Short Bowel Syndrome (SBS)Phase 3EASE SBS 6NCT07228403
Efficacy and Safety Evaluation of Glepaglutide in Treatment of Short Bowel Syndrome
A Phase 3 study testing Glepaglutide 10 mg in people with Short Bowel Syndrome (SBS), run by Zealand Pharma at 16 sites in 7 countries.
Trial summary
The purpose of this study is to understand the safety and efficacy of twice weekly glepaglutide 10 mg in adult patients with short bowel syndrome (SBS), who were previously enrolled in the EASE SBS 2 or EASE SBS 3 trials. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Short Bowel Syndrome (SBS)
- What is being tested?
- Glepaglutide 10 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 16 sitesin 7 countries
- Study dates
- 11 Dec 2025to 31 Dec 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has provided signed informed consent and agrees to comply with protocol requirements.
- Is being
- Actively treated and has completed at least 6 months of glepaglutide treatment in the EASE SBS 2 trial, or
- Actively treated in the EASE SBS 3 trial.
Who cannot join
- 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.
- Use of GLP-1, GLP-2 (e.g., teduglutide), HGH, DPP-4 inhibitors, somatostatin, or analogs thereof. Note: Prior use of glepaglutide is allowed.
- 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.
- 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.)
- 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.
- Has a known or suspected hypersensitivity to glepaglutide or related products.
- Has committed to an institution by virtue of an order issued by the judicial or administrative authorities.
- Is an employee of the sponsor or investigator or otherwise dependent on them.
Trial locations and contacts
16 sites in 7 countries.
16 sites in 7 countries
Germany5 sites
Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, 10117
Universitätsklinikum Bonn
Bonn, North Rhine-Westphalia, 53127
Universitätsklinikum Frankfurt
Frankfurt am Main, Hesse, 60590
Asklepios Klinik St. Georg
Hamburg, 20099
Universitätsmedizin Rostock
Rostock, Mecklenburg-Vorpommern, 18057
United States4 sites
Cleveland Clinic-9500 Euclid Ave
Cleveland, Ohio, 44195-0001
Vanderbilt University Medical Center-Tennesse-1211 21st Ave S
Nashville, Tennessee, 37212-2700
Lied Transplant Center at Nebraska Medical Center
Omaha, Nebraska, 68105
Mayo Clinic - PPDS
Rochester, Minnesota, 55905-0001
Poland3 sites
Wojewódzki Szpital Specjalistycznyo im. M. Pirogowa w Lodzi
Lodz, 90-531
Szpital Skawina sp. z o.o. im. Stanley Dudricka
Skawina, Lesser Poland Voivodeship, 32-050
Samodzielny Publiczny Szpitala Kliniczny im. Prof. Witolda Orlowskiego CMKP
Warsaw, Masovian Voivodeship, 00-416
United Kingdom1 site
St Mark's Hospital (Central Middlesex Hospital)
Ealing, NW10 7NS
About this study
Official title: A 104-week, Multicenter, Open-label, Single-arm, Phase 3 Extension Trial Investigating the Long-term Safety and Efficacy of Glepaglutide in Adult Patients With Short Bowel Syndrome (SBS) Rolling Over From the EASE SBS 2 or 3 Trials
The purpose of this study is to understand the safety and efficacy of twice weekly glepaglutide 10 mg in adult patients with short bowel syndrome (SBS), who were previously enrolled in the EASE SBS 2 or EASE SBS 3 trials. Participants currently on these trials will be able to continue their glepaglutide treatment by enrolling in this EASE SBS 6 extension trial. The trial includes a 24-month treatment period, followed by a 4-week safety follow-up period. Participants will attend trial visits, where they may undergo heart tests (electrocardiogram (ECG)), vital sign checks, colonoscopies, blood and urine tests, and physical exams.
Read the detailed description
This trial is a 104-week, multicenter, open-label, single-arm, phase 3 extension trial investigating the long-term safety and efficacy of glepaglutide in adult patients with short bowel syndrome (SBS) rolling over from the EASE SBS 2 or 3 trials.
