Northwest Clinical Research Center | Bellevue, WA
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
The main purpose of this study is to determine the safety and efficacy of LY3556050 versus placebo in participants with diabetic peripheral neuropathic pain (DPNP). The study will lasts approximately 24 weeks, across 3 study periods.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Have a history and current diagnosis of Type 1 Diabetes (T1D) or Type 2 Diabetes (T2D) diagnosed for at least 6 months prior to screening.
Have a stable glycemic control on stable diabetes treatment regimen for at least 90 days prior to day 1 with a hemoglobin A1c (HbA1c) ≤10 for T1D and HbA1c ≤11 for participants with T2D at time of screening.
Have a history of daily peripheral neuropathic pain for at least 12 weeks based on participant report or medical history.
Have a visual analog scale (VAS) pain value ≥40 and <95 during screening.
Have presence of diabetic peripheral neuropathy of symmetrical nature and in lower extremities for ≥6 months and diagnosed by a score of Part B ≥3 on Michigan Neuropathy Screening Instrument
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, except allowed concomitant pain medication permitted per protocol, for the duration of the study
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
410 participants in 4 patient groups, including a placebo group
Loading...
Central trial contact
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal