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New weekly shot shows promise for gut disorder patients

NCT ID NCT04881825

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 09, 2026 · Updated 2 times

Summary

This study tests the long-term safety and effectiveness of a weekly injection called glepaglutide in adults with short bowel syndrome, a condition where the body cannot absorb nutrients properly. Participants who completed a previous trial will receive the drug for about 2 years. The goal is to see if the treatment remains safe and continues to help manage the condition.

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

84 people

The number who actually took part.

Started

Jun 2021

Finished

Apr 2026

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 to 90 years

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: * Informed consent obtained before any trial-related activity * Completed the full treatment period of the extension trial EASE SBS 2 (ZP1848-17127) Exclusion Criteria: * Any condition, disease, or circumstance that in the Investigator's opinion would put the patient at any undue risk, prevent completion of the trial, or confound the planned assessments of the trial * Not having a colonoscopy performed at End of Trial in EASE SBS 2 (for patients with remnant colon). Note. The results of the colonoscopy must not give rise to any safety concerns. A colonoscopy performed within 6 months prior to End of Trial and not giving rise to any safety concerns is accepted. For patients with a remnant colon, which is not connected to the passage of foods and is thereby dormant, a computerized tomography (CT) scan or magnetic resonance imaging (MRI) will suffice at the discretion of the Investigator * Use of GLP-1, GLP-2, human growth hormone (HGH), dipeptidyl peptidase-4 (DPP-4) inhibitors, somatostatin, or analogs thereof within 3 months. Note: Prior use of glepaglutide trial drug is allowed * Females of childbearing potential, who are pregnant, breast-feeding, intend to become pregnant, or are not using highly effective contraceptive methods

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Conditions

The condition(s) this trial relates to.

short bowel syndrome

As listed by the trial registrant

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

Short bowel syndrome

Contacts and locations

Locations

  • Asklepios Kliniken Hamburg GmbH

    Hamburg, Germany

  • Centre Hospitalier Lyon-Sud

    Pierre-Bénite, France

  • Charité - Universitätsmedizin Berlin

    Berlin, Germany

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007, United States

  • Hôpital Beaujon

    Clichy, France

  • Mayo Clinic College of Medicin

    Rochester, Minnesota, 55905, United States

  • Norfolk and Norwich University Hospitals

    Norwich, United Kingdom

  • Rigshospitalet

    Copenhagen, Denmark

  • St Mark's Hospital

    Harrow, United Kingdom

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

    Skawina, Poland

  • UCLH Foundation NHS Trust

    London, United Kingdom

  • UMC Radboud Nijmegen

    Nijmegen, Netherlands

  • Universitair Ziekenhuis Leuven

    Leuven, Belgium

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

  • Universitätsklinikum Bonn

    Bonn, 53127, Germany

  • Universitätsklinikum Frankfurt

    Frankfurt, Germany

  • Universitätsmedizin Rostock

    Rostock, Germany

  • Vanderbilt University Medical Center, Nashville

    Nashville, Tennessee, 68198-3285, United States

  • Wojewodzki Specjalistyczny Szpital im. M. Pirogowa w Lodzi

    Lodz, Poland

More trials for these conditions

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