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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07197944
- Acronym / sponsor ID
- EASE SBS 5 / ZP1848-23029
- Conditions
- Short Bowel Syndrome
- Keywords
- Intestinal Failure, Pathologic Processes, Malabsorption Syndromes, Intestinal Diseases, Gastrointestinal Diseases, Digestive System Diseases, Postoperative Complications, Short Bowel Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Zealand PharmaIndustry (pharma, biotech, devices)
- Study start
- 11 Feb 2026 (actual)
- Primary completion
- 23 Oct 2028 (estimated)
- Study completion
- 28 Feb 2032 (estimated)
- First posted
- 30 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Glepaglutide Group | Experimental | Drug: Glepaglutide |
| Placebo Group | Placebo comparator | Other: PlaceboPlacebo for glepaglutide |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlepaglutideAlso: ZP1848Subcutaneous (SC) injections twice weekly | Drug | Glepaglutide Group |
| PlaceboSC injections twice weekly | Other | Placebo Group |
Primary outcome
Change in weekly Parenteral Support (PS) volume
Time frame: Baseline to Week 24
10 secondary outcomes
Proportion of participants achieving clinical response
Time frame: Baseline to Week 52
Proportion of participants achieving clinical response
Time frame: Baseline to Week 20 and Week 24
Proportion of participants with a reduction in days on PS ≥1 day/week
Time frame: Baseline to Week 52
Proportion of participants with a reduction in days on PS ≥1 day/week
Time frame: Baseline to Week 24
Proportion of participants with a reduction of 100% weekly PS volume (weaned-off)
Time frame: Baseline to Week 52
Proportion of participants with a reduction of 100% weekly PS volume (weaned-off)
Time frame: Baseline to Week 24
Proportion of participants achieving 'much better' Patient Global Impression of Change (PGIC) status
Time frame: Week 24
Change in weekly PS volume
Time frame: Baseline to Week 12
Change in weekly PS volume
Time frame: Baseline to Week 8
Incidence of Treatment Emergent Adverse Events (TEAEs)
Time frame: Baseline to Week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The University of Chicago Medicine
Chicago, United States
Washington University Center for Advanced Medicine
St Louis, United States
33 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Glepaglutide in people with Short Bowel Syndrome, run by Zealand Pharma at 33 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, Germany, Hungary, Italy, Poland and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weekly Parenteral Support (PS) volume (time frame: Baseline to Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.