Clinical trial • Phase II • Respiratory
LY3537031 for Asthma
Phase II trial of LY3537031 for Asthma.
Overview
- Trial Therapeutic Area
- Respiratory
- Trial Disease
- Asthma
- Trial Stage
- Phase II
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 26-09-2025
- First CTIS Authorization Date
- 21-01-2026
Trial design
Randomised, brenipatide (investigational product ly3537031, subcutaneous injection) versus placebo to match ly (placebo arm). dose and dosing schedule are not specified in the provided data.-controlled Phase II trial across 28 sites in France, Germany, Netherlands and others.
- Randomised
- Yes
- Comparator
- Brenipatide (investigational product LY3537031, subcutaneous injection) versus Placebo to match LY (placebo arm). Dose and dosing schedule are not specified in the provided data.
- Target Sample Size
- 401
- Trial Duration For Participant
- 364
Eligibility
Recruits 401 Vulnerable population selected (isVulnerablePopulationSelected = true). Multiple subject information and informed consent documents provided (main ICF, genetic addenda, eConsent/eSignature materials). Specific consent/assent handling for vulnerable participants is not described in the provided data..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected = true). Multiple subject information and informed consent documents provided (main ICF, genetic addenda, eConsent/eSignature materials). Specific consent/assent handling for vulnerable participants is not described in the provided data.
Inclusion criteria
- {"criterion_text":"- 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\n- 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
- {"criterion_text":"- Participants must not have a Diagnosis of job-related asthma\n- 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 endpoints
- {"endpoint_text":"- Annualized Asthma Exacerbation Rate Over 52 Weeks of treatment to assess the asthma exacerbation rate. [Time Frame: Baseline to Week 52]","definition_or_measurement_approach":"Annualized asthma exacerbation rate measured over Baseline to Week 52. [Time Frame: Baseline to Week 52]"}
Recruitment
- Registry Or Advocacy Recruitment
- True, Trialbee (patient referral/recruitment vendor) and GAAPP (advocacy toolkit referenced) are named in recruitment materials.
- Digital Remote Recruitment
- True, the study uses digital/remote methods including Trialbee digital marketing content, Link2Trials social media tools, landing pages, and IQVIA eConsent/eSignature remote consent materials.
- Planned Sample Size
- 401
- Recruitment Window Months
- 28
- Consent Approach
- Informed consent obtained from adult participants. Multiple subject information sheets and informed consent forms (L1 main ICF, genetic addenda) are provided; eConsent, eSignature and remote consent guidance and participant-facing screenshots/documents available. Materials and translations exist (English and translations noted in Dutch, French, Polish). No assent for minors is described.
Methods
- Digital/social media recruitment: Trialbee and Link2Trials digital marketing content and social media recruitment tools targeting adults with asthma (documents: Trialbee Digital Marketing Content, Link2Trials social media recruitment tools).
- Doctor referral: 'Doctor-to-Patient' letters and doctor referral materials to recruit patients via clinicians.
- Printed materials: Flyers, Posters, Brochures (including 'Understanding Asthma' brochure and 'GI-AE' brochure) distributed to potential participants/patient audiences.
- Patient-facing landing pages and eConsent: IQVIA eConsent and participant-facing landing pages and screenshots to enable remote recruitment and consent.
- Third-party recruitment vendors: Trialbee and other recruitment partners contracted for patient referral, recruitment, screening and retention.
Geography
- Total Number Of Sites
- 28
- Total Number Of Participants
- 137
France
- Earliest CTIS Part Ii Submission Date
- 15-12-2025
- Latest Decision Or Authorization Date
- 21-01-2026
- Processing Time Days
- 37
- Number Of Sites
- 10
- Number Of Participants
- 40
Sites
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Pneumology
- Principal Investigator Name
- Pierre-Olivier Girodet
- Principal Investigator Email
- pierre-olivier.girodet@u-bordeaux.fr
- Contact Person Name
- Pierre-Olivier Girodet
- Contact Person Email
- pierre-olivier.girodet@u-bordeaux.fr
- Site Name
- Centre Hospitalier Universitaire De Rennes
- Department Name
- Pneumology
- Principal Investigator Name
- Chantal Belleguic
- Principal Investigator Email
- chantal.belleguic@chu-rennes.fr
- Contact Person Name
- Chantal Belleguic
- Contact Person Email
- chantal.belleguic@chu-rennes.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Pneumology
- Principal Investigator Name
- Antoine Beurnier
- Principal Investigator Email
- antoine.beurnier@aphp.fr
- Contact Person Name
- Antoine Beurnier
- Contact Person Email
- antoine.beurnier@aphp.fr
- Site Name
- Hospital Foch
- Department Name
- Pneumology
- Principal Investigator Name
- Céline Goyard
- Principal Investigator Email
