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NCT07197944From ClinicalTrials.govRecruiting

Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS

A Phase 3, Double-blind, Randomized, Parallel Group, Placebo-controlled, Multicenter Trial to Confirm the Efficacy and Safety of Glepaglutide 10 mg Twice Weekly, Followed by a Long-term, Open-label Safety Evaluation in Patients With Short Bowel Syndrome-intestinal Failure (SBS-IF)

  • Short Bowel Syndrome

At a glance

Phase
Phase 3
Study type
Interventional
Sponsor
Zealand Pharma
Enrolment target
90
Started
11 February 2026
Main results due
23 October 2028
Study sites
33
Registry updated
29 September 2026

Can you take part?

  • Ages 18 years to 90 years.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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.

What this study is about

In the sponsor’s own words, from the registry.

The purpose of the present Phase 3 trial is to confirm the efficacy and safety of glepaglutide 10 mg twice weekly in a patient population with SBS-IF and generate additional long-term safety data.

Glepaglutide is the International Nonproprietary Name and United States Adopted Name (USAN) for ZP1848.

Study sites(33)

  • The University of Chicago Medicine

    Chicago, Illinois, United States

    Recruiting

  • Washington University Center for Advanced Medicine

    St Louis, Missouri, United States

    Recruiting

  • Lied Transplant Center at Nebraska Medical Center

    Omaha, Nebraska, United States

    Recruiting

  • New York Presbyterian Hospital-Columbia University Medical Center

    New York, New York, United States

    Not yet recruiting

  • UPMC Starzl Transplantation Institute

    Pittsburgh, Pennsylvania, United States

    Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee, United States

    Recruiting

  • Universitätsklinikum AKH Wien

    Vienna, State of Vienna, Austria

    Recruiting

  • Universitair Ziekenhuis (UZ) Leuven

    Leuven, Belgium

    Recruiting

  • Rigshospitalet-Blegdamsvej 9

    Copenhagen, Denmark

    Recruiting

  • Helsingin Yliopistollinen Keskussairaala

    Helsinki, Finland

    Recruiting

  • AP-HP - Hôpital Beaujon

    Clichy, France

    Recruiting

  • Universitätsmedizin Rostock

    Rostock, Mecklenburg-Vorpommern, Germany

    Recruiting

  • Eugastro Klinische Studien GmbH

    Leipzig, Saxony, Germany

    Recruiting

  • Universitätsklinikum Aachen

    Aachen, Germany

    Recruiting

  • Charité - Universitätsmedizin Berlin

    Berlin, Germany

    Recruiting

  • Universitätsklinikum Bonn

    Bonn, Germany

    Recruiting

  • Asklepios Klinik St. Georg

    Hamburg, Germany

    Recruiting

  • Eszak-Pesti Centrumkorhaz -Honvedkorhaz- Podmaniczky utcai telephely

    Budapest, Hungary

    Recruiting

  • Semmelweis Egyetem - Sebészeti, Transzplantációs és Gasztroenterológiai Klinika

    Budapest, Hungary

    Recruiting

  • Dél-budai Centrumkórház Szent Imre Egyetemi Oktatókórház

    Budapest, Hungary

    Recruiting

  • Fondazione Policlinico Universitario A. Gemelli IRCCS - PPDS

    Rome, Lazio, Italy

    Recruiting

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

    Milan, Italy

    Recruiting

  • Azienda Ospedale - Università Padova

    Padova, Italy

    Recruiting

  • Radboud Universitair Medisch Centrum

    Nijmegen, Gelderland, Netherlands

    Recruiting

  • Oslo Universitetssykehus HF, Ullevål

    Oslo, Norway

    Recruiting

  • Wojewodzki Specjalistyczny Szpital im. M. Pirogowa w Lodzi

    Lodz, Lódzkie, Poland

    Recruiting

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

    Skawina, Poland

    Recruiting

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

    Warsaw, Poland

    Recruiting

  • Hospital General Universitario Gregorio Marañon

    Madrid, Madrid, Spain

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, Spain

    Recruiting

  • Hospital Universitario Virgen del Rocio - PPDS

    Seville, Sevilla, Spain

    Recruiting

  • Sahlgrenska Universitets sjukhuset

    Gothenburg, Sweden

    Recruiting

  • Karolinska Universitetssjukhuset Solna

    Solna, Sweden

    Recruiting

Showing 33 of 33 sites. 32 of the 33 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07197944. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS | Trialion