Clinical trial NCT06074562: A Study of LY3556050 in Adult Participants With Diabetic Peripheral Neuropathic Pain
Official title: A Phase 2, Randomized, Double-Blind, Placebo Controlled, Dose-Ranging Study to Evaluate LY3556050 in Adult Participants With Diabetic Peripheral Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Diabetic Peripheral Neuropathy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-10-10
Enrollment: 410
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: 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.


Eligibility criteria: 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

  * Have a body mass index ≤45 kilogram/square meter (kg/m²) (inclusive).
  * Are men, or women able to abide by reproductive and contraceptive requirements.

Exclusion Criteria:

* History of other potentially causative and/or confounding sources of pain that may impair self-assessment of pain due to DPNP.
* 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 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 in the judgement 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 positive HIV test result at screening.
* Have a surgery planned during the study for any reason.
* Have a substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (5th edition; DSM-5; American Psychiatric Association)

Primary outcomes:
measure: Mean Change from Baseline for Average Pain Intensity Numeric Rating Scale (API-NRS)
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Mean Change from Baseline for Worst Pain Intensity Numeric Rating Scale (WPI-NRS)
timeFrame: Baseline, Week 12
measure: Mean Change from Baseline for Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form (SF)8a
timeFrame: Baseline, Week 12
measure: Mean Change from Baseline for Pain Interference with Sleep
timeFrame: Baseline, Week 12
measure: Mean Change from Baseline for PROMIS Physical Functioning Short Form (SF)10a
timeFrame: Baseline, Week 12
measure: Mean Change from Baseline for PROMIS Sleep Disturbance (SD)8b
timeFrame: Baseline, Week 12
measure: Mean Change from Baseline for Patient's Global Impression of Illness (PGI) Severity as Measured by PGI-Severity
timeFrame: Baseline, Week 12
measure: Mean Change from Baseline for Patient's Global Impression of Illness Status as Measured by PGI-Status
timeFrame: Baseline, Week 12
measure: Mean Change from Baseline for Patient's Global Impression of Change as Measured by PGI-Change
timeFrame: Baseline, Week 12
measure: Mean Change from Baseline for Neuropathy Total Symptom Score-6 (NTSS-6)
timeFrame: Baseline, Week 12
measure: Summary of Frequency, Timing and Amount of Rescue Medication Used During the Treatment Period
timeFrame: Baseline to Week 12
measure: Pharmacokinetics (PK): Plasma Concentration of LY3556050
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: Chandler
country: United States
facility: The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
state: Arizona
city: Scottsdale
country: United States
facility: Headlands Research - Scottsdale
state: Arizona
city: Tucson
country: United States
facility: Orange Grove Family Practice
state: Arizona
city: Little Rock
country: United States
facility: Preferred Research Partners
state: Arkansas
city: Canoga Park
country: United States
facility: Hope Clinical Research, Inc.
state: California
city: Northridge
country: United States
facility: Valley Clinical Trials, Inc.
state: California
city: Sacramento
country: United States
facility: Northern California Research - Sacramento
state: California
city: Hamden
country: United States
facility: CMR of Greater New Haven, LLC
state: Connecticut
city: Miami
country: United States
facility: Suncoast Research Group
state: Florida
city: Miami
country: United States
facility: New Horizon Research Center
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Wichita
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Kansas
city: Lexington
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Kentucky
city: Lake Charles
country: United States
facility: Care Access - Lake Charles
state: Louisiana
city: Waltham
country: United States
facility: MedVadis Research Corporation
state: Massachusetts
city: Ridgeland
country: United States
facility: SKY Integrative Medical Center/SKYCRNG
state: Mississippi
city: Kansas City
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Missouri
city: Saint Peters
country: United States
facility: StudyMetrix Research
state: Missouri
city: Springfield
