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RECRUITING Phase 3 ClinicalTrials.gov

Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS

Sponsor: Zealand Pharma • ClinicalTrials.gov ID: NCT07197944

Registry updated: 2026-09-29
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Description

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.

Interventions

  • Glepaglutide (Drug)
    Subcutaneous (SC) injections twice weekly
  • Placebo (Other)
    SC injections twice weekly

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.

Conditions

Short Bowel Syndrome

Locations

  • The University of Chicago Medicine — Chicago, Illinois, United States
  • Washington University Center for Advanced Medicine — St Louis, Missouri, United States
  • Lied Transplant Center at Nebraska Medical Center — Omaha, Nebraska, United States
  • New York Presbyterian Hospital-Columbia University Medical Center — New York, New York, United States
  • UPMC Starzl Transplantation Institute — Pittsburgh, Pennsylvania, United States
  • Vanderbilt University Medical Center — Nashville, Tennessee, United States
  • Universitätsklinikum AKH Wien — Vienna, State of Vienna, Austria
  • Universitair Ziekenhuis (UZ) Leuven — Leuven, Belgium
  • Rigshospitalet-Blegdamsvej 9 — Copenhagen, Denmark
  • Helsingin Yliopistollinen Keskussairaala — Helsinki, Finland
  • AP-HP - Hôpital Beaujon — Clichy, France
  • Universitätsmedizin Rostock — Rostock, Mecklenburg-Vorpommern, Germany
  • Eugastro Klinische Studien GmbH — Leipzig, Saxony, Germany
  • Universitätsklinikum Aachen — Aachen, Germany
  • Charité - Universitätsmedizin Berlin — Berlin, Germany
  • Universitätsklinikum Bonn — Bonn, Germany
  • Asklepios Klinik St. Georg — Hamburg, Germany
  • Eszak-Pesti Centrumkorhaz -Honvedkorhaz- Podmaniczky utcai telephely — Budapest, Hungary
  • Semmelweis Egyetem - Sebészeti, Transzplantációs és Gasztroenterológiai Klinika — Budapest, Hungary
  • Dél-budai Centrumkórház Szent Imre Egyetemi Oktatókórház — Budapest, Hungary
  • Fondazione Policlinico Universitario A. Gemelli IRCCS - PPDS — Rome, Lazio, Italy
  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico — Milan, Italy
  • Azienda Ospedale - Università Padova — Padova, Italy
  • Radboud Universitair Medisch Centrum — Nijmegen, Gelderland, Netherlands
  • Oslo Universitetssykehus HF, Ullevål — Oslo, Norway
  • Wojewodzki Specjalistyczny Szpital im. M. Pirogowa w Lodzi — Lodz, Lódzkie, Poland
  • Szpital Skawina sp. z o.o. im. Stanley Dudricka — Skawina, Poland
  • Samodzielny Publiczny Szpitala Kliniczny im. Prof. Witolda Orlowskiego Centrum Medycznego Kształcenia Podyplomowego — Warsaw, Poland
  • Hospital General Universitario Gregorio Marañon — Madrid, Madrid, Spain
  • Hospital Universitario 12 de Octubre — Madrid, Madrid, Spain
  • Hospital Universitario Virgen del Rocio - PPDS — Seville, Sevilla, Spain
  • Sahlgrenska Universitets sjukhuset — Gothenburg, Sweden
  • Karolinska Universitetssjukhuset Solna — Solna, Sweden
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record