Clinical trial NCT04707157: Chronic Pain Master Protocol (CPMP): A Study of LY3556050 in Participants With Diabetic Peripheral Neuropathic Pain
Official title: Randomized, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate LY3556050 for the Treatment of Diabetic Peripheral Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Diabetic Peripheral Neuropathic Pain
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2021-01-13
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is being done to test the safety and efficacy of the study drug LY3556050 for the treatment of diabetic peripheral neuropathic pain. This trial is part of the chronic pain master protocol (H0P-MC-CPMP) 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 \<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 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.
* 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.
* 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.
* Have a history within 2 years prior to screening or current evidence of syncope, presyncope, uncontrolled vertigo, or postural dizziness, judged to be clinically significant by the investigator.
* Have clinically significant active thyroid disease, including Hashimoto's thyroiditis.
* Are taking metformin therapy. Metformin Exception Limited dosages of metformin are allowed in this study. Additional exclusion criteria for participants taking metformin.

  * Have a history or presence of lactic acidosis.
  * Have a history or presence of severe hepatic disease including cirrhosis.
  * Have uncontrolled or unstable congestive heart failure.
  * Are taking carbonic anhydrase inhibitors if also taking metformin.
  * Have had a change in metformin therapy in the last 12 weeks.
  * Have not maintained a stable dose of glucose-lowering agents other than metformin before randomization.
  * Are pregnant or breastfeeding.
  * Have fibromyalgia.

Primary outcomes:
measure: Change From Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)
timeFrame: Baseline, Week 8
Secondary outcomes:
measure: Change From Baseline in the Brief Pain Inventory-Short Form Modified (BPI-SFM) Total Pain Interference Score
timeFrame: Baseline, Week 8
measure: Change From Baseline for Overall Improvement as Measured by Patient's Global Impression of Change
timeFrame: Baseline, Week 8
measure: Change From Baseline for Worst Pain Intensity as Measured by NRS
timeFrame: Baseline, Week 8
measure: Change From Baseline on the Visual Analog Scale (VAS) for Pain
timeFrame: Baseline, Week 8
measure: Change From Baseline on the Sleep Scale From the Medical Outcomes Study (MOS Sleep Scale) - Average Hours of Sleep
timeFrame: Baseline, Week 8
measure: Total Amount of Rescue Medication Use as Measured by Average Daily Dosage
timeFrame: Week 8
measure: Change From Baseline on the EuroQuality of Life Five Dimensions (5D) Five Level (5L) Questionnaire (EQ-5D-5L) Health State Index (United States Algorithm)
timeFrame: Baseline, Week 8
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Synexus- Chandler
state: Arizona
city: Glendale
country: United States
facility: Synexus Clinical Research - Glendale
state: Arizona
city: Tempe
country: United States
facility: Alliance for Multispecialty Research - Clinical Research Consortium
state: Arizona
city: Riverside
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Hamden
country: United States
facility: CMR of Greater New Haven
state: Connecticut
city: Aventura
country: United States
facility: VIN-Julie Schwartzbard
state: Florida
city: Coral Gables
country: United States
facility: Clinical Research of South Florida
state: Florida
city: Miami
country: United States
facility: Suncoast Research Group
state: Florida
city: Miami
country: United States
facility: University of Miami Don Suffer Clinical Research Building
state: Florida
city: Miami
country: United States
facility: New Horizon Research Center
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Orlando
country: United States
facility: Synexus Clinical Research US, Inc - Orlando
state: Florida
city: Pinellas Park
country: United States
facility: Synexus Clinical Research US, Inc.
state: Florida
city: Plantation
country: United States
facility: Gold Coast Research
state: Florida
city: The Villages
country: United States
facility: Synexus Clinical Research US, Inc - Orlando
state: Florida
city: Idaho Falls
country: United States
facility: Rocky Mountain Clinical Research
state: Idaho
city: Chicago
country: United States
facility: Synexus Clinical Research US, Inc.
state: Illinois
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Skokie
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
city: Methuen
country: United States
facility: ActivMed Practices and Research
state: Massachusetts
city: Waltham
country: United States
facility: MedVadis Research Corporation
state: Massachusetts
city: Bay City
country: United States
facility: Great Lakes Research Group, Inc.
state: Michigan
city: Saint Peters
country: United States
facility: StudyMetrix Research
state: Missouri
city: Springfield
country: United States
facility: Clinvest Research LLC
state: Missouri
city: Cincinnati
country: United States
facility: Synexus - Cincinnati
state: Ohio
city: Dayton
country: United States
facility: META Medical Research Institute
state: Ohio
city: Duncansville
country: United States
facility: Altoona Center For Clinical Research
state: Pennsylvania
city: Austin
country: United States
facility: FutureSearch Trials
state: Texas
city: Dallas
country: United States
facility: Cedar Health Research
state: Texas
city: San Antonio
country: United States
facility: Synexus - US
state: Texas
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
city: Ponce
country: Puerto Rico
facility: Ponce Medical School Foundation Inc.
city: San Juan
country: Puerto Rico
facility: Latin Clinical Trial Center
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: