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New drug could help people with short bowel syndrome ditch IV nutrition

NCT ID NCT03905707

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Sep 09, 2026 · Updated 3 times

Summary

This phase 3 trial tests the long-term safety of glepaglutide, a drug that mimics a natural gut hormone, in 145 adults with short bowel syndrome. The goal is to see if it can safely help the gut absorb more nutrients, potentially reducing the need for intravenous feeding. Participants must have completed a prior glepaglutide study.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
glepaglutide (a lab-made protein similar to GLP-2, which helps the gut absorb nutrients)
What this could lead to
If it works, this could reduce or eliminate the need for intravenous nutrition in people with short bowel syndrome, improving their quality of life.
What could go wrong
This is an extension trial focused on safety, not proof of effectiveness. The drug may cause side effects or not work for everyone. Results may not apply to all patients.

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

150 people

The number who actually took part.

Started

May 2019

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 lead-in trial (ZP1848-17111) or completed the Phase 2 trial (ZP1848-15073) Exclusion Criteria: * Withdrawal of consent from the lead-in trial * Any condition or disease or circumstance that in the Investigator's opinion would put the patient at any undue risk, prevent completion of the trial, or interfere with the analysis of the trial results * Use of GLP-1, GLP-2, human growth hormone, somatostatin, or analogs thereof, within 3 months prior to Screening * 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

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Georgetown University Medical Center

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

  • Hôpital Beaujon

    Clichy, France

  • Mayo Clinic College of Medicine

    Rochester, Minnesota, 55905, United States

  • Mount Sinai Hospital

    New York, New York, 10029, United States

  • Rigshospitalet

    Copenhagen, Denmark

  • Solumed

    Poznan, Poland

  • St Mark's Hospital

    Harrow, United Kingdom

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

    Skawina, Poland

  • The Royal Alexandra Hospital

    Edmonton, Canada

  • UCLH Foundation NHS Trust

    London, United Kingdom

  • UMC Radboud Nijmegen

    Nijmegen, Netherlands

  • UZ Leuven

    Leuven, Belgium

  • University Health Network - Toronto General Hospital

    Toronto, Canada

  • University Hospital Southampton NHS Foundation Trust

    Southampton, United Kingdom

  • University of Chicago Children's Hospital

    Chicago, Illinois, 60637, United States

  • University of East Anglia

    Norwich, United Kingdom

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198-3285, United States

  • Universitätsklinikum Bonn

    Bonn, 53127, Germany

  • Universitätsklinikum Frankfurt - Med. Klinik I

    Frankfurt, Germany

  • Universitätsmedizin Rostock

    Rostock, Germany

  • Vanderbilt University Medical Center, Nashville

    Nashville, Tennessee, 68198-3285, United States

  • Western University

    London, N6A 4V2, Canada

  • 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.