Clinical trial • Phase III • Gastroenterology
GLEPAGLUTIDE for Short bowel syndrome (intestinal failure)
Phase III trial of GLEPAGLUTIDE for Short bowel syndrome (intestinal failure).
Overview
- Trial Therapeutic Area
- Gastroenterology
- Trial Disease
- Short bowel syndrome (intestinal failure)
- Trial Stage
- Phase III
- Drug Modality
- Peptide/protein/enzyme | Other
Key dates
- Initial CTIS Submission Date
- 27-08-2025
- First CTIS Authorization Date
- 04-12-2025
Trial design
Randomised, placebo for glepaglutide (placebo comparator); active treatment: glepaglutide 10 mg, administered twice-weekly (subcutaneous).-controlled Phase III trial in France, Netherlands, Denmark and others.
- Randomised
- Yes
- Comparator
- Placebo for glepaglutide (placebo comparator); active treatment: Glepaglutide 10 mg, administered twice-weekly (subcutaneous).
- Target Sample Size
- 24
- Trial Duration For Participant
- 364
Eligibility
Recruits 24 Vulnerable population selected. Participants must provide signed informed consent; eligible ages are 18 to 90 years (adults only). Country-specific subject information and informed consent forms (including pregnancy/partner and long-term sample storage ICFs) are provided; no assent procedures for minors are described..
- Vulnerable Population
- Vulnerable population selected. Participants must provide signed informed consent; eligible ages are 18 to 90 years (adults only). Country-specific subject information and informed consent forms (including pregnancy/partner and long-term sample storage ICFs) are provided; no assent procedures for minors are described.
Inclusion criteria
- {"criterion_text":"- •\tsigned informed consent;"}
- {"criterion_text":"- •\tage of 18 to 90 years;"}
- {"criterion_text":"- •\ta diagnosis of SBS, defined as having a small bowel with an estimated length of less than 200 cm (equal to 79 inches) in continuity (latest intestinal resection ≥6 months before screening);"}
- {"criterion_text":"- •\tstable PS need of ≥3 days per week;"}
- {"criterion_text":"- •\tno restorative surgery planned during the trial period;"}
- {"criterion_text":"- •\thaving a stoma or colon in continuity"}
Exclusion criteria
- {"criterion_text":"- •\tmore than 2 SBS- or PS-related hospitalizations within 6 months before screening;"}
- {"criterion_text":"- •\tpoorly controlled IBD that is moderately or severely active or a fistula that can interfere with the measurements or examinations required in the trial;"}
- {"criterion_text":"- •\ta history of colorectal cancer or any other type of cancer (except for margin-free resected cutaneous basal, squamous cell carcinoma or adequately treated in situ cervical cancer) unless the patient has been disease-free for at least 5 years; ongoing bowel obstruction;"}
- {"criterion_text":"- •\tBMI <18.5 kg/m2."}
Endpoints
Primary endpoints
- {"endpoint_text":"- 1. Change in weekly PS volume from baseline to Week 24","definition_or_measurement_approach":"Change in weekly parenteral support (PS) volume measured from baseline to Week 24 (weekly PS volume as recorded per protocol)."}
Secondary endpoints
- {"endpoint_text":"- 1. Reduction of at least 20% in weekly PS volume from baseline to Week 52","definition_or_measurement_approach":"Proportion of patients achieving ≥20% reduction in weekly PS volume from baseline to Week 52 (weekly PS volume comparison)."}
- {"endpoint_text":"- 2. Reduction in days on PS ≥1 day/week from baseline to Week 52","definition_or_measurement_approach":"Change in number of days on PS per week (≥1 day/week threshold) from baseline to Week 52."}
- {"endpoint_text":"- 3. Reduction of 100% weekly PS volume (weaned-off) from baseline to Week 52","definition_or_measurement_approach":"Proportion of patients completely weaned off PS (100% reduction in weekly PS volume) from baseline to Week 52."}
- {"endpoint_text":"- 4. Achieving ‘much better’ PGIC status at Week 24","definition_or_measurement_approach":"Patient Global Impression of Change (PGIC) assessment at Week 24; achieving response category 'much better'."}
- {"endpoint_text":"- 5. Clinical response, defined as achieving at least 20% reduction in weekly PS volume from baseline to both Week 20 and Week 24","definition_or_measurement_approach":"Clinical response defined by ≥20% reduction in weekly PS volume versus baseline at both Week 20 and Week 24."}
- {"endpoint_text":"- 6. Reduction in days on PS ≥1 day/week from baseline to Week 24","definition_or_measurement_approach":"Change in number of days on PS per week (≥1 day/week threshold) from baseline to Week 24."}
- {"endpoint_text":"- 7. Reduction of 100% weekly PS volume (weaned-off) from baseline to Week 24","definition_or_measurement_approach":"Proportion of patients completely weaned off PS (100% reduction in weekly PS volume) from baseline to Week 24."}
- {"endpoint_text":"- 8. Change in weekly PS volume from baseline to Week 12","definition_or_measurement_approach":"Change in weekly PS volume from baseline to Week 12."}
- {"endpoint_text":"- 9. Change in weekly PS volume from baseline to Week 8","definition_or_measurement_approach":"Change in weekly PS volume from baseline to Week 8."}
- {"endpoint_text":"- 10. TEAEs from baseline to Week 52","definition_or_measurement_approach":"Treatment-emergent adverse events (TEAEs) recorded from baseline through Week 52."}
Recruitment
- Registry Or Advocacy Recruitment
- True - Site and Patient-advocacy-Contact-List-for-ICF_AT_Public
- Planned Sample Size
- 24
- Recruitment Window Months
- 73
- Consent Approach
- Signed informed consent required from each participant (age 18–90). Country-specific subject information and informed consent forms are provided in multiple languages (examples include French, Czech, Dutch, Danish, Swedish, Polish, Italian, German, Spanish, Finnish, Hungarian, English). Separate ICFs exist for pregnancy/partner, long-term sample storage and travel/reimbursement where applicable.
Methods
- Country-specific recruitment arrangements documents (K1) and patient leaflets (K2) published for multiple countries indicating site-led recruitment and information leaflets.
- Advertisements for subject recruitment (country-specific advertisement PDFs for Sweden, Norway, Belgium, Italy, etc.).
- GP / Dr-to-Dr referral letters (country-specific GP notification/Dr-to-Dr referral documents e.g. Hungary, Italy).
- Patient travel and reimbursement information provided (country-specific travel/reimbursement ICFs).
- Site and patient-advocacy contact lists provided (document: Site and Patient-advocacy-Contact-List-for-ICF_AT_Public).
Geography
- Total Number Of Sites
- 27
- Total Number Of Participants
- 67
France
- Earliest CTIS Part Ii Submission Date
- 04-12-2025
- Latest Decision Or Authorization Date
- 27-03-2026
- Processing Time Days
- 113
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Department of Gastroenterology, IBD and Nutrition
- Principal Investigator Name
- Francisca JOLY
- Principal Investigator Email
- francisca.joly@aphp.fr
- Contact Person Name
- Francisca JOLY
- Contact Person Email
- francisca.joly@aphp.fr
Netherlands
- Earliest CTIS Part Ii Submission Date
- 09-12-2025
- Latest Decision Or Authorization Date
- 02-04-2026
- Processing Time Days
- 114
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Radboud universitair medisch centrum Stichting
- Department Name
- Gastroenterology
- Principal Investigator Name
- Geert Wanten
- Principal Investigator Email
- geert.wanten@radboudumc.nl
- Contact Person Name
- Geert Wanten
- Contact Person Email
- geert.wanten@radboudumc.nl
Denmark
- Earliest CTIS Part Ii Submission Date
- 08-12-2025
- Latest Decision Or Authorization Date
- 29-03-2026
- Processing Time Days
- 111
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Rigshospitalet
- Department Name
- Department of Digestive diseases, Transplantation and General Surgery
- Principal Investigator Name
- Palle Bekker Jeppesen
- Principal Investigator Email
- palle.bekker.jeppesen@regionh.dk
- Contact Person Name
- Palle Bekker Jeppesen
- Contact Person Email
- palle.bekker.jeppesen@regionh.dk
Sweden
- Earliest CTIS Part Ii Submission Date
- 09-12-2025
- Latest Decision Or Authorization Date
- 02-04-2026
- Processing Time Days
- 114
- Number Of Sites
- 2
- Number Of Participants
- 5
Sites
- Site Name
- Sahlgrenska University Hospital-Vaestra Goetalandsregionen
- Department Name
- Mag- och tarmlaboratorium Sahlgrenska Universitetssjukhus Blå stråket 3,Plan 4
- Principal Investigator Name
- Jonas Varkey
- Principal Investigator Email
- jonas.varkey@vgregion.se
- Contact Person Name
- Jonas Varkey
- Contact Person Email
- jonas.varkey@vgregion.se
- Site Name
- Karolinska University Hospital
- Department Name
- IBD Mag- och tarmmottagning Solna B04:09
- Principal Investigator Name
- Stephan Haas
- Principal Investigator Email
- stephan.haas@regionstockholm.se
- Contact Person Name
- Stephan Haas
- Contact Person Email
- stephan.haas@regionstockholm.se
Poland
- Earliest CTIS Part Ii Submission Date
- 22-12-2025
- Latest Decision Or Authorization Date
- 31-03-2026
- Processing Time Days
- 99
- Number Of Sites
- 2
- Number Of Participants
- 11
Sites
- Site Name
- Wojewodzki Specjalistyczny Szpital Im. M. Pirogowa W Lodzi
- Department Name
- Centrum Leczenia Żywieniowego
- Principal Investigator Name
- Marek Kunecki
- Principal Investigator Email
- marek.kunecki@vp.pl
- Contact Person Name
- Marek Kunecki
- Contact Person Email
- marek.kunecki@vp.pl
- Site Name
- Samodzielny Publiczny Szpital Kliniczny Im. Prof. W. Orlowskiego CMKP
- Department Name
- Oddział Kliniczny Chirurgii Ogólnej i Żywienia Klinicznego
- Principal Investigator Name
- Joanna Kaczanowska
- Principal Investigator Email
- gomasia@tlen.pl
- Contact Person Name
- Joanna Kaczanowska
- Contact Person Email
- gomasia@tlen.pl
Italy
- Earliest CTIS Part Ii Submission Date
- 16-12-2025
- Latest Decision Or Authorization Date
- 01-04-2026
- Processing Time Days
- 106
- Number Of Sites
- 3
- Number Of Participants
- 5
Sites
- Site Name
- Azienda Ospedaliera di Padova
- Department Name
- UOC di Gastroenterologia
- Principal Investigator Name
- Brigida Barberio
- Principal Investigator Email
- brigida.barberio@unipd.it
- Contact Person Name
- Brigida Barberio
- Contact Person Email
- brigida.barberio@unipd.it
- Site Name
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- Department Name
- UOC Gastroenterologia Endoscopica
- Principal Investigator Name
- Luca Elli
- Principal Investigator Email
- luca.elli@policlinico.mi.it
- Contact Person Name
- Luca Elli
- Contact Person Email
- luca.elli@policlinico.mi.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- UOC Gastroenterologia
- Principal Investigator Name
- Giovanni Cammarota
- Principal Investigator Email
- giovanni.cammarota@policlinicogemelli.it
- Contact Person Name
- Giovanni Cammarota
- Contact Person Email
- giovanni.cammarota@policlinicogemelli.it
Austria
- Earliest CTIS Part Ii Submission Date
- 18-12-2025
- Latest Decision Or Authorization Date
- 30-03-2026
- Processing Time Days
- 102
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Medical University Of Vienna
- Department Name
- Department of Medicine III, Division of gastroenterology & hepatology
- Principal Investigator Name
- Stefanie Dabsch
- Principal Investigator Email
- stefanie.dabsch@meduniwien.ac.at
- Contact Person Name
- Stefanie Dabsch
- Contact Person Email
- stefanie.dabsch@meduniwien.ac.at
Norway
- Earliest CTIS Part Ii Submission Date
- 08-12-2025
- Latest Decision Or Authorization Date
- 27-03-2026
- Processing Time Days
- 109
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Oslo University Hospital HF
- Department Name
- Department of Gastroenterology, Kirkeveien 166, Building 6, 3rd floor, Room 3004
- Principal Investigator Name
- Marte Lie Hoivik
- Principal Investigator Email
- moliho@ous-hf.no
- Contact Person Name
- Marte Lie Hoivik
- Contact Person Email
- moliho@ous-hf.no
Finland
- Earliest CTIS Part Ii Submission Date
- 16-12-2025
- Latest Decision Or Authorization Date
- 30-03-2026
- Processing Time Days
- 104
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- HUS-yhtymae
- Department Name
- Dept. of Gastroenterology
- Principal Investigator Name
- Sampsa Pikkarainen
- Principal Investigator Email
- sampsa.pikkarainen@hus.fi
- Contact Person Name
- Sampsa Pikkarainen
- Contact Person Email
- sampsa.pikkarainen@hus.fi
Belgium
- Earliest CTIS Part Ii Submission Date
- 05-12-2025
- Latest Decision Or Authorization Date
- 27-03-2026
- Processing Time Days
- 112
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- UZ Leuven
- Department Name
- Gastro-enterology
- Principal Investigator Name
- Tim Vanuytsel
- Principal Investigator Email
- tim.vanuytsel@uzleuven.be
- Contact Person Name
- Tim Vanuytsel
- Contact Person Email
- tim.vanuytsel@uzleuven.be
Hungary
- Earliest CTIS Part Ii Submission Date
- 18-12-2025
- Latest Decision Or Authorization Date
- 31-03-2026
- Processing Time Days
- 103
- Number Of Sites
- 3
- Number Of Participants
- 7
Sites
- Site Name
- Semmelweis University
- Department Name
- Sebészeti, Transzplantációs és Gasztroenterológiai Klinika
- Principal Investigator Name
- Katalin Müllner
- Principal Investigator Email
- mullner.katalin@gmail.com
- Contact Person Name
- Katalin Müllner
- Contact Person Email
- mullner.katalin@gmail.com
- Site Name
- Central Hospital Of Northern Pest Military Hospital
- Department Name
- Gasztroenterológia
- Principal Investigator Name
- Tibor Gyökeres
- Principal Investigator Email
- tiborgyokeres65@gmail.com
- Contact Person Name
- Tibor Gyökeres
- Contact Person Email
- tiborgyokeres65@gmail.com
- Site Name
- Del-Budai Centrumkorhaz Szent Imre Egyetemi Oktatokorhaz
- Department Name
- Gasztroenterológiai osztály
- Principal Investigator Name
- Gábor Udvarhelyi
- Principal Investigator Email
- dr.udvarhelyi.gabor@gmail.com
- Contact Person Name
- Gábor Udvarhelyi
- Contact Person Email
- dr.udvarhelyi.gabor@gmail.com
Germany
- Earliest CTIS Part Ii Submission Date
- 08-12-2025
- Latest Decision Or Authorization Date
- 27-03-2026
- Processing Time Days
- 109
- Number Of Sites
- 6
- Number Of Participants
- 14
Sites
- Site Name
- Universitaetsklinikum Bonn AöR
- Department Name
- Klinik und Poliklinik für Allgemein-, Viszeral-, Thorax- und Gefäßchirurgie
- Principal Investigator Name
- Gun-Soo Hong
- Principal Investigator Email
- gun-soo.hong@ukbonn.de
- Contact Person Name
- Gun-Soo Hong
- Contact Person Email
- gun-soo.hong@ukbonn.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Medizinische Klinik m.S. Hepatologie und Gastroenterologie CCM/CVK, Campus Charité Mitte
- Principal Investigator Name
- Elisabeth Blüthner
- Principal Investigator Email
- elisabeth.bluethner@charite.de
- Contact Person Name
- Elisabeth Blüthner
- Contact Person Email
- elisabeth.bluethner@charite.de
- Site Name
- Rostock University Medical Center
- Department Name
- Abt. für Gastroenterologie, Endokrinologie & Stoffwechselkrankheiten, Zentrum f. Innere Medizin
- Principal Investigator Name
- Georg Lamprecht
- Principal Investigator Email
- georg.lamprecht@med.uni-rostock.de
- Contact Person Name
- Georg Lamprecht
- Contact Person Email
- georg.lamprecht@med.uni-rostock.de
- Site Name
- Asklepios Klinik St George
- Principal Investigator Name
- Ulrich-Frank Pape
- Principal Investigator Email
- ul.pape@asklepios.com
- Contact Person Name
- Ulrich-Frank Pape
- Contact Person Email
- ul.pape@asklepios.com
- Site Name
- Universitaetsklinikum Aachen AöR
- Department Name
- Klinik für Allgemein-, Viszeral-, Kinder- und Transplantationschirurgie
- Principal Investigator Name
- Martin von Websky
- Principal Investigator Email
- mvonwebsky@ukaachen.de
- Contact Person Name
- Martin von Websky
- Contact Person Email
- mvonwebsky@ukaachen.de
- Site Name
- Eugastro GmbH
- Principal Investigator Name
- Ingolf Schiefke
- Principal Investigator Email
