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

NCT06074562 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: 18509J2P-MC-LXBD2023-506127-29-00
• Study Type: interventional
• Target: 404
• Locations: 5 countries
• Sites: 70

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.

Conditions

Diabetic Peripheral Neuropathy

Outcome Measures

Primary Outcomes (2)

• Mean Change From Baseline in Average Pain Intensity (API) as Measured by Weekly Average of Numeric Rating Scale (NRS) - Bayesian Model Averaging (BMA) Dose-response Model

  * The NRS was a single-item numeric scale used to describe pain severity. Participants were asked to rate their average pain over the past 24 hours, on a scale of 0 to 10: 0 = no pain, and 10 = pain as bad as you can imagine; a higher score indicates worse outcome (greater pain severity). * The mixed-model repeated measures (MMRM) model included the fixed, centered, categorical effects of region, baseline NRS average pain score, as well as concurrent use of allowed concomitant medications (yes vs. no based on interactive web response system \[IWRS\]), and visit. The adjusted dose response value from the MMRM was used for fitting a Bayesian model averaging (BMA) dose-response model. * Posterior mean change from baseline, 95 percent (%) credible interval was derived using Bayesian mixed model repeated measures. Data presented were posterior mean with 95% credible interval.

  Baseline, Week 12

• Mean Change From Baseline in Average Pain Intensity (API) as Measured by Weekly Average of Numeric Rating Scale (NRS) - Frequentist Repeated Measures (FRM) Analysis

  * The NRS was a single-item numeric scale used to describe pain severity. Participants were asked to rate their average pain over the past 24 hours, on a scale of 0 to 10: 0 = no pain, and 10 = pain as bad as you can imagine; a higher score indicates worse outcome (greater pain severity). * The Least Squares (LS) Mean was calculated using a frequentist repeated measures (FRM) analysis, where Change = treatment, time interval, treatment \* time interval, region, average baseline pain severity category (mild or moderate versus \[vs.\] severe), concurrent use of allowed concomitant medication as entered in IWRS (yes versus no).

  Baseline, Week 12

Secondary Outcomes (12)

• Mean Change From Baseline in Worst Pain Intensity (WPI) as Measured by Weekly Average of Numeric Rating Scale (NRS)

  Baseline, Week 12

• Mean Change From Baseline in Patient-Reported Outcomes Measurement Information System Pain Interference Short Form 8a (PROMIS PI SF8a)

  Baseline, Week 12

• Mean Change From Baseline in Pain Interference With Sleep

  Baseline, Week 12

• Mean Change From Baseline in Patient-Reported Outcomes Measurement Information System Physical Functioning Short Form 10a (PROMIS PF SF10a)

  Baseline, Week 12

• Mean Change From Baseline in Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS SD SF8b)

  Baseline, Week 12

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Participants received a matching dose of placebo administered orally twice daily (BID) over a period of 12 weeks.

Drug: Placebo

Mazisotine 50 mg

EXPERIMENTAL

Participants received mazisotine 50 milligrams (mg) administered orally BID over a period of 12 weeks.

Drug: Mazisotine

Mazisotine 200 mg

EXPERIMENTAL

Participants received mazisotine BID orally, starting at 50 mg and titrated weekly, reaching 100 mg BID by Week 2 and a target maintenance dose of 200 mg BID by Week 3, which was then maintained up to Week 12.

Drug: Mazisotine

Mazisotine 400 mg

EXPERIMENTAL

Participants received mazisotine BID orally, starting at 50 mg and titrated weekly, reaching 100 mg BID by Week 2, 200 mg BID by Week 3, and 300 mg BID by Week 4, until reaching a target maintenance dose of 400 mg BID by Week 5, which was then maintained up to Week 12.

Drug: Mazisotine

Interventions

Placebo DRUG

Administered orally.

Placebo

Mazisotine DRUG

Administered orally.

Also known as: LY3556050

Mazisotine 200 mg; Mazisotine 400 mg; Mazisotine 50 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (70)

The Institute for Liver Health II dba Arizona Clinical Trials - Mesa

Chandler, Arizona, 85225, United States

Location

Headlands Research - Scottsdale

Scottsdale, Arizona, 85260, United States

Location

Orange Grove Family Practice

Tucson, Arizona, 85741, United States

Location

Preferred Research Partners

Little Rock, Arkansas, 72211, United States

Location

Hope Clinical Research, Inc.

Canoga Park, California, 91303, United States

Location

Valley Clinical Trials, Inc.

Northridge, California, 91325, United States

Location

Northern California Research - Sacramento

Sacramento, California, 95821, United States

Location

CMR of Greater New Haven, LLC

Hamden, Connecticut, 06517, United States

Location

Suncoast Research Group

Miami, Florida, 33135, United States

Location

New Horizon Research Center

Miami, Florida, 33165, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Alliance for Multispecialty Research, LLC

