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New drug shows promise for managing short bowel syndrome Long-Term

NCT ID NCT07228403

Disease control Sponsor: Zealand Pharma Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 2 times

Summary

This study looks at the long-term safety and effectiveness of a drug called glepaglutide in adults with short bowel syndrome (SBS), a condition where the body can't absorb enough nutrients from food. Participants who were already in earlier trials can continue treatment for up to 2 years. The goal is to see if the drug helps reduce the need for intravenous nutrition support and is safe over time.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

28 people

The number who actually took part.

Started

Dec 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Has provided signed informed consent and agrees to comply with protocol requirements. * Is being 1. Actively treated and has completed at least 6 months of glepaglutide treatment in the EASE SBS 2 trial, or 2. Actively treated in the EASE SBS 3 trial. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

Digestive System Diseases digestive system disorder intestinal disorder malabsorption syndrome Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications short bowel syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Short bowel syndrome (SBS)

Contacts and locations

Locations

  • AP-HP - Hôpital Beaujon

    Clichy, Hauts-de-Seine, 92118, France

  • Asklepios Klinik St. Georg

    Hamburg, 20099, Germany

  • Charité - Universitätsmedizin Berlin

    Berlin, State of Berlin, 10117, Germany

  • Cleveland Clinic-9500 Euclid Ave

    Cleveland, Ohio, 44195-0001, United States

  • LHSC - University Hospital

    London, Ontario, N6A 4V2, Canada

  • Lied Transplant Center at Nebraska Medical Center

    Omaha, Nebraska, 68105, United States

  • Mayo Clinic - PPDS

    Rochester, Minnesota, 55905-0001, United States

  • Samodzielny Publiczny Szpitala Kliniczny im. Prof. Witolda Orlowskiego CMKP

    Warsaw, Masovian Voivodeship, 00-416, Poland

  • St Mark's Hospital (Central Middlesex Hospital)

    Ealing, NW10 7NS, United Kingdom

  • Szpital Skawina sp. z o.o. im. Stanley Dudricka

    Skawina, Lesser Poland Voivodeship, 32-050, Poland

  • UZ Leuven - PPDS

    Leuven, 3000, Belgium

  • Universitätsklinikum Bonn

    Bonn, North Rhine-Westphalia, 53127, Germany

  • Universitätsklinikum Frankfurt

    Frankfurt am Main, Hesse, 60590, Germany

  • Universitätsmedizin Rostock

    Rostock, Mecklenburg-Vorpommern, 18057, Germany

  • Vanderbilt University Medical Center-Tennesse-1211 21st Ave S

    Nashville, Tennessee, 37212-2700, United States

  • Wojewódzki Szpital Specjalistycznyo im. M. Pirogowa w Lodzi

    Lodz, 90-531, Poland

More trials for these conditions

Other studies related to the condition(s) this trial covers.