Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS - Extension Trial

Last updated: November 23, 2023
Sponsor: Zealand Pharma
Overall Status: Active - Enrolling

Phase

3

Condition

Bowel Dysfunction

Treatment

Glepaglutide

Clinical Study ID

NCT04881825
ZP1848-20110
U1111-1261-3358
2020-005502-25
  • Ages 18-90
  • All Genders

Study Summary

This trial is an extension trial to EASE SBS 2. The study looks at whether glepaglutide is a safe treatment for participants with Short Bowel Syndrome (SBS), as well as how well effectiveness is maintained during long term treatment. Participants in this trial will receive glepaglutide as once-weekly injections under the skin (subcutaneous, s.c.) for approximately 2 years.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Any condition, disease, or circumstance that in the Investigator's opinion would putthe patient at any undue risk, prevent completion of the trial, or confound theplanned assessments of the trial
  • Not having a colonoscopy performed at End of Trial in EASE SBS 2 (for patients withremnant colon). Note. The results of the colonoscopy must not give rise to any safetyconcerns. A colonoscopy performed within 6 months prior to End of Trial and not givingrise to any safety concerns is accepted. For patients with a remnant colon, which isnot connected to the passage of foods and is thereby dormant, a computerizedtomography (CT) scan or magnetic resonance imaging (MRI) will suffice at thediscretion 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 ofglepaglutide trial drug is allowed
  • Females of childbearing potential, who are pregnant, breast-feeding, intend to becomepregnant, or are not using highly effective contraceptive methods

Study Design

Total Participants: 129
Treatment Group(s): 1
Primary Treatment: Glepaglutide
Phase: 3
Study Start date:
June 16, 2021
Estimated Completion Date:
April 30, 2025

Connect with a study center

  • Universitair Ziekenhuis Leuven

    Leuven,
    Belgium

    Site Not Available

  • Rigshospitalet

    Copenhagen,
    Denmark

    Site Not Available

  • Hôpital Beaujon

    Clichy,
    France

    Site Not Available

  • Centre Hospitalier Lyon-Sud

    Pierre-Bénite,
    France

    Site Not Available

  • Charité - Universitätsmedizin Berlin

    Berlin,
    Germany

    Site Not Available

  • Universitätsklinikum Bonn

    Bonn, 53127
    Germany

    Site Not Available

  • Universitätsklinikum Frankfurt

    Frankfurt,
    Germany

    Site Not Available

  • Asklepios Kliniken Hamburg GmbH

    Hamburg,
    Germany

    Site Not Available

  • Universitätsmedizin Rostock

    Rostock,
    Germany

    Site Not Available

  • UMC Radboud Nijmegen

    Nijmegen,
    Netherlands

    Site Not Available

  • Solumed

    Poznań,
    Poland

    Site Not Available

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

    Skawina,
    Poland

    Site Not Available

  • Wojewodzki Specjalistyczny Szpital im. M. Pirogowa w Lodzi

    Łódź,
    Poland

    Site Not Available

  • St Mark's Hospital

    Harrow,
    United Kingdom

    Site Not Available

  • UCLH Foundation NHS Trust

    London,
    United Kingdom

    Site Not Available

  • Norfolk and Norwich University Hospitals

    Norwich,
    United Kingdom

    Site Not Available

  • Georgetown University Medical Center

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • Mayo Clinic College of Medicin

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • University of Nebraska Medical Center

    Omaha, Nebraska 68198
    United States

    Site Not Available

  • Vanderbilt University Medical Center, Nashville

    Nashville, Tennessee 68198-3285
    United States

    Site Not Available

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