Short Bowel SyndromePhase 3EASE SBS 5NCT07197944
Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS
A Phase 3 study testing Glepaglutide in people with Short Bowel Syndrome, run by Zealand Pharma at 33 sites in 14 countries.
Trial summary
The purpose of the present Phase 3 trial is to confirm the efficacy and safety of glepaglutide 10 mg twice weekly in a patient population with SBS-IF and generate additional long-term safety data. Glepaglutide is the International Nonproprietary Name and United States Adopted Name (USAN) for ZP1848. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Short Bowel Syndrome
- What is being tested?
- Glepaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 33 sitesin 14 countries
- Study dates
- 11 Feb 2026to 28 Feb 2032
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent;
- Age of 18 to 90 years;
- A 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);
- Stable PS need of ≥3 days per week;
- No restorative surgery planned during the trial period;
- Having a stoma or colon in continuity.
Who cannot join
- More than 2 SBS- or PS-related hospitalizations within 6 months before screening;
- Poorly controlled Inflammatory Bowel Disease (IBD) that is moderately or severely active or a fistula that can interfere with the measurements or examinations required in the trial;
- 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;
- BMI <18.5 kg/m^2.
Trial locations and contacts
33 sites in 14 countries. Contact the study team or a site near you to ask about taking part.
33 sites in 14 countries
United States6 sites, 6 recruiting
- Recruiting
The University of Chicago Medicine
Chicago, Illinois, 60637-1443
Carol Semrad, 773-702-6921, csemrad@medicine.bsd.uchicago.edu
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Dawn Adams, (615) 322-0128, dawn.w.adams@vanderbilt.edu
- Not yet recruiting
New York Presbyterian Hospital-Columbia University Medical Center
New York, New York, 10032
Sivan Kinberg, MD, 212-305-5903, sk1312@cumc.columbia.edu
- Recruiting
Lied Transplant Center at Nebraska Medical Center
Omaha, Nebraska, 68105
David Mercer, 402-559-2556, dmercer@unmc.edu
- Recruiting
UPMC Starzl Transplantation Institute
Pittsburgh, Pennsylvania, 15213
Ruy Cruz, MD, 412-647-0320, cruzrj2@upmc.edu
- Recruiting
Washington University Center for Advanced Medicine
St Louis, Missouri, 63110
Matthew Ciorba, MD, 314-273-4543, mciorba@wustl.edu
Germany6 sites, 6 recruiting
- Recruiting
Universitätsklinikum Aachen
Aachen, 52074
Martin Von Websky, 4922828715777, kurzdarm@ukbonn.de
- Recruiting
Charité - Universitätsmedizin Berlin
Berlin, 10117
Elisabeth Blüthner, 4930450553022, elisabeth.bluethner@charite.de
- Recruiting
Universitätsklinikum Bonn
Bonn, 53127
Gun-Soo Hong, MD, 4922828715857, gun-soo.hong@ukbonn.de
- Recruiting
Asklepios Klinik St. Georg
Hamburg
Ulrich-Frank Pape, (494) 017-8861, ul.pape@asklepios.com
- Recruiting
Eugastro Klinische Studien GmbH
Leipzig, Saxony, 4103
Ingolf Schiefke, MD, 493414935720, ingolf.schiefke@eugastro.de
- Recruiting
Universitätsmedizin Rostock
Rostock, Mecklenburg-Vorpommern, 18057
Georg Lamprecht, 493814947481, georg.lamprecht@med.uni-rostock.de
Hungary3 sites, 3 recruiting
- Recruiting
Eszak-Pesti Centrumkorhaz -Honvedkorhaz- Podmaniczky utcai telephely
Budapest, 1062
Tibor Gyökeres, (361) 302-0841, gyokereshonvedstudy@gmail.com
- Recruiting
Semmelweis Egyetem - Sebészeti, Transzplantációs és Gasztroenterológiai Klinika
Budapest, 1082
Katalin Müllner, 36208250688, mullner.katalin@gmail.com
- Recruiting
Dél-budai Centrumkórház Szent Imre Egyetemi Oktatókórház
Budapest, 1115
Gabor Udvarhelyi, +36 (06) 1-464-8600, udvarhelyi.study@gmail.com
Italy3 sites, 3 recruiting
- Recruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, 20122
Luca Elli, 390255033418, luca.elli@policlinico.mi.it
- Recruiting
Azienda Ospedale - Università Padova
Padova, 35128
Brigida Barberio, 390498218718, brigida.barberio@unipd.it
- Recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS - PPDS
Rome, Lazio, 00136
Giovanni Cammarota, 390630000000, giovanni.cammarota@unicatt.it
Poland3 sites, 3 recruiting
- Recruiting
Wojewodzki Specjalistyczny Szpital im. M. Pirogowa w Lodzi
Lodz, Lódzkie, 90-531
Marek Kunecki, 501 712 166, marek.kunecki@vp.pl
- Recruiting
Szpital Skawina sp. z o.o. im. Stanley Dudricka
Skawina, 32-050
Stanislaw Klek, MD, 0048 12 444 65 26, klek@poczta.onet.pl
- Recruiting
Samodzielny Publiczny Szpitala Kliniczny im. Prof. Witolda Orlowskiego Centrum Medycznego Kształcenia Podyplomowego
Warsaw, 00-416
Jacek Sobocki, +48501796166, jsobocki@mp.pl
Spain3 sites, 3 recruiting
- Recruiting
Hospital General Universitario Gregorio Marañon
Madrid, Madrid, 28007
Maria Cristina Cuerda Compes, 34917996029, mcuerda.hgugm@salud.madrid.org
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, Madrid, 28041
Maria Irene Maiz Jimenez, MD, 34913908000, mariairene.maiz@salud.madrid.org
- Recruiting
Hospital Universitario Virgen del Rocio - PPDS
Seville, Sevilla, 41013
Pilar Serrano Aguayo, 34955012026, mariap.serrano.sspa@juntadeandalucia.es
Sweden2 sites, 2 recruiting
- Recruiting
Sahlgrenska Universitets sjukhuset