Wichita, Kansas, 67205, United States

Location

Alliance for Multispecialty Research, LLC

Lexington, Kentucky, 40509, United States

Location

Care Access - Lake Charles

Lake Charles, Louisiana, 70601, United States

Location

MedVadis Research Corporation

Waltham, Massachusetts, 02451, United States

Location

SKY Integrative Medical Center/SKYCRNG

Ridgeland, Mississippi, 39157, United States

Location

StudyMetrix Research

City of Saint Peters, Missouri, 63303, United States

Location

Alliance for Multispecialty Research, LLC

Kansas City, Missouri, 64114, United States

Location

Clinvest Research LLC

Springfield, Missouri, 65807, United States

Location

Las Vegas Medical Research

Las Vegas, Nevada, 89128, United States

Location

UniMed Center

East Brunswick, New Jersey, 08816, United States

Location

North Suffolk Neurology

Port Jefferson Station, New York, 11776, United States

Location

Lucas Research - Hickory

Hickory, North Carolina, 28601, United States

Location

Lucas Research, Inc

Morehead City, North Carolina, 28557, United States

Location

Velocity Clinical Research, Medford

Medford, Oregon, 97504, United States

Location

Tristar Clinical Investigations

Philadelphia, Pennsylvania, 19114, United States

Location

Suburban Research Associates

West Chester, Pennsylvania, 19380, United States

Location

New Phase Research and Development

Knoxville, Tennessee, 37909, United States

Location

FutureSearch Trials of Neurology

Austin, Texas, 78731, United States

Location

Juno Research

Houston, Texas, 77040, United States

Location

Consano Clinical Research, LLC

Shavano Park, Texas, 78231, United States

Location

Velocity Clinical Research, Salt Lake City

West Jordan, Utah, 84088, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

Location

Rainier Clinical Research Center

Renton, Washington, 98057, United States

Location

EDUMED - Broumov

Broumov, Hradec Králové Region, 550 01, Czechia

Location

Diabet2 s.r.o., diabetologicka a interni ambulance

Prague, Praha 1, 11000, Czechia

Location

Neurologická Ambulance - Forbeli

Prague, Praha 6, 160 00, Czechia

Location

DiaVize s.r.o.

Prague, Praha, Hlavní Mešto, 140 00, Czechia

Location

FLEDIP - Na dlouhem lanu

Prague, Praha, Hlavní Mešto, 160 00, Czechia

Location

Vestra Clinics

European Union, Rychnov Nad Kněžnou, 516 01, Czechia

Location

Agentura Science Pro

Olomouc, 779 00, Czechia

Location

Matsuyama Shimin Hospital

Matsuyama, Ehime, 790-0067, Japan

Location

Kikuchi Naika Clinic

Maebashi, Gunma, 370-3573, Japan

Location

Kure Medical Center

Kure, Hiroshima, 737-0023, Japan

Location

Japanese Red Cross Asahikawa Hospital

Asahikawa, Hokkaido, 070-8530, Japan

Location

Yokohama Minoru Clinic

Yokohama, Kanagawa, 232-0064, Japan

Location

Medical Corporation Heishinkai OCROM Clinic

Suita-shi, Osaka, 565-0853, Japan

Location

Sugiura Internal Medicine Clinic

Sokashi, Saitama, 340-0015, Japan

Location

Suruga Clinic

Shizuoka, Shizuoka, 424-0855, Japan

Location

Medical Corporation Sato Medical clinic

Ootaku, Tokyo, 143-0015, Japan

Location

Heishinkai Medical Group ToCROM Clinic

Shinjuku-ku, Tokyo, 160-0008, Japan

Location

Kunisaki Makoto Clinic

Fukuoka, 819-0168, Japan

Location

Minamiosaka Hospital

Osaka, 559-0012, Japan

Location

Plumeria DM Clinic

Shizuoka, 422-8006, Japan

Location

Nzoz Neuro-Kard Ilkowski i Partnerzy SPL

Poznan, Greater Poland Voivodeship, 61-853, Poland

Location

MICS Centrum Medyczne Torun

Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland

Location

Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET

Krakow, Lesser Poland Voivodeship, 31-261, Poland

Location

Centrum Badań Klinicznych Piotr Napora lekarze sp.p.

Wroclaw, Lower Silesian Voivodeship, 51-162, Poland

Location

MICS Centrum Medyczne Warszawa

Warsaw, Masovian Voivodeship, 00-874, Poland

Location

Samodzielny Publiczny Zespol Opieki Zdrowotnej w Wyszkow

Wyszków, Masovian Voivodeship, 07-200, Poland

Location

Zdrowie Osteo-Medic

Biaystok, Podlaskie Voivodeship, 15-351, Poland

Location

Centrum Medyczne Pratia Katowice

Katowice, Silesian Voivodeship, 40-081, Poland

Location

Pro Familia Altera

Katowice, Silesian Voivodeship, 40-648, Poland

Location

NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki

Ruda Śląska, Silesian Voivodeship, 41-709, Poland

Location

Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna

Lodz, Łódź Voivodeship, 90-338, Poland

Location

Sejong General Hospital

Sosa-gu, Kyǒnggi-do, 14754, South Korea

Location

Nowon Eulji Medical Center, Eulji University

Seoul, Seoul-teukbyeolsi [Seoul], 01830, South Korea

Location

Konkuk University Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], 05030, South Korea

Location

Samsung Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], 06351, South Korea

Location

Eulji University Hospital

Daejeon, Taejǒn-Kwangyǒkshi, 01830, South Korea

Location

Related Links

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

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 10, 2023
• Study Start: October 5, 2023
• Primary Completion: June 11, 2025
• Study Completion: June 11, 2025
• Last Updated: July 30, 2026
• Results First Posted: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

JP (13); PL (11); KR (5); US (34); CZ (7)