A Study of LY3556050 in Adult Participants With Diabetic Peripheral Neuropathic Pain

Diabetic Peripheral Neuropathy Clinical Trial

Official title:

A Phase 2, Randomized, Double-Blind, Placebo Controlled, Dose-Ranging Study to Evaluate LY3556050 in Adult Participants With Diabetic Peripheral Neuropathic Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06074562
• Other study ID #: 18509
• Secondary ID: J2P-MC-LXBD2023-
• Status: Recruiting
• Phase: Phase 2
• Start date: October 5, 2023
• Est. completion date: January 31, 2025

Study information

• Verified date: June 15, 2024
• Source: Eli Lilly and Company
• Contact: There may be multiple sites in this clinical trial. 1-877-CTLILL
• Phone: 1-317-615-4559
• Email: ClinicalTrials.gov[@]lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 410
• Est. completion date: January 31, 2025
• Est. primary completion date: January 17, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 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)

Related Conditions & MeSH terms

• Diabetic Peripheral Neuropathy
• Neuralgia
• Peripheral Nervous System Diseases

Intervention

Drug:
• LY3556050
Administered orally.
• Placebo
Administered orally.

Locations

Country	Name	City	State
Czechia	EDUMED - Broumov	Broumov	Královéhradecký Kraj
Czechia	Vestra Clinics	European Union	Rychnov Nad Knežnou
Czechia	Agentura Science Pro	Olomouc
Czechia	FLEDIP s.r.o.	Prague	Praha, Hlavní Mešto
Czechia	Diabet2 s.r.o., diabetologicka a interni ambulance	Praha	Praha 1
Czechia	Neurologická Ambulance - Forbeli	Praha	Praha 6
Czechia	DiaVize s.r.o.	Praha 4	Praha, Hlavní Mešto
Japan	Japanese Red Cross Asahikawa Hospital	Asahikawa	Hokkaido
Japan	Kunisaki Makoto Clinic	Fukuoka
Japan	Kure Medical Center	Kure	Hiroshima
Japan	Kikuchi Naika Clinic	Maebashi	Gunma
Japan	Matsuyama Shimin Hospital	Matsuyama	Ehime
Japan	Medical Corporation Sato Medical clinic	Ootaku	Tokyo
Japan	Minamiosaka Hospital	Osaka
Japan	Heishinkai Medical Group ToCROM Clinic	Shinjuku-ku	Tokyo
Japan	Plumeria DM Clinic	Shizuoka
Japan	Suruga Clinic	Shizuoka-city	Shizuoka
Japan	Sugiura Internal Medicine Clinic	Sokashi	Saitama
Japan	Medical Corporation Heishinkai OCROM Clinic	Suita-shi	Osaka
Japan	Yokohama Minoru Clinic	Yokohama	Kanagawa
Korea, Republic of	Eulji University Hospital	Daejeon	Taejon-Kwangyokshi
Korea, Republic of	Jeonbuk National University Hospital	Jeonju-si	Jeonrabugdo
Korea, Republic of	Konkuk University Medical Center	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Nowon Eulji Medical Center, Eulji University	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Samsung Medical Center	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Sejong General Hospital	Sosa-gu	Kyonggi-do
Poland	Osteo Medic sc A. Racewicz, J. Supronik	Biaystok	Podlaskie
Poland	Centrum Medyczne Pratia Katowice	Katowice	Slaskie
Poland	Pro Familia Altera	Katowice	Slaskie
Poland	NZOZ Diab-Endo-Met	Krakow	Malopolskie
Poland	Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna	Lodz	Lódzkie
Poland	Nzoz Neuro-Kard Ilkowski i Partnerzy SPL	Poznan	Wielkopolskie
Poland	NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki	Ruda Slaska	Slaskie
Poland	MICS Centrum Medyczne Torun	Torun	Kujawsko-pomorskie
Poland	Medycyna Kliniczna	Warszawa	Mazowieckie
Poland	Centrum Badan Klinicznych Piotr Napora lekarze sp.p.	Wroclaw	Dolnoslaskie
Poland	Samodzielny Publiczny Zespol Opieki Zdrowotnej w Wyszkow	Wyszkow	Mazowieckie
United States	FutureSearch Trials of Neurology	Austin	Texas
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Hope Clinical Research, Inc.	Canoga Park	California
