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NCT04881825 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Short Bowel Syndrome, sponsored by Zealand Pharma.

Active
Registry status
Phase 3
Development phase
129
Enrollment target
19
Study locations

NCT04881825 is a Phase 3 study of Short Bowel Syndrome that is active but no longer recruiting, run by Zealand Pharma. The registered enrollment target is 129 participants, below the 177-participant average among 17 other Short Bowel Syndrome trials with a reported enrollment target (27% lower). The trial reports 19 study locations across 5 states.

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The verdict

NCT04881825, a Phase 3 study of Short Bowel Syndrome, is active but no longer recruiting, sponsored by Zealand Pharma.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
129 participants
Enrollment target
19
Study locations

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.

Conditions Studied

Short Bowel Syndrome

Interventions

  • DRUG Glepaglutide

Study Locations (19)

Other

  • Universitair Ziekenhuis Leuven - Leuven
  • Rigshospitalet - Copenhagen
  • Hôpital Beaujon - Clichy
  • Centre Hospitalier Lyon-Sud - Pierre-Bénite
  • Charité - Universitätsmedizin Berlin - Berlin
  • Universitätsklinikum Bonn - Bonn
  • Universitätsklinikum Frankfurt - Frankfurt
  • Asklepios Kliniken Hamburg GmbH - Hamburg
  • Universitätsmedizin Rostock - Rostock
  • UMC Radboud Nijmegen - Nijmegen
  • Wojewodzki Specjalistyczny Szpital im. M. Pirogowa w Lodzi - Lodz
  • Szpital Skawina sp. z o.o. im. Stanley Dudricka - Skawina
  • St Mark's Hospital - Harrow
  • UCLH Foundation NHS Trust - London
  • Norfolk and Norwich University Hospitals - Norwich

District of Columbia

  • Georgetown University Medical Center - Washington D.C.

Minnesota

  • Mayo Clinic College of Medicin - Rochester

Nebraska

  • University of Nebraska Medical Center - Omaha

Tennessee

  • Vanderbilt University Medical Center, Nashville - Nashville

Trial Details

FieldValue
Enrollment Target 129 participants
Start Date 2021-06-16
Est. Completion 2026-04
Phase Phase 3

Sponsor

Zealand Pharma

18 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04881825

The ClinicalTrials.gov registry entry for NCT04881825 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 129 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 177-participant average among 17 other Short Bowel Syndrome trials with a reported enrollment target (27% lower). The listed sponsor is Zealand Pharma, which has 18 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Short Bowel Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Glepaglutide is the first listed.

NCT04881825 reports 19 study locations spanning 5 distinct geographic areas - top geographies include Other, District of Columbia, Minnesota.

Frequently Asked Questions

What is clinical trial NCT04881825 about?

NCT04881825 is a clinical study titled "Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS - Extension Trial". 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-weekl...

What is the current status of trial NCT04881825?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 129 participants. The study started on 2021-06-16. Estimated completion is 2026-04.

What conditions does trial NCT04881825 study?

This clinical trial studies the following conditions: Short Bowel Syndrome.

What interventions are being tested in trial NCT04881825?

The interventions under investigation include: Glepaglutide (DRUG).

Who is sponsoring clinical trial NCT04881825?

This trial is sponsored by Zealand Pharma, which has 18 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04881825 being conducted?

This trial has 19 study locations across District of Columbia, Minnesota, Nebraska, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.