A Phase 2, Randomized, Double-Blind, Placebo Controlled, Dose-Ranging Study to Evaluate LY3556050 in Adult Participants With Diabetic Peripheral Neuropathic Pain
A Phase 2, Randomized, Double-Blind, Placebo Controlled, Dose-Ranging Study to Evaluate LY3556050 in Adult Participants With Diabetic Peripheral Neuropathic Pain
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.
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:
Chandler, Arizona 85225, United States
European Union, Rychnov Nad Kněžnou 516 01, Czechia
Suita-shi, Osaka 565-0853, Japan
Sokashi, Saitama 340-0015, Japan
Ootaku, Tokyo 143-0015, Japan
Shinjuku-ku, Tokyo 160-0008, Japan
Krakow, Lesser Poland Voivodeship 31-261, Poland
Wroclaw, Lower Silesian Voivodeship 51-162, Poland
Wyszków, Masovian Voivodeship 07-200, Poland
Biaystok, Podlaskie Voivodeship 15-351, Poland
Ruda Śląska, Silesian Voivodeship 41-709, Poland
Lodz, Łódź Voivodeship 90-338, Poland
Sosa-gu, Kyǒnggi-do 14754, South Korea