country: United States
facility: Clinvest Research LLC
state: Missouri
city: Las Vegas
country: United States
facility: Las Vegas Medical Research
state: Nevada
city: East Brunswick
country: United States
facility: UniMed Center
state: New Jersey
city: Port Jefferson Station
country: United States
facility: North Suffolk Neurology
state: New York
city: Hickory
country: United States
facility: Lucas Research - Hickory
state: North Carolina
city: Morehead City
country: United States
facility: Lucas Research, Inc
state: North Carolina
city: Medford
country: United States
facility: Velocity Clinical Research, Medford
state: Oregon
city: Philadelphia
country: United States
facility: Tristar Clinical Investigations
state: Pennsylvania
city: West Chester
country: United States
facility: Suburban Research Associates
state: Pennsylvania
city: Knoxville
country: United States
facility: New Phase Research and Development
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Trials of Neurology
state: Texas
city: Houston
country: United States
facility: Juno Research
state: Texas
city: Shavano Park
country: United States
facility: Consano Clinical Research, LLC
state: Texas
city: West Jordan
country: United States
facility: Velocity Clinical Research, Salt Lake City
state: Utah
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: Broumov
country: Czechia
facility: EDUMED - Broumov
state: Královéhradecký Kraj
city: Praha
country: Czechia
facility: Diabet2 s.r.o., diabetologicka a interni ambulance
state: Praha 1
city: Praha
country: Czechia
facility: Neurologická Ambulance - Forbeli
state: Praha 6
city: Prague
country: Czechia
facility: FLEDIP - Na dlouhem lanu
state: Praha, Hlavní Mešto
city: Praha 4
country: Czechia
facility: DiaVize s.r.o.
state: Praha, Hlavní Mešto
city: European Union
country: Czechia
facility: Vestra Clinics
state: Rychnov Nad Kněžnou
city: Olomouc
country: Czechia
facility: Agentura Science Pro
city: Matsuyama
country: Japan
facility: Matsuyama Shimin Hospital
state: Ehime
city: Maebashi
country: Japan
facility: Kikuchi Naika Clinic
state: Gunma
city: Kure
country: Japan
facility: Kure Medical Center
state: Hiroshima
city: Asahikawa
country: Japan
facility: Japanese Red Cross Asahikawa Hospital
state: Hokkaido
city: Yokohama
country: Japan
facility: Yokohama Minoru Clinic
state: Kanagawa
city: Suita-shi
country: Japan
facility: Medical Corporation Heishinkai OCROM Clinic
state: Osaka
city: Sokashi
country: Japan
facility: Sugiura Internal Medicine Clinic
state: Saitama
city: Shizuoka-city
country: Japan
facility: Suruga Clinic
state: Shizuoka
city: Ootaku
country: Japan
facility: Medical Corporation Sato Medical clinic
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Heishinkai Medical Group ToCROM Clinic
state: Tokyo
city: Fukuoka
country: Japan
facility: Kunisaki Makoto Clinic
city: Osaka
country: Japan
facility: Minamiosaka Hospital
city: Shizuoka
country: Japan
facility: Plumeria DM Clinic
city: Sosa-gu
country: Korea, Republic of
facility: Sejong General Hospital
state: Kyǒnggi-do
city: Seoul
country: Korea, Republic of
facility: Nowon Eulji Medical Center, Eulji University
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Seoul-teukbyeolsi [Seoul]
city: Daejeon
country: Korea, Republic of
facility: Eulji University Hospital
state: Taejǒn-Kwangyǒkshi
city: Wroclaw
country: Poland
facility: Centrum Badań Klinicznych Piotr Napora lekarze sp.p.
state: Dolnośląskie
city: Torun
country: Poland
facility: MICS Centrum Medyczne Torun
state: Kujawsko-pomorskie
city: Warszawa
country: Poland
facility: MICS Centrum Medyczne Warszawa
state: Mazowieckie
city: Wyszkow
country: Poland
facility: Samodzielny Publiczny Zespol Opieki Zdrowotnej w Wyszkow
state: Mazowieckie
city: Krakow
country: Poland
facility: Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET
state: Małopolskie
city: Biaystok
country: Poland
facility: Zdrowie Osteo-Medic
state: Podlaskie
city: Poznan
country: Poland
facility: Nzoz Neuro-Kard Ilkowski i Partnerzy SPL
state: Wielkopolskie
city: Lodz
country: Poland
facility: Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
state: Łódzkie
city: Katowice
country: Poland
facility: Centrum Medyczne Pratia Katowice
state: Śląskie
city: Katowice
country: Poland
facility: Pro Familia Altera
state: Śląskie
city: Ruda Slaska
country: Poland
facility: NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki
state: Śląskie
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: