Clinical trial • Phase III • Gastroenterology

GLEPAGLUTIDE for Short bowel syndrome

Phase III trial of GLEPAGLUTIDE for Short bowel syndrome. open-label. 19 participants.

Overview

Trial Therapeutic Area
Gastroenterology
Trial Disease
Short bowel syndrome
Trial Stage
Phase III
Drug Modality
Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
12-09-2025
First CTIS Authorization Date
26-11-2025

Trial design

open-label Phase III trial across 9 sites in Belgium, Germany, France and others.

Open Label
Yes
Target Sample Size
19
Trial Duration For Participant
728

Eligibility

Recruits 19 The trial record indicates isVulnerablePopulationSelected=true. Participants must provide signed informed consent (inclusion criterion: "Has provided signed informed consent and agrees to comply with protocol requirements"). Specific informed consent forms are provided for pregnant participants and pregnant partners. No assent procedures for minors are mentioned (trial population is described as adult patients)..

Pregnancy Exclusion
5. If female, is of childbearing potential, pregnant, breastfeeding, intends to become pregnant, or is not using contraceptive methods. Refer to Section 10.2.2 for the definition of contraception.
Vulnerable Population
The trial record indicates isVulnerablePopulationSelected=true. Participants must provide signed informed consent (inclusion criterion: "Has provided signed informed consent and agrees to comply with protocol requirements"). Specific informed consent forms are provided for pregnant participants and pregnant partners. No assent procedures for minors are mentioned (trial population is described as adult patients).

Inclusion criteria

  • {"criterion_text":"- 1. Has provided signed informed consent and agrees to comply with protocol requirements."}
  • {"criterion_text":"- 2. Is being a. Actively treated and has completed at least 6 months of glepaglutide treatment in the EASE SBS 2 trial, or b. Actively treated in the EASE SBS 3 trial."}

Exclusion criteria

  • {"criterion_text":"- 1. Has a condition, disease, or circumstance that, in the opinion of the investigator, would put the patient at any undue risk, prevent completion of the trial, or confound the planned assessments of the trial."}
  • {"criterion_text":"- 2. Use of GLP-1, GLP-2 (e.g., teduglutide), HGH, DPP-4 inhibitors, somatostatin, or analogs thereof. Note: Prior use of glepaglutide is allowed."}
  • {"criterion_text":"- 3. Had major protocol deviation(s) (as determined by the sponsor) in the EASE SBS 2 or EASE SBS 3 trial that would affect the conduct of the present trial."}
  • {"criterion_text":"- 4. Has permanently discontinued the trial treatment because of an AE, assessed as related to the trial drug in the EASE SBS 2 or EASE SBS 3 trial. (Note: AEs are treatment-emergent unless otherwise specified.)"}
  • {"criterion_text":"- 5. If female, is of childbearing potential, pregnant, breastfeeding, intends to become pregnant, or is not using contraceptive methods. Refer to Section 10.2.2 for the definition of contraception."}
  • {"criterion_text":"- 6. Has a known or suspected hypersensitivity to glepaglutide or related products."}
  • {"criterion_text":"- 7. Has committed to an institution by virtue of an order issued by the judicial or administrative authorities."}
  • {"criterion_text":"- 8. Is an employee of the sponsor or investigator or otherwise dependent on them."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- TEAEs from baseline (Visit 1) to the safety follow-up visit","definition_or_measurement_approach":"Treatment-emergent adverse events (TEAEs) recorded from baseline (Visit 1) until the safety follow-up visit."}

Secondary endpoints

  • {"endpoint_text":"- Change in prescribed weekly PS volume from baseline to Month 24/EOT","definition_or_measurement_approach":"Change in prescribed weekly parenteral support (PS) volume measured from baseline to Month 24 or end of treatment (EOT)."}

Recruitment

Planned Sample Size
19
Recruitment Window Months
36
Consent Approach
Signed informed consent is required from participants (adults). Multiple language informed consent forms are provided (examples in English, French, Dutch, German, Polish as per published ICF documents). Specific ICFs exist for pregnancy and pregnant partner situations. No assent procedures or minor-consent processes are described in the record.

