Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
538
Countries
4
Sites
28
Asthma
To evaluate the efficacy of brenipatide relative to placebo in reducing severe asthma exacerbations
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 13 Feb 2026 → ongoing
- Decision date (initial)
- 2026-01-21
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2025-522640-41-00
- WHO UTN
- U1111-1325-5672
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Pharmacogenetic, Safety, Pharmacodynamic, Therapy, Pharmacokinetic, Dose response
To evaluate the efficacy of brenipatide relative to placebo in reducing severe asthma exacerbations
Conditions and MedDRA coding
Asthma
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- Yes
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Participants must have been diagnosed with asthma and have received an asthma controller medication prescribed by their doctor for at least 12 months prior to screening
- Participants must have a history of 1 severe asthma exacerbation that led to oral steroid treatment in the last 12 months prior to screening
Exclusion criteria 2
- Participants must not have a Diagnosis of job-related asthma
- Participants must not have a Lung condition other than asthma, such as smoker’s lung, infections that has been going on for a long time or didn’t go away completely
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Annualized Asthma Exacerbation Rate Over 52 Weeks of treatment to assess the asthma exacerbation rate. [Time Frame: Baseline to Week 52]
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
PRD12713220 · Product
- Active substance
- LY3537031
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD12713219 · Product
- Active substance
- LY3537031
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD12713221 · Product
- Active substance
- LY3537031
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD12713222 · Product
- Active substance
- LY3537031
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 1 Day(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 |
|---|---|---|
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | E-data capture |
| Labcorp Drug Devlopment Inc ORL-000016014
|
Greenfield, United States | Laboratory analysis |
| Bioagilytix Labs LLC ORG-100013030
|
Durham, United States | Laboratory analysis |
| Trialbee AB ORG-100051369
|
Malmo, Sweden | Other |
| Labcorp Drug Devlopment Inc ORL-000016013
|
United States | Laboratory analysis |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Data management |
| The Hibbert group ORL-000016015
|
Trenton, United States | Other |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | Other |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| PPD Global Central Labs ORG-100046496
|
Zaventem, Belgium | Laboratory analysis |
| Cleveland Clinic Foundation ORG-100028017
|
Cleveland, United States | Data management |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Data management |
Locations
4 EU/EEA countries · 28 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 40 | 10 |
| Germany | Ongoing, recruiting | 33 | 8 |
| Netherlands | Authorised, recruitment pending | 36 | 6 |
| Poland | Ongoing, recruiting | 28 | 4 |
| Rest of world
Canada, Brazil, Mexico, India, United States, China, Japan, Argentina
|
— | 401 | — |
Investigational sites
Centre Hospitalier Regional Et Universitaire De Brest
Clinical Investigation Centre, Boulevard Tanguy Prigent, 29200, Brest
Centre Hospitalier Universitaire De Bordeaux
Pneumology, Avenue De Magellan, 33600, Pessac
Centre Hospitalier De Versailles
Pneumology, 177 Rue De Versailles, Bp 673 Le Chesnay Rocquencourt, Le Chesnay Cedex
Hospital Foch
Pneumology, 40 Rue Worth, 92150, Suresnes
Centre Hospitalier De Cholet
Pneumology, 1 Rue De Marengo, 49300, Cholet
Centre Hospitalier Du Pays D Aix Centre Hospitalier Intercommunal Aix-Pertuis
Respiratory disease department, Avenue Des Tamaris, 13100, Aix En Provence
Groupe Hospitalier Intercommunal Le Raincy Montfermeil
N/A, 10 Rue Du General Leclerc, 93370, Montfermeil
Centre Hospitalier Universitaire De Rennes
Pneumology, 2 Rue Henri Le Guilloux, 35000, Rennes
Assistance Publique Hopitaux De Paris
Pneumology, 78 Rue Du General Leclerc, 94270, Le Kremlin-Bicetre
Assistance Publique Hopitaux De Paris
Clinical Investigation Centre, 46 Rue Henri Huchard, 75877, Paris Cedex 18
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH
N/A, Tueschener Weg 40, Heidhausen, Essen
POIS Sachsen GmbH
Pneumologisch/onkologisch/internistisches Studienzentrum, Foepplstrasse 5, Schoenefeld-Abtnaundorf, Leipzig
Studienpraxis Berlin-Brandenburg Cornelia Seelbinder Und Lennart Schaper GbR
N/A, Torstrasse 117, Mitte, Berlin
KPPK GmbH
N/A, Hauptstrasse 175, 56170, Bendorf
IKF Pneumologie GmbH & Co. KG
N/A, Haifa-Allee 24, Bretzenheim, Mainz
IKF Pneumologie GmbH & Co. KG
Pulmonology, Endocrinology, Cardiovascular Diseases, 2nd Floor, Schaumainkai 101-103, Frankfurt Am Main
Me Clinical Respiratory Research Hamburg GmbH
N/A, Dorotheenstrasse 174, Winterhude, Hamburg
Dedicated Research Site FutureMeds
N/A, Platz der Deutschen Einheit 4, Hessen, Offenbach
Amphia Hospital
Longgeneeskunde, Molengracht 21, 4818 CK, Breda
Sint Franciscus Vlietland Groep Stichting
Longziekten, Kleiweg 500, 3045 PM, Rotterdam
Gelre Hospitals
Longresearch, Den Elterweg 77, 7207 AE, Zutphen
Canisius Wilhelmina Ziekenhuis
Pulmonology, Weg Door Jonkerbos 100, 6532 SZ, Nijmegen
EB FlevoResearch B.V.
