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Glucagon-like peptide-2 (GLP-2) analog

Glepaglutide for Short Bowel Syndrome (EASE SBS 3 Trial)

Phase 3
Waitlist Available
Research Sponsored by Zealand Pharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 0 in lead-in trial (ease sbs 1), week 108
Awards & highlights

EASE SBS 3 Trial Summary

This trial is an extension of EASE SBS 2 and looks at whether glepaglutide is a safe and effective treatment for Short Bowel Syndrome.

Who is the study for?
This trial is for individuals who have completed the EASE SBS 2 trial for Short Bowel Syndrome (SBS) and are not using certain other medications or treatments. Women must use effective contraception if of childbearing potential, and participants should not have any conditions that may interfere with the study.Check my eligibility
What is being tested?
The study tests the long-term safety and effectiveness of glepaglutide in treating SBS. Participants will receive weekly subcutaneous injections of glepaglutide over a period of approximately two years.See study design
What are the potential side effects?
While specific side effects are not listed here, common side effects from similar treatments include digestive issues, injection site