire (EQ-5D-5L) (United States) |
0.07; 0.03 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Have a visual analog scale (VAS) pain value ≥40 and 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.
- Are, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide.
- 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.
- Have an estimated glomerular filtration rate (eGFR) of less than 70 milliliters/minute/1.73m² during screening.
- Have any clinically serious or unstable cardiovascular, musculoskeletal disorder, gastrointestinal, endocrinologic, hematologic, hepatic, metabolic, urologic, pulmonary, dermatologic, immunologic, or ophthalmologic disease within 3 months of baseline.
- Have megaloblastic anemia or combined degeneration of the spinal cord.
- Have received any antibodies against nerve growth factor (NGF), or antibodies against EGFR, or EGFR tyrosine kinase inhibitors.
- Have a history of allergic reactions to monoclonal antibodies, or clinically significant multiple or severe drug allergies, including but not limited to erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis.
- Have a history or presence of uncontrolled asthma, eczema, significant atopy, significant hereditary angio-edema or common variable immune deficiency.
- Have fibromyalgia
Data sourced from ClinicalTrials.gov (NCT04476108). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.