NA, Louis Armstrongweg 88, 1311 RL, Almere
Isala Klinieken Stichting
Poli Longziekten, Dokter Van Heesweg 2, 8025 AB, Zwolle
Centrum Medyczne All-Med Badania Kliniczne
NA, Ul. Henryka Sienkiewicza 23, 30-033, Cracow
Alergologia Plus Sp. z o.o.
NA, Ul. Tomasza Drobnika 49, 60-693, Poznan
Specjalistyczna Przychodnia Lekarska Alergo Med Sp. z o.o.
NA, Ul Mieczyslawa Niedzialkowskiego 10a/50, 61-578, Poznan
Diamond Clinic Sp. z o.o.
NA, Ul. Stefana Rogozinskiego 6/U3, 31-559, Cracow
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 |
|---|---|---|---|---|---|
| France | 2026-03-31 | 2026-04-23 | |||
| Germany | 2026-02-19 | 2026-03-05 | |||
| Poland | 2026-02-13 | 2026-02-18 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 81 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2025-522640-41-00 _Redacted | b |
| Protocol (for publication) | D4_Patient facing documents_Copyright Statement | 1.0 |
| Recruitment arrangements (for publication) | _IRB or IEC Submission Documentation U-EN 2 0 15 Dec 2025 | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangement_Netherlands_Redacted | 3.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangments__PL | 1 |
| Recruitment arrangements (for publication) | K2_Document additionnel | 1.0 |
| Recruitment arrangements (for publication) | K2_recruitment material_Brochure Master_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_recruitment material_Brochure_Master_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_Master_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Brochure_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CT_GI-AE-Brochure_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CT_Understanding-Asthma-Brochure_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Doctor Referral_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_recruitment material_Doctor to Patient letter_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_recruitment material_Flyer_Master_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer_Master_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_recruitment material_Flyer_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Flyer_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_GI AE Brochure | 1 |
| Recruitment arrangements (for publication) | K2_recruitment material_GI-AE-Brochure | 1 |
| Recruitment arrangements (for publication) | K2_recruitment material_GI-AE-Brochure_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Global Privacy Policy_Netherlands_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Letter-Doctor-to-Patient_Master_redacted | 1 |
| Recruitment arrangements (for publication) | K2_recruitment material_Letter-Doctor-to-Patient_Redacted | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Link2Trials social media recruitment tools ASTMA_EB Medical_Redacted | 2 |
| Recruitment arrangements (for publication) | K2_recruitment material_Poster_Master_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_Master_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_recruitment material_Poster_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Poster_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Proposal Link2Trials_EB Medical_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_recruitment material_Trialbee_Digital Marketing Content_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Trialbee_Digital Marketing Content_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee_Digital Marketing Content_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_recruitment material_Trialbee_GAAPP Advocacy Toolkit_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Trialbee_GAAPP Advocacy Toolkit_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee_GAAPP Advocacy Toolkit_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee_Global Privacy Policy | 1 |
| Recruitment arrangements (for publication) | K2_recruitment material_Trialbee_Global Privacy Policy | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Trialbee_Landing Page_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee_OverviewSupplementary Information | 1 |
| Recruitment arrangements (for publication) | K2_recruitment material_Trialbee_OverviewSupplementaryInformation | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Trialbee_OverviewSupplementaryInformation_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_recruitment material_Trialbee_Secondary Assessment_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Trialbee_Secondary Assessment_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee_Secondary Assessment_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee_Self__Assessment | 1 |
| Recruitment arrangements (for publication) | K2_recruitment material_Trialbee_Self_Assessment | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Trialbee_Self_Assessment_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Understanding Asthma Brochure | 1 |
| Recruitment arrangements (for publication) | K2_recruitment material_Understanding-Asthma-Brochure | 1 |
| Recruitment arrangements (for publication) | K2_recruitment material_Understanding-Asthma-Brochure_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Wervingstekst en beelden voor de rekruteringscampagne Lilly Astma_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_GZMR_ICF Addendum_Genetic_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_GZMR_ICF Addendum_Genetic_v1 1_TC_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_GZMR_main ICF_v1 1_TC_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_GZMR_main ICFc_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Complete Consent Remote Consent Tracking Quick Reference Guide | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_eConsent System_Response to 2nd round of RFI | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_eSignature In-Person Consent Quick Reference Guide | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_IQVIA Complete Consent - Participant-Facing Screenshots_Redacted | 1.4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_IQVIA Complete Consent Security and Privacy Quick Reference Guide_Redacted | 1.5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_IQVIA E2E Privacy Policy_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_IQVIA eConsent Submission Letter_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_IQVIA Getting Started Patient-facing Getting Started landing page | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Redacted | 1.6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Blood Sampling for Genetic Research_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PL_Main ICF_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Confidentiality Notice_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Card | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study Participant Contact Card | 1 |
| Subject information and informed consent form (for publication) | L2_Recruitment arrangments_Informed consent and patient recruitment procedure_PL | 2 |
| Subject information and informed consent form (for publication) | L3_Info Re insurance Conditions for Patient | 1 |
| Subject information and informed consent form (for publication) | L3_Subject Instructions for Use IFU_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2025-522640-41-00_FR_Redacted | b |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-522640-41-00_NL_Redacted | b |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-522640-41-00_PL_Redacted | b |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2025-522640-41-00_Redacted_ENG | b |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-09-26 | Germany | Acceptable 2026-01-20
|
2026-01-21 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-02-26 | Acceptable | 2026-05-08 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-04-09 | Acceptable | 2026-05-11 |