Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
410
Countries
2
Sites
18
Diabetic Peripheral Neuropathy
To demonstrate that at least one dose of LY3556050 is superior to placebo in pain intensity.
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 5 Mar 2024 → 12 Jun 2025
- Decision date (initial)
- 2024-02-21
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-506127-29-00
- WHO UTN
- U1111-1297-4702
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Pharmacokinetic, Efficacy, Dose response
To demonstrate that at least one dose of LY3556050 is superior to placebo in pain intensity.
Conditions and MedDRA coding
Diabetic Peripheral Neuropathy
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Are at least 18 years or older old at time of ICF signature.
- Have Type 1 Diabetes or Type 2 Diabetes 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 of oral hypoglycemics medication.
- Are willing to discontinue all medications taken for chronic pain conditions.
- Are willing to abide by reproductive and contraceptive requirements.
Exclusion criteria 5
- Have history of painful neuropathies other than DPNP
- Have symptomatic peripheral vascular disease.
- Have uncontrolled diabetes.
- Have a surgery planned.
- Have had cancer in past 2 years.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Mean Change from Baseline for Average Pain Intensity Numeric Rating Scale (API-NRS)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD10779218 · Product
- Active substance
- LY3556050
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD10779499 · Product
- Active substance
- LY3556050
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Eli Lilly & Co.
- Sponsor organisation
- Eli Lilly & Co.
- Address
- 1 Lilly Corporate Center
- City
- Indianapolis
- Postcode
- 46285-0001
- Country
- United States
Scientific contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Public contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Third parties 11
| Organisation | City, country | Duties |
|---|---|---|
| Iqvia Rds Inc. ORG-100043858
|
Durham, United States | Laboratory analysis |
| Syneos Health Inc. ORG-100008382
|
Morrisville, United States | Code 11 |
| Tier1 Performance ORL-000002650
|
Covington, United States | Other |
| Q2 Solutions Singapore ORL-000002648
|
Singapore | Laboratory analysis |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Data management |
| Empatica Inc. ORG-100044397
|
Cambridge, United States | Data management |
| Quintiles Laboratories Europe ORG-100017355
|
Livingston, United Kingdom | Laboratory analysis |
| IQVIA RDS (India) Private Limited ORG-100047036
|
Mumbai, India | On site monitoring, Other |
| Q Squared Solutions Holdings LLC ORG-100043288
|
Valencia, United States | Laboratory analysis |
| Q2 Solutions ORL-000002649
|
Tokyo, Japan | Laboratory analysis |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
Locations
2 EU/EEA countries · 18 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ended | 30 | 6 |
| Poland | Ended | 116 | 12 |
| Rest of world
Japan, United States, Korea, Republic of
|
— | 264 | — |
Investigational sites
Vestra Clinics s.r.o.
diabetogie - private, Jiraskova 1389, 516 01, Rychnov Nad Kneznou
Fledip s.r.o.
diabetogie - private, Tetinska 331/2, 150 00, Prague 5
Agentura Science Pro spol. s r.o.
diabetogie - private, Holubova 232/26, 779 00, Svaty Kopecek
Forbeli s.r.o.
neuropsychiatrie, Za Valem 1497/6 Kunratice, 148 00, Prague
Diabet2 s.r.o.
diabetogie - private, Lucni 1611, 263 01, Dobris
Edumed s.r.o.
diabetogie - private, Smetanova 91, 550 01, Broumov
Medicover Integrated Clinical Services Sp. z o.o.
MICS Centrum Medyczne Warszawa, Ul Wronia 53 Lok B 10, 00-874, Warsaw
Centrum Badan Klinicznych Piotr Napora Lekarze sp.p.
Centrum Badań Klinicznych Piotr Napora lekarze sp.p., Ul. Ul. Jana Dlugosza 4, 51-162, Wroclaw
Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne Diab-Endo-Met Sp. z o.o.
Diabetology, Ul. Rusznikarska 17, 31-261, Cracow
Osteo Medic s.c. Artur Racewicz Jerzy Supronik
Diabetology Department, Ul. Wiejska 81, 15-351, Bialystok
Pratia S.A.
Centrum Medyczne Pratia Katowice, Ul. Dabrowki 13, 40-081, Katowice
Pro Familia Altera Sp. z o.o.
Pro Familia Altera Poradnia Wielospecjalistyczna, Ul. Stanislawa Letowskiego 16 A, 40-648, Katowice
Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W Katowicach
Samodzielny Publiczny Szpital Kliniczny nr 1 SUM, Ul. 3 Maja 13/15, 41-800, Zabrze
Samodzielny Publiczny Zespol Zakladow Opieki Zdrowotnej W Wyszkowie
Samodzielny Publiczny Zespol Opieki Zdrowotnej w Wyszkow, Ul. Komisji Edukacji Narodowej 1, 07-200, Wyszkow
Medicover Integrated Clinical Services Sp. z o.o.
MICS Centrum Medyczne Torun, Ul. Stefana Batorego 18/22, 87-100, Torun
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna, Ul. Przedzalniana 66, 90-338, Lodz
Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Specjalistyczna A Wittek H Rudzki Sp. j.
NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki, Ul. Piotra Niedurnego 50 D, 41-709, Ruda Slaska
Ilkowski I Partnerzy sp.p. Lekarzy
Nzoz Neuro-Kard Ilkowski i Partnerzy SPL, Ul. Wierzbowa 2/2, 61-853, Poznan
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Czechia | 2024-03-05 | 2025-06-11 | 2024-03-06 | 2025-01-17 | |
| Poland | 2024-03-05 | 2025-06-04 | 2024-03-07 | 2025-01-17 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 73 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-506127-29-00_Redacted | e |
| Protocol (for publication) | D4_Patient facing documents Copyright Statement | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and ICF procedure | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment Material Database_and_Patient_Messaging | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material Digital_Ads_Master | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material Doctor Referral | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material Landing_Page | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material Poster | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material Screener_Master | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material Search_Ads | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material Trial Awareness Brochure | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Database_and_Patient_Messaging_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Digital_Ads_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Landing_Page_Copy_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Letter-Doctor-Referral_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_List of planned sites | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_List of planned sites_Redacted | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Screener_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Search_Ads_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_WS_Script_Master | 1 |
| Recruitment arrangements (for publication) | K4_Recruitment arrangements_Informed consent and patient recruitment procedure | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_Main_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_ICF_Main_TC_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_ICF_Pregnant Partner | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_prescreening addendum | 3 |
| Subject information and informed consent form (for publication) | L1_ICF_prescreening addendum_TC | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DPA | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Prescreening_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Prescreening_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Reimbursement_redacted | 1 |
| Subject information and informed consent form (for publication) | L2_EmbracePlusSmartwatch_CS_Smartphone | 1 |
| Subject information and informed consent form (for publication) | L2_Other information material_EC_packet_w_Data_Privacy_as_applied_to_GP | 9 |
| Subject information and informed consent form (for publication) | L2_Other information material_Greenphire ClinCard Msg Templates-ROW | 6 |
| Subject information and informed consent form (for publication) | L2_Other information material_Greenphire_ClinCard_Card_Carrier_EU | 1 |
| Subject information and informed consent form (for publication) | L2_Other information material_Greenphire_ClinCard_Cardholder_FAQ_EU | 3 |
| Subject information and informed consent form (for publication) | L2_Other information material_Greenphire_Fee_Schedule | 4 |
| Subject information and informed consent form (for publication) | L2_Other information material_Template-Greenphire EU Generic ClinCard | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Ancillary Supply List | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Emergency Card LXBD - Poland | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Acetaminophen_Paracetamol Dosing Tracker Tool | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Acetaminophen_Paracetamol Dosing Tracker Tool_Final_CZ | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_CT_Thank-You-Dropout_Master | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_CT_Thank-You-End-Of-Study_Master | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_CT_Thank-You-Participation_Master | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_CT_thank-you-screening_master | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_EmbracePlusSmartwatch_A5 | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_EmbracePlusSmartwatch_Smartphone | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Knowledge Assessment | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Poster_Master | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study-Guide_Master_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study-Guide_Master_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Subject Directions for Use | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Subject Directions for Use_Redacted | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Subject Education Video Script | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Thank-You-Dropout_Master | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Thank-You-End-Of-Study_Master | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Thank-You-Participation_Master | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Thank-You-Screening_Master | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Trial-Awareness-Brochure_Master | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Visit-Card_Master | 1 |
| Subject information and informed consent form (for publication) | L2_Patient Documents Not submitted_PL | 1 |
| Subject information and informed consent form (for publication) | L2_Patient Information Card CZ | 2 |
| Subject information and informed consent form (for publication) | L2_Subject Directions for Use DFU of IP_CZ | 1.0 |
| Subject information and informed consent form (for publication) | L3_EC_packet_w_Data_Laws_as_applied_to_GP | 7 |
| Subject information and informed consent form (for publication) | L5_Info Re insurance Conditions for Patient | 1 |
| Subject information and informed consent form (for publication) | Patient Knowledge Assessment_WS_Paper | 1 |
| Subject information and informed consent form (for publication) | Subject Education Video Script_WS_Paper | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_CZ_2023-506127-29-00_Redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ENG 2023-506127-29-00_Redacted | e |
| Synopsis of the protocol (for publication) | D1_protocol synopsis_PL_2023-506127-29-00_LXBD_Redacted | e |
Application history
11 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-13 | Czechia | Acceptable 2024-02-16
|
2024-02-19 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-28 | Czechia | Acceptable 2024-05-13
|
2024-05-20 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-07-05 | Czechia | Acceptable 2024-09-06
|
2024-09-09 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-09-18 | Czechia | Acceptable | 2024-11-01 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-09-19 | Acceptable | 2024-10-28 | |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-03-19 | Acceptable | 2025-03-19 | |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-03-26 | Acceptable | 2025-03-26 | |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-04-24 | Acceptable | 2025-04-24 | |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-05-23 | Czechia | Acceptable | 2025-05-23 |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-07-17 | Czechia | Acceptable | 2025-07-17 |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2025-12-11 | Czechia | Acceptable | 2025-12-11 |