- ingolf.schiefke@eugastro.de
- Contact Person Name
- Ingolf Schiefke
- Contact Person Email
- ingolf.schiefke@eugastro.de
Spain
- Earliest CTIS Part Ii Submission Date
- 15-12-2025
- Latest Decision Or Authorization Date
- 28-04-2026
- Processing Time Days
- 134
- Number Of Sites
- 4
- Number Of Participants
- 6
Sites
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Endocrinology and nutrition
- Principal Investigator Name
- Maria Irene Maiz Jimenez
- Principal Investigator Email
- mariairene.maiz@salud.madrid.org
- Contact Person Name
- Maria Irene Maiz Jimenez
- Contact Person Email
- mariairene.maiz@salud.madrid.org
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Endocrinology and nutrition
- Principal Investigator Name
- Maria Cristina Cuerda Compes
- Principal Investigator Email
- mariacristina.cuerda@salud.madrid.org
- Contact Person Name
- Maria Cristina Cuerda Compes
- Contact Person Email
- mariacristina.cuerda@salud.madrid.org
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Endocrinology and nutrition
- Principal Investigator Name
- Pilar Serrano Aguayo
- Principal Investigator Email
- mariap.serrano.sspa@juntadeandalucia.es
- Contact Person Name
- Pilar Serrano Aguayo
- Contact Person Email
- mariap.serrano.sspa@juntadeandalucia.es
- Site Name
- Bellvitge University Hospital
- Department Name
- Endocrinology and nutrition
- Principal Investigator Name
- Rafael López-Urdiales
- Principal Investigator Email
- rafaellopez@bellvitgehospital.cat
- Contact Person Name
- Rafael López-Urdiales
- Contact Person Email
- rafaellopez@bellvitgehospital.cat
Sponsor
Primary sponsor
- Full Name
- Zealand Pharma A/S
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Denmark
Contract research organisations
- Name
- Pharmaceutical Product Development LLC (PPD)
- Responsibilities
- sponsorDuties codes: 4
- Name
- PPD Development LP
- Responsibilities
- sponsorDuties codes: 1,10,11,12,13,2,5,6,9
- Name
- PPD Global Central Labs
- Responsibilities
- sponsorDuties codes: 4
- Name
- Clinigma ApS
- Responsibilities
- sponsorDuties codes: 15 (qualitative interviews)
Third parties
- {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"sponsorDuties codes: 1,10,11,12,13,2,5,6,9","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Mayo Collaborative Services LLC","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"sponsorDuties codes: 15 (eCOA)","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
- {"country":"Denmark","full_name":"Clinigma ApS","duties_or_roles":"sponsorDuties codes: 15 (Perform the qualitative interviews per Protocol v4.0)","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Charles River Laboratories Edinburgh Limited","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"LABOR AUGSBURG MVZ GMBH","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Industry"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: 7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Netherlands","full_name":"4G Clinical B.V.","duties_or_roles":"sponsorDuties codes: 3","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Finland","full_name":"SYRINX Bioanalytics Oy","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Mlm Medical Labs GmbH","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Arup Laboratories Inc.","duties_or_roles":"sponsorDuties codes: 15 (Citrulline testing)","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"sponsorDuties codes: 15 (Patient travel and reimbursement)","organisation_type":"Non-Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Glepaglutide 20.0 mg/mL
- Active Substance
- GLEPAGLUTIDE
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS USE
- Route
- Subcutaneous
- Authorisation Status
- Investigational
- Starting Dose
- 10 mg
- Dose Levels
- 10 mg (fixed dose)
- Frequency
- Twice-weekly
- Maximum Dose
- 10 mg per administration (as listed)
- Investigational Product Name
- Placebo for glepaglutide
- Modality
- Other
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