United States	Northwestern University	Chicago	Illinois
United States	UniMed Center	East Brunswick	New Jersey
United States	CMR of Greater New Haven, LLC	Hamden	Connecticut
United States	Lucas Research, Inc.	Hickory	North Carolina
United States	Juno Research	Houston	Texas
United States	The Center for Pharmaceutical Research	Kansas City	Missouri
United States	New Phase Research and Development	Knoxville	Tennessee
United States	Care Access - Lake Charles	Lake Charles	Louisiana
United States	Las Vegas Medical Research	Las Vegas	Nevada
United States	Alliance for Multispecialty Research, LLC	Lexington	Kentucky
United States	Preferred Research Partners	Little Rock	Arkansas
United States	Velocity Clinical Research, Medford	Medford	Oregon
United States	The Institute for Liver Health dba Arizona Clinical Trials	Mesa	Arizona
United States	New Horizon Research Center	Miami	Florida
United States	Suncoast Research Group	Miami	Florida
United States	Lucas Research, Inc	Morehead City	North Carolina
United States	Valley Clinical Trials, Inc.	Northridge	California
United States	Tristar Clinical Investigations	Philadelphia	Pennsylvania
United States	North Suffolk Neurology	Port Jefferson Station	New York
United States	Rainier Clinical Research Center	Renton	Washington
United States	SKY Clinical Research Network Group-Quinn	Ridgeland	Mississippi
United States	Northern California Research - Sacramento	Sacramento	California
United States	StudyMetrix Research	Saint Peters	Missouri
United States	Headlands Research - Scottsdale	Scottsdale	Arizona
United States	Consano Clinical Research, LLC	Shavano Park	Texas
United States	Clinvest Research LLC	Springfield	Missouri
United States	Synexus Clinical Research US, Inc.//Orange Grove Family Practice	Tucson	Arizona
United States	MedVadis Research Corporation	Waltham	Massachusetts
United States	Suburban Research Associates	West Chester	Pennsylvania
United States	Velocity Clinical Research, Salt Lake City	West Jordan	Utah
United States	Alliance for Multispecialty Research, LLC	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Czechia,  Japan,  Korea, Republic of,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change from Baseline for Average Pain Intensity Numeric Rating Scale (API-NRS)		Baseline, Week 12
Secondary	Mean Change from Baseline for Worst Pain Intensity Numeric Rating Scale (WPI-NRS)		Baseline, Week 12
Secondary	Mean Change from Baseline for Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form (SF)8a		Baseline, Week 12
Secondary	Mean Change from Baseline for Pain Interference with Sleep		Baseline, Week 12
Secondary	Mean Change from Baseline for PROMIS Physical Functioning Short Form (SF)10a		Baseline, Week 12
Secondary	Mean Change from Baseline for PROMIS Sleep Disturbance (SD)8b		Baseline, Week 12
Secondary	Mean Change from Baseline for Patient's Global Impression of Illness (PGI) Severity as Measured by PGI-Severity		Baseline, Week 12
Secondary	Mean Change from Baseline for Patient's Global Impression of Illness Status as Measured by PGI-Status		Baseline, Week 12
Secondary	Mean Change from Baseline for Patient's Global Impression of Change as Measured by PGI-Change		Baseline, Week 12
Secondary	Mean Change from Baseline for Neuropathy Total Symptom Score-6 (NTSS-6)		Baseline, Week 12
Secondary	Summary of Frequency, Timing and Amount of Rescue Medication Used During the Treatment Period		Baseline to Week 12
Secondary	Pharmacokinetics (PK): Plasma Concentration of LY3556050		Baseline to Week 12

External Links

•   A Study of LY3556050 in Adult Participants With Diabetic Peripheral Neuropathic Pain