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Could a weekly shot free short bowel patients from IV bags?

NCT ID NCT07197944

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 13, 2026 · Updated 2 times

Summary

This phase 3 trial tests glepaglutide, a synthetic hormone given as a twice-weekly injection, in 90 adults with short bowel syndrome who rely on IV nutrition. The goal is to see if the drug can safely reduce the amount of IV support needed. Participants will be randomly assigned to receive the drug or a placebo for several weeks, followed by an open-label period where everyone gets the drug.

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 synthetic hormone injection)
What this could lead to
If successful, this could reduce or eliminate the need for daily IV nutrition in people with short bowel syndrome, improving quality of life.
What could go wrong
This is a phase 3 trial, but it's still experimental. The drug may not work for everyone, and side effects like injection site reactions or gastrointestinal issues are possible.

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

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Feb 2032

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 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.

Key Inclusion Criteria: * 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. Key Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

Digestive System Diseases digestive system disorder intestinal disorder Intestinal Failure malabsorption syndrome Pathologic Processes Postoperative Complications short bowel syndrome syndromic disease

As listed by the trial registrant

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

Short bowel syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    31 sites in 14 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AP-HP - Hôpital Beaujon

    RECRUITING

    Clichy, 92118, France

  • Asklepios Klinik St. Georg

    RECRUITING

    Hamburg, Germany

  • Azienda Ospedale - Università Padova

    RECRUITING

    Padova, 35128, Italy

  • Charité - Universitätsmedizin Berlin

    RECRUITING

    Berlin, 10117, Germany

  • Dél-budai Centrumkórház Szent Imre Egyetemi Oktatókórház

    RECRUITING

    Budapest, 1115, Hungary

  • Eszak-Pesti Centrumkorhaz -Honvedkorhaz- Podmaniczky utcai telephely

    RECRUITING

    Budapest, 1062, Hungary

  • Eugastro Klinische Studien GmbH

    RECRUITING

    Leipzig, Saxony, 4103, Germany

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

    RECRUITING

    Milan, 20122, Italy

  • Fondazione Policlinico Universitario A. Gemelli IRCCS - PPDS

    RECRUITING

    Rome, Lazio, 00136, Italy

  • Helsingin Yliopistollinen Keskussairaala

    RECRUITING

    Helsinki, 00290, Finland

  • Hospital General Universitario Gregorio Marañon

    RECRUITING

    Madrid, Madrid, 28007, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, Madrid, 28041, Spain

  • Hospital Universitario Virgen del Rocio - PPDS

    RECRUITING

    Seville, Sevilla, 41013, Spain

  • Karolinska Universitetssjukhuset Solna

    RECRUITING

    Solna, 171 64, Sweden

  • Lied Transplant Center at Nebraska Medical Center

    RECRUITING

    Omaha, Nebraska, 68105, United States

  • New York Presbyterian Hospital-Columbia University Medical Center

    NOT_YET_RECRUITING

    New York, New York, 10032, United States

  • Oslo Universitetssykehus HF, Ullevål

    RECRUITING

    Oslo, 0450, Norway

  • Radboud Universitair Medisch Centrum

    RECRUITING

    Nijmegen, Gelderland, 6525 GA, Netherlands

  • Rigshospitalet-Blegdamsvej 9

    RECRUITING

    Copenhagen, 2100, Denmark

  • Sahlgrenska Universitets sjukhuset

    RECRUITING

    Gothenburg, 413 46, Sweden

  • Samodzielny Publiczny Szpitala Kliniczny im. Prof. Witolda Orlowskiego Centrum Medycznego Kształcenia Podyplomowego

    RECRUITING

    Warsaw, 00-416, Poland

  • Semmelweis Egyetem - Sebészeti, Transzplantációs és Gasztroenterológiai Klinika

    RECRUITING

    Budapest, 1082, Hungary

  • The University of Chicago Medicine

    RECRUITING

    Chicago, Illinois, 60637-1443, United States

  • Universitair Ziekenhuis (UZ) Leuven

    RECRUITING

    Leuven, 3000, Belgium

  • Universitätsklinikum AKH Wien

    RECRUITING

    Vienna, State of Vienna, 1090, Austria

  • Universitätsklinikum Aachen

    RECRUITING

    Aachen, 52074, Germany

  • Universitätsklinikum Bonn

    RECRUITING

    Bonn, 53127, Germany

  • Universitätsmedizin Rostock

    RECRUITING

    Rostock, Mecklenburg-Vorpommern, 18057, Germany

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Washington University Center for Advanced Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Wojewodzki Specjalistyczny Szpital im. M. Pirogowa w Lodzi

    RECRUITING

    Lodz, Lódzkie, 90-531, Poland

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