Gothenburg, 413 46
Jonas Varkey, MD, 46313428416, jonas.varkey@vgregion.se
- Recruiting
Karolinska Universitetssjukhuset Solna
Solna, 171 64
Stephan Haas, 08-123 800 00, stephan.haas@regionstockholm.se
Austria1 site, 1 recruiting
- Recruiting
Universitätsklinikum AKH Wien
Vienna, State of Vienna, 1090
Stefanie Dabsch, 4314040062450, stefanie.dabsch@meduniwien.ac.at
Belgium1 site, 1 recruiting
- Recruiting
Universitair Ziekenhuis (UZ) Leuven
Leuven, 3000
Tim Van Uytsel, (321) 633-2211, mailto:tim.vanuytsel@uzleuven.be
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet-Blegdamsvej 9
Copenhagen, 2100
Palle Bekker Jeppsen, MD, 4535452452, palle.bekker.jeppesen@regionh.dk
Finland1 site, 1 recruiting
- Recruiting
Helsingin Yliopistollinen Keskussairaala
Helsinki, 00290
Sampsa Pikkarainen, 358306000, sampsa.pikkarainen@hus.fi
France1 site, 1 recruiting
- Recruiting
AP-HP - Hôpital Beaujon
Clichy, 92118
Francisca Joly-Gomez, 330140875000, francisca.joly@aphp.fr
Netherlands1 site, 1 recruiting
- Recruiting
Radboud Universitair Medisch Centrum
Nijmegen, Gelderland, 6525 GA
Geert Wanten, MD, 31243611111, geert.wanten@radboudumc.nl
Norway1 site, 1 recruiting
- Recruiting
Oslo Universitetssykehus HF, Ullevål
Oslo, 0450
Marte L Hoivik, (479) 243-7392, moliho@ous-hf.no
About this study
Official title: A Phase 3, Double-blind, Randomized, Parallel Group, Placebo-controlled, Multicenter Trial to Confirm the Efficacy and Safety of Glepaglutide 10 mg Twice Weekly, Followed by a Long-term, Open-label Safety Evaluation in Patients With Short Bowel Syndrome-intestinal Failure (SBS-IF)
The purpose of the present Phase 3 trial is to confirm the efficacy and safety of glepaglutide 10 mg twice weekly in a patient population with SBS-IF and generate additional long-term safety data.
Glepaglutide is the International Nonproprietary Name and United States Adopted Name (USAN) for ZP1848.
Read the detailed description
The trial is a phase 3, double-blind, randomized, parallel-group, placebo-controlled, multicenter trial to confirm the efficacy and safety of glepaglutide 10 mg twice weekly, followed by a long-term, open-label safety evaluation in patients with short bowel syndrome-intestinal failure (SBS-IF).
- Conditions
- Short Bowel Syndrome
- Being tested
- Glepaglutide, Placebo
- Keywords
- Intestinal Failure, Pathologic Processes, Malabsorption Syndromes, Intestinal Diseases, Gastrointestinal Diseases, Digestive System Diseases, Postoperative Complications, Short Bowel Syndrome, Syndrome
- Medical subject headings
- Short Bowel Syndrome, Intestinal Failure, Pathologic Processes, Malabsorption Syndromes, Intestinal Diseases, Gastrointestinal Diseases, Digestive System Diseases, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlepaglutideDrug
Also called ZP1848
Subcutaneous (SC) injections twice weekly
PlaceboOther
SC injections twice weekly
| Study group | Role | What they receive |
|---|---|---|
| Glepaglutide Group | Experimental | Not described Receives: Drug: Glepaglutide |
| Placebo Group | Placebo comparator | Placebo for glepaglutide Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weekly Parenteral Support (PS) volume
Measured: Baseline to Week 24
Secondary outcomes (10)
Proportion of participants achieving clinical response
Defined as achieving a reduction of at least 20% in weekly PS volume
Measured: Baseline to Week 52
Proportion of participants achieving clinical response
Defined as achieving a reduction of at least 20% in weekly PS volume
Measured: Baseline to Week 20 and Week 24
Proportion of participants with a reduction in days on PS ≥1 day/week
Measured: Baseline to Week 52
Proportion of participants with a reduction in days on PS ≥1 day/week
Measured: Baseline to Week 24
Proportion of participants with a reduction of 100% weekly PS volume (weaned-off)
Measured: Baseline to Week 52
Proportion of participants with a reduction of 100% weekly PS volume (weaned-off)
Measured: Baseline to Week 24
Proportion of participants achieving 'much better' Patient Global Impression of Change (PGIC) status
PGIC scoring categories are: 'Much better', 'A little better', 'No change', 'A little worse', and 'Much worse'
Measured: Week 24
Change in weekly PS volume
Measured: Baseline to Week 12
Change in weekly PS volume
Measured: Baseline to Week 8
Incidence of Treatment Emergent Adverse Events (TEAEs)
Measured: Baseline to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start11 Feb 2026
- Primary completion23 Oct 2028 (estimated)
- Study completion28 Feb 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Short Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to one of two groups (arms) in parallel: one group receives glepaglutide, and the other group receives a placebo. After this initial phase, both groups receive open-label treatment with glepaglutide.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07197944
- Sponsor's protocol ID
- ZP1848-23029
- Other IDs
- 2024-512486-14-00, U1111-1302-6092
- Acronym
- EASE SBS 5
- Status last verified
- Sep 2026
- First submitted
- 26 Sep 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No