- c.goyard@hopital-foch.com
- Contact Person Name
- Céline Goyard
- Contact Person Email
- c.goyard@hopital-foch.com
- Site Name
- Groupe Hospitalier Intercommunal Le Raincy Montfermeil
- Principal Investigator Name
- Cyril Maurer
- Principal Investigator Email
- cyril.maurer@ght-gpne.fr
- Contact Person Name
- Cyril Maurer
- Contact Person Email
- cyril.maurer@ght-gpne.fr
- Site Name
- Centre Hospitalier De Cholet
- Department Name
- Pneumology
- Principal Investigator Name
- Pauline Beurrier
- Principal Investigator Email
- pauline.beurrier@ch-cholet.fr
- Contact Person Name
- Pauline Beurrier
- Contact Person Email
- pauline.beurrier@ch-cholet.fr
- Site Name
- Centre Hospitalier Regional Et Universitaire De Brest
- Department Name
- Clinical Investigation Centre
- Principal Investigator Name
- Raphael Le Mao
- Principal Investigator Email
- raphael.lemao@chu-brest.fr
- Contact Person Name
- Raphael Le Mao
- Contact Person Email
- raphael.lemao@chu-brest.fr
- Site Name
- Centre Hospitalier De Versailles
- Department Name
- Pneumology
- Principal Investigator Name
- Gilles Garcia
- Principal Investigator Email
- ggarcia@ght78sud.fr
- Contact Person Name
- Gilles Garcia
- Contact Person Email
- ggarcia@ght78sud.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Clinical Investigation Centre
- Principal Investigator Name
- Camille Taillé
- Principal Investigator Email
- camille.taille@aphp.fr
- Contact Person Name
- Camille Taillé
- Contact Person Email
- camille.taille@aphp.fr
- Site Name
- Centre Hospitalier Du Pays D Aix Centre Hospitalier Intercommunal Aix-Pertuis
- Department Name
- Respiratory disease department
- Principal Investigator Name
- Youssef TRIGUI
- Principal Investigator Email
- ytrigui@ch-aix.fr
- Contact Person Name
- Youssef TRIGUI
- Contact Person Email
- ytrigui@ch-aix.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 18-12-2025
- Latest Decision Or Authorization Date
- 21-01-2026
- Processing Time Days
- 34
- Number Of Sites
- 8
- Number Of Participants
- 33
Sites
- Site Name
- KPPK GmbH
- Principal Investigator Name
- Olaf Schmidt
- Principal Investigator Email
- schmidt@kppk-gmbh.de
- Contact Person Name
- Olaf Schmidt
- Contact Person Email
- schmidt@kppk-gmbh.de
- Site Name
- IKF Pneumologie GmbH & Co. KG (Frankfurt Am Main)
- Department Name
- Pulmonology, Endocrinology, Cardiovascular Diseases
- Principal Investigator Name
- Andreas Eich
- Principal Investigator Email
- eich@ikf-pneumologie.de
- Contact Person Name
- Andreas Eich
- Contact Person Email
- eich@ikf-pneumologie.de
- Site Name
- Studienpraxis Berlin-Brandenburg Cornelia Seelbinder Und Lennart Schaper GbR
- Principal Investigator Name
- Lennart Schaper
- Principal Investigator Email
- lennart.schaper@studienpraxis-bb.de
- Contact Person Name
- Lennart Schaper
- Contact Person Email
- lennart.schaper@studienpraxis-bb.de
- Site Name
- Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH
- Principal Investigator Name
- Sivagurunathan Sutharsan
- Principal Investigator Email
- sivagurunathan.sutharsan@rlk.uk-essen.de
- Contact Person Name
- Sivagurunathan Sutharsan
- Contact Person Email
- sivagurunathan.sutharsan@rlk.uk-essen.de
- Site Name
- POIS Sachsen GmbH
- Department Name
- Pneumologisch/onkologisch/internistisches Studienzentrum
- Principal Investigator Name
- Juliana Brode
- Principal Investigator Email
- j.brode@pois-sachsen.de
- Contact Person Name
- Juliana Brode
- Contact Person Email
- j.brode@pois-sachsen.de
- Site Name
- IKF Pneumologie GmbH & Co. KG (Mainz)
- Principal Investigator Name
- Stephanie Korn
- Principal Investigator Email
- korn@ikf-pneumologie.de
- Contact Person Name
- Stephanie Korn
- Contact Person Email
- korn@ikf-pneumologie.de
- Site Name
- Dedicated Research Site FutureMeds
- Principal Investigator Name
- Christel Contzen
- Principal Investigator Email
- christel.contzen@globalaes.com
- Contact Person Name
- Christel Contzen
- Contact Person Email
- christel.contzen@globalaes.com
- Site Name
- Me Clinical Respiratory Research Hamburg GmbH
- Principal Investigator Name
- Martin Ehlers
- Principal Investigator Email
- martin.ehlers@clinical-respiratory-research.com
- Contact Person Name
- Martin Ehlers
- Contact Person Email
- martin.ehlers@clinical-respiratory-research.com
Netherlands
- Earliest CTIS Part Ii Submission Date
- 15-01-2026
- Latest Decision Or Authorization Date
- 08-05-2026
- Processing Time Days
- 113
- Number Of Sites
- 6
- Number Of Participants
- 36
Sites
- Site Name
- Amphia Hospital
- Department Name
- Longgeneeskunde
- Principal Investigator Name
- Simone van der Sar - Brugge
- Principal Investigator Email
- svandersar@amphia.nl
- Contact Person Name
- Simone van der Sar - Brugge
- Contact Person Email
- svandersar@amphia.nl
- Site Name
- Isala Klinieken Stichting
- Department Name
- Poli Longziekten
- Principal Investigator Name
- Kornelis Patberg
- Principal Investigator Email
- k.w.patberg@isala.nl
- Contact Person Name
- Kornelis Patberg
- Contact Person Email
- k.w.patberg@isala.nl
- Site Name
- EB FlevoResearch B.V.
- Principal Investigator Name
- Mazin Alhakim
- Principal Investigator Email
- m.alhakim@flevoresearch.com
- Contact Person Name
- Mazin Alhakim
- Contact Person Email
- m.alhakim@flevoresearch.com
- Site Name
- Canisius Wilhelmina Ziekenhuis
- Department Name
- Pulmonology
- Principal Investigator Name
- Juergen Hoelters
- Principal Investigator Email
- jurgen.holters@cwz.nl
- Contact Person Name
- Juergen Hoelters
- Contact Person Email
- jurgen.holters@cwz.nl
- Site Name
- Sint Franciscus Vlietland Groep Stichting
- Department Name
- Longziekten
- Principal Investigator Name
- Gert-Jan Braunstahl
- Principal Investigator Email
- g.braunstahl@franciscus.nl
- Contact Person Name
- Gert-Jan Braunstahl
- Contact Person Email
- g.braunstahl@franciscus.nl
- Site Name
- Gelre Hospitals
- Department Name
- Longresearch
- Principal Investigator Name
- Martijn Goosens
- Principal Investigator Email
- goosens.research@gelre.nl
- Contact Person Name
- Martijn Goosens
- Contact Person Email
- goosens.research@gelre.nl
Poland
- Earliest CTIS Part Ii Submission Date
- 23-01-2026
- Latest Decision Or Authorization Date
- 11-05-2026
- Processing Time Days
- 108
- Number Of Sites
- 4
- Number Of Participants
- 28
Sites
- Site Name
- Alergologia Plus Sp. z o.o.
- Principal Investigator Name
- Michał Springer
- Principal Investigator Email
- michal.springer.pl@gmail.com
- Contact Person Name
- Michał Springer
- Contact Person Email
- michal.springer.pl@gmail.com
- Site Name
- Centrum Medyczne All-Med Badania Kliniczne
- Principal Investigator Name
- Grażyna Pulka
- Principal Investigator Email
- pulkaallmed@gmail.com
- Contact Person Name
- Grażyna Pulka
- Contact Person Email
- pulkaallmed@gmail.com
- Site Name
- Specjalistyczna Przychodnia Lekarska Alergo Med Sp. z o.o.
- Principal Investigator Name
- Danuta Mądra-Rogacka
- Principal Investigator Email
- dmadrarogacka@gmail.com
- Contact Person Name
- Danuta Mądra-Rogacka
- Contact Person Email
- dmadrarogacka@gmail.com
- Site Name
- Diamond Clinic Sp. z o.o.
- Principal Investigator Name
- Barbara Rewerska
- Principal Investigator Email
- barbara@diamondclinic.eu
- Contact Person Name
- Barbara Rewerska
- Contact Person Email
- barbara@diamondclinic.eu
Sponsor
Primary sponsor
- Full Name
- Eli Lilly & Co.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Icon Clinical Research Limited
- Responsibilities
- code:6
- Name
- IQVIA Limited
- Responsibilities
- Site Regulatory Readiness; code:15 and code:1 responsibilities listed
- Name
- Labcorp Drug Devlopment Inc
- Responsibilities
- code:4
- Name
- Medidata Solutions Inc.
- Responsibilities
- code:7
- Name
- PPD Global Central Labs
- Responsibilities
- code:4
Third parties
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"code:7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Drug Devlopment Inc","duties_or_roles":"code:4","organisation_type":"Health care"}
- {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
- {"country":"Sweden","full_name":"Trialbee AB","duties_or_roles":"Patient Referral, Recruitment, Screening, and/or retention.","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Drug Devlopment Inc","duties_or_roles":"code:4","organisation_type":"Health care"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"code:6","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"The Hibbert group","duties_or_roles":"Patient Screening Recruitment, and/or Retention","organisation_type":"Health care"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Site Regulatory Readiness","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"code:1","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient Reimbursement and Travel Services","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Cleveland Clinic Foundation","duties_or_roles":"code:6","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"code:6","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Brenipatide
- Active Substance
- LY3537031
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS USE
- Route
- Subcutaneous
- Authorisation Status
- prodAuthStatus:1
- Investigational Product Name
- Placebo to match LY
- Modality
- Other
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