Geography

Total Number Of Sites
9
Total Number Of Participants
19

Belgium

Earliest CTIS Part Ii Submission Date
25-11-2025
Latest Decision Or Authorization Date
15-12-2025
Processing Time Days
20
Number Of Sites
1
Number Of Participants
1

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

Germany

Earliest CTIS Part Ii Submission Date
09-11-2025
Latest Decision Or Authorization Date
26-11-2025
Processing Time Days
17
Number Of Sites
4
Number Of Participants
9

Sites

Site Name
Asklepios Klinik St George
Department Name
Innere Medizin und Gastroenterologie
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
Charite Universitaetsmedizin Berlin KöR
Department Name
Medizinische Klinik m.S. Hepatologie und Gastroenterologie CCM/CVK
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
Goethe University Frankfurt
Department Name
Medizinische Klinik 1
Principal Investigator Name
Irina Blumenstein
Principal Investigator Email
blumenstein@em.uni-frankfurt.de
Contact Person Name
Irina Blumenstein
Site Name
Rostock University Medical Center
Department Name
Zentrum für Innere Medizin Klinik II - Abteilung für Gastroenterologie
Principal Investigator Name
Georg Lamprecht
Principal Investigator Email
georg.lamprecht@med.uni-rostock.de
Contact Person Name
Georg Lamprecht

France

Earliest CTIS Part Ii Submission Date
14-11-2025
Latest Decision Or Authorization Date
15-12-2025
Processing Time Days
31
Number Of Sites
1
Number Of Participants
1

Sites

Site Name
Assistance Publique Hopitaux De Paris
Department Name
Department of Gastroenterology, IBD and Nutrition Hospital Beaujon – AP-HP
Principal Investigator Name
Francisca Joly
Principal Investigator Email
francisca.joly@aphp.fr
Contact Person Name
Francisca Joly
Contact Person Email
francisca.joly@aphp.fr

Poland

Earliest CTIS Part Ii Submission Date
07-11-2025
Latest Decision Or Authorization Date
04-01-2026
Processing Time Days
58
Number Of Sites
3
Number Of Participants
8

Sites

Site Name
Samodzielny Publiczny Szpital Kliniczny Im. Prof. W. Orlowskiego CMKP
Department Name
Oddział Kliniczny Żywienia i Chirurgii
Principal Investigator Name
Jacek Sobocki
Principal Investigator Email
jsobocki@mp.pl
Contact Person Name
Jacek Sobocki
Contact Person Email
jsobocki@mp.pl
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
Szpital Skawina Sp. z o.o.
Department Name
Oddział Chirurgii Ogólnej i Leczenia Niewydolności Przewodu Pokarmowego
Principal Investigator Name
Stanisław Kłęk
Principal Investigator Email
stanislaw.klek@szpitalskawina.pl
Contact Person Name
Stanisław Kłęk

Sponsor

Primary sponsor

Full Name
Zealand Pharma A/S
Organisation Type
Pharmaceutical company
Country Of Registered Address
Denmark

Contract research organisations

Name
4G Clinical B.V.
Responsibilities
3
Name
PPD Development LP
Responsibilities
1,10,11,12,13,2,5,6,9

Third parties

  • {"country":"Germany","full_name":"Catalent Germany Schorndorf GmbH","duties_or_roles":"IMP packaging","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient travel and reimbursement","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
  • {"country":"Finland","full_name":"SYRINX Bioanalytics Oy","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
  • {"country":"Netherlands","full_name":"4G Clinical B.V.","duties_or_roles":"3","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"The Doctors Laboratory Limited","duties_or_roles":"4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Germany","full_name":"Mlm Medical Labs GmbH","duties_or_roles":"4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Germany","full_name":"LABOR AUGSBURG MVZ GMBH","duties_or_roles":"4","organisation_type":"Industry"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Charles River Laboratories Edinburgh Limited","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"1,10,11,12,13,2,5,6,9","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Glepaglutide 20.0 mg/mL
Active Substance
GLEPAGLUTIDE
Modality
Peptide/protein/enzyme
Routes Of Administration
Subcutaneous
Route
Subcutaneous
Starting Dose
10 mg twice weekly
Dose Levels
10 mg
Frequency
Twice weekly
Maximum Dose
10 mg

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