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The Long-term Effect on Intestinal Absorption and Safety of Treatment With Glepaglutide in Patients With Short Bowel Syndrome | Clinical Trials | Clareo Health

COMPLETEDPHASE3

The Long-term Effect on Intestinal Absorption and Safety of Treatment With Glepaglutide in Patients With Short Bowel Syndrome

A Single-Center Phase 3b Trial Investigating the Long-term Effect on Intestinal Absorption, Nutritional Status and Long-Term Safety of Treatment With Glepaglutide in Patients With Short Bowel Syndrome (SBS)

NCT04991311•Zealand Pharma

View on ClinicalTrials.gov

Summary

The purpose of this trial is to investigate the long-term effect of glepaglutide on the intestinal absorption, nutritional status of participants with Short Bowel Syndrome (SBS). The trial will also investigate whether glepaglutide is safe during long-term use. All participants in the trial will receive glepaglutide injections. Participants will have 14 visits with the study doctor. At 2 of these, participants will spend 48 hours at the trial site, one visit at the start of the trial and one after 24 weeks of treatment with glepaglutide. At all visits, participants will meet with trial staff and will have blood tests along with other clinical checks and tests done. Participants will be asked about their health and medical history.

Eligibility

Age

18 - 90 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
•Age greater than or equal to 18 years and less than or equal to 90 years at screening
•Stable condition of SBS either with intestinal failure (SBS-IF) or intestinal insufficiency. For patients with SBS-IF, a stable condition is defined as less than 25 percent change in parenteral support (PS) volume or energy content for 4 weeks prior to screening.
•Stable body weight (less than 5 percent change in weight in the 3 months prior to screening)
•Wet weight of fecal excretion greater than or equal to 1500 grams per day demonstrated during a hospital stay prior to screening

Exclusion Criteria

•More than 2 SBS-related or PS-related hospitalizations (e.g., catheter-related bacteremia/sepsis, bowel obstruction, severe water-electrolytes disturbances, etc.) within 6 months prior to screening
•Poorly controlled inflammatory bowel disease (IBD) that is moderately or severely active or fistula interfering with measurements or examinations required in the trial
•Current bowel obstruction
•Known radiation enteritis or significant villous atrophy, e.g., due to active celiac disease
•Cardiac disease defined as: decompensated heart failure (New York Heart Association \[NYHA\] Class III-IV), unstable angina pectoris, and/or myocardial infarction within the last 6 months prior to screening
•Any history of colon cancer. History of any other cancers (except margin-free resected cutaneous basal or squamous cell carcinoma or adequately treated in situ cervical cancer) unless disease-free state for at least 5 years
•Use of glucagon-like peptide-1 (GLP-1), GLP-2, human growth hormone (HGH), somatostatin, or analogs thereof, within 3 months prior to screening

Locations (1)

Rigshospitalet

Copenhagen, Denmark

Key Dates

Start Date

August 10, 2021

Primary Completion Date

February 2, 2023

Completion Date

September 5, 2023

Last Updated

November 22, 2024

Enrollment

ACTUAL participants

Conditions

Short Bowel Syndrome

Interventions

Glepaglutide

DRUG

Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS

NCT07197944

Short Bowel Syndrome

View study

RECRUITING

A Survey to Assess Participants' and Physicians' Knowledge When Using GATTEX (Knowledge Assessment Survey)

NCT05561647

Short Bowel Syndrome (SBS)

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RECRUITINGPHASE3

A Study of Teduglutide in Chinese Adults With Short Bowel Syndrome

NCT06973304

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 22, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The Long-term Effect on Intestinal Absorption and Safety of Treatment With Glepaglutide in Patients With Short Bowel Syndrome

Inclusion Criteria

Exclusion Criteria

Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS

A Survey to Assess Participants' and Physicians' Knowledge When Using GATTEX (Knowledge Assessment Survey)

A Study of Teduglutide in Chinese Adults With Short Bowel Syndrome

A 90 Day Observational Study as an Extension to the Phase 3,Open Labeled Exploratory Study of RELiZORB

Registry for Participants With Short Bowel Syndrome

Assessing Metabolic and Sleep Consequences of Overnight Home Parenteral Nutrition