Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
450
Countries
2
Sites
13
Neuropathic Pain; Distal Sensory Polyneuropathy
To demonstrate that at least 1 dose of LY3848575 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
- 3 Jun 2025 → 15 Apr 2026
- Decision date (initial)
- 2025-05-23
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-513435-24-01
- WHO UTN
- U1111-1306-8618
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Pharmacokinetic, Safety, Others, Dose response, Pharmacodynamic
To demonstrate that at least 1 dose of LY3848575 is superior to placebo in pain intensity
Conditions and MedDRA coding
Neuropathic Pain; Distal Sensory Polyneuropathy
Regulatory references
- Plan to share IPD
- Yes
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-513435-24-00 | J4F-MC-CYAB: A Phase 2, Randomized, Double-Blind, Placebo Controlled, Dose-Finding Study Evaluating LY3848575 in Chronic Neuropathic Pain Associated With Distal Sensory Polyneuropathy | Eli Lilly & Co. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Are at least 18 years or older old at time of ICF signature.
- Have moderate to severe pain nerve pain at least 6 months prior to screening.
- Are willing to discontinue all medications taken for chronic pain conditions.
- Not be able to become pregnant.
Exclusion criteria 5
- Have other sources of pain that interfere with assessing nerve pain
- Have uncontrolled diabetes.
- Have a surgery planned.
- Have had chemotherapy for cancer in the last year that led to nerve pain
- Have history within 2 years of study entry of alcohol or substance use disorder
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Mean Change from Baseline in Average Pain Intensity Numeric Rating Scale (API-NRS)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD11453086 · Product
- Active substance
- LY3848575
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Month(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 13
| Organisation | City, country | Duties |
|---|---|---|
| PPD Global Central Labs ORG-100046496
|
Zaventem, Belgium | Laboratory analysis |
| Iqvia Biotech Limited ORG-100008726
|
Reading, United Kingdom | On site monitoring, Other |
| Syneos Health Inc. ORG-100008382
|
Morrisville, United States | Code 10, Code 11 |
| Medable Inc. ORG-100043083
|
Palo Alto, United States | Other |
| Brightech International LLC ORL-000002985
|
Somerset, New Jersey, United States | Code 10 |
| R Square Technology Inc. ORL-000009672
|
Chesterbrook, United States | Code 10 |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Data management |
| Clariness GmBH ORL-000009671
|
London, United Kingdom | Other |
| Veeva Systems Inc. ORG-100006053
|
Pleasanton, United States | E-data capture |
| Charles River Laboratories International Inc. ORG-100041066
|
Mattawan, United States | Laboratory analysis |
| IQVIA RDS (India) Private Limited ORG-100047036
|
Mumbai, India | Laboratory analysis |
| Empatica Inc. ORG-100044397
|
Cambridge, United States | Data management |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
Locations
2 EU/EEA countries · 13 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 16 | 5 |
| Poland | Ended | 51 | 8 |
| Rest of world
Mexico, United States, Japan, Korea, Republic of, Canada
|
— | 383 | — |
Investigational sites
Universitaetsklinikum Schleswig-Holstein AöR
N/A, Arnold-Heller-Strasse 3, Brunswik, Kiel
Studienzentrum Dr. Bischof GmbH
N/A, Konrad-Zuse-Strasse 14, West, Boeblingen
ZNS GmbH Zentrum fuer Neurologisch-Psychiatrische Studien Gutachten und medizinische Fortbildung Siegen
N/A, Weidenauer Strasse 120, Weidenau, Siegen
Studienzentrum Nord-West
N/A, Kuhlenstraße 2, 26655, Westerstede
FutureMeds GmbH
N/A, Platz Der Deutschen Einheit 4, 63065, Offenbach Am Main
Centrum Medyczne Neuromed Sp. z o.o.
N/A, Ul. Jana Biziela 14, 85-163, Bydgoszcz
Revit Sp. z o.o.
N/A, Ul. Swobodna 38, 15-756, Bialystok
Ilkowski I Partnerzy sp.p. Lekarzy
N/A, Ul. Wierzbowa 2/2, 61-853, Poznan
Santa Sp. z o.o.
N/A, Ul. Pilota Stanislawa Wigury 19, 90-302, Lodz
Neuro-Care Sp. z o.o. sp.k.
N/A, Ul. Pawla Kolodzieja 8, 40-749, Katowice
Diamond Clinic Sp. z o.o.
N/A, Ul. Stefana Rogozinskiego 6/U3, 31-559, Cracow
Centrum Badan Klinicznych Pi-House Sp. z o.o.
N/A, Ul. Na Zaspe 3, 80-546, Gdansk
Medicover Integrated Clinical Services Sp. z o.o.
NA, Ul. Chlodna 52, 00-872, Warsaw
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 |
|---|---|---|---|---|---|
| Germany | 2025-06-03 | 2026-02-24 | 2025-06-12 | 2025-10-18 | |
| Poland | 2025-06-10 | 2026-04-07 | 2025-06-27 | 2025-10-18 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 30 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-513435-24-01_Redacted | d |
| Protocol (for publication) | D4_Patient Facing Documents_Copyright Template | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangments_PL | 1 |
| Recruitment arrangements (for publication) | K2_CL_EC Doc_Recruitment_DE_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_CL_EC_Notes_EN_Redacted | 6 |
| Recruitment arrangements (for publication) | K2_Letter-Doctor-Referral_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Poster_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CYAB_EC Document Recruitment_PL_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CYAB_Poster_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CYAB_Trial Awareness Brochure_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Letter Doctor Referral_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_recruitment texts_site_Redacted | 1.2 |
| Recruitment arrangements (for publication) | K2_Thank-You-Screening | 3 |
| Recruitment arrangements (for publication) | K2_Trial-Awareness-Brochure_Redacted | 1 |
| Recruitment arrangements (for publication) | K4_Recruitment arrangments_Informed consent and patient recruitment procedure_PL | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PL_Main ICF_CYAB_Redacted | 4 |
| Subject information and informed consent form (for publication) | L2_CA_Guide_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Compensation Information Sheet_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_EMPH_PatientInstructionsForUse_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_EPGuide_QuickReference_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_EPGuide_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_EPGuide_Smart_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Lotus Subject Education Video Script_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Emergency Card CYAB_Poland | 1 |
| Subject information and informed consent form (for publication) | L3_Patient Contact Card | 2 |
| Subject information and informed consent form (for publication) | L5_Info Re insurance Conditions for Patient | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-513435-24-01_PL_Redacted | c |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-513435-24-01_Redacted_ENG | c |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-02-14 | Germany | Acceptable 2025-05-23
|
2025-05-23 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-06-13 | Acceptable 2025-05-23
|
2025-06-13 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-07-25 | Germany | Acceptable | 2025-08-08 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-09-19 | Acceptable | 2025-10-29 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-11-13 | Germany | Acceptable | 2025-11-13 |