- Conditions
- Short Bowel Syndrome (SBS)
- Being tested
- Glepaglutide 10 mg
- Keywords
- Malabsorption Syndromes, Intestinal Diseases, Gastrointestinal Diseases, Digestive System Diseases, Postoperative Complications, Pathologic Processes, Pathological Conditions, Signs and Symptoms, Short Bowel Syndrome
- Medical subject headings
- Short Bowel Syndrome, Malabsorption Syndromes, Intestinal Diseases, Gastrointestinal Diseases, Digestive System Diseases, Postoperative Complications, Pathologic Processes, Pathological Conditions, Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glepaglutide 10 mgDrug
Also called ZP1848
Administered twice weekly by subcutaneous injection for a maximum of 24 months
| Study group | Role | What they receive |
|---|---|---|
| Open-label Glepaglutide | Experimental | Not described Receives: Drug: Glepaglutide 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment emergent adverse events (TEAEs)
Measured: From baseline to the safety follow-up visit (A maximum of 25 months)
Secondary outcomes (1)
Change in prescribed weekly parenteral support (PS) volume
Measured: From baseline to Month 24 (End of Trial)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2025
- Study start11 Dec 2025
- Primary completion18 Sep 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Short Bowel Syndrome (SBS)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07228403
- Sponsor's protocol ID
- ZP1848-25009
- Other IDs
- 2025-520775-81-00, U1111-1317-8307, 2025
- Acronym
- EASE SBS 6
- Status last verified
- Jul 2026
- First submitted
- 13 Nov 2025
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- 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 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 104-week, Multicenter, Open-label, Single-arm, Phase 3 Extension Trial Investigating the Long-term Safety and Efficacy of Glepaglutide in Adult Patients With Short Bowel Syndrome (SBS) Rolling Over From the EASE SBS 2 or 3 Trials
- ClinicalTrials.gov ID
- NCT07228403
- Acronym / sponsor ID
- EASE SBS 6 / ZP1848-25009
- Conditions
- Short Bowel Syndrome (SBS)
- Keywords
- Malabsorption Syndromes, Intestinal Diseases, Gastrointestinal Diseases, Digestive System Diseases, Postoperative Complications, Pathologic Processes, Pathological Conditions, Signs and Symptoms, Short Bowel Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Zealand PharmaIndustry (pharma, biotech, devices)
- Study start
- 11 Dec 2025 (actual)
- Primary completion
- 18 Sep 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 14 Nov 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 this study is to understand the safety and efficacy of twice weekly glepaglutide 10 mg in adult patients with short bowel syndrome (SBS), who were previously enrolled in the EASE SBS 2 or EASE SBS 3 trials. Participants currently on these trials will be able to continue their glepaglutide treatment by enrolling in this EASE SBS 6 extension trial. The trial includes a 24-month treatment period, followed by a 4-week safety follow-up period. Participants will attend trial visits, where they may undergo heart tests (electrocardiogram (ECG)), vital sign checks, colonoscopies, blood and urine tests, and physical exams.
Detailed description
This trial is a 104-week, multicenter, open-label, single-arm, phase 3 extension trial investigating the long-term safety and efficacy of glepaglutide in adult patients with short bowel syndrome (SBS) rolling over from the EASE SBS 2 or 3 trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-label Glepaglutide | Experimental | Drug: Glepaglutide 10 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Has provided signed informed consent and agrees to comply with protocol requirements.
- Is being
Key exclusion criteria (8 listed)
- 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.
- Use of GLP-1, GLP-2 (e.g., teduglutide), HGH, DPP-4 inhibitors, somatostatin, or analogs thereof. Note: Prior use of glepaglutide is allowed.
- 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.
- 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.)
- 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.
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 |
|---|---|---|
| Glepaglutide 10 mgAlso: ZP1848Administered twice weekly by subcutaneous injection for a maximum of 24 months | Drug | Open-label Glepaglutide |
Primary outcome
Number of treatment emergent adverse events (TEAEs)
Time frame: From baseline to the safety follow-up visit (A maximum of 25 months)
1 secondary outcome
Change in prescribed weekly parenteral support (PS) volume
Time frame: From baseline to Month 24 (End of Trial)
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 30 Jul 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Glepaglutide 10 mg in people with Short Bowel Syndrome (SBS), run by Zealand Pharma at 16 sites in 7 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 4 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Germany, United States, Poland, Belgium, Canada and 2 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of treatment emergent adverse events (TEAEs) (time frame: From baseline to the safety follow-up visit (A maximum of 25 months)). 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 30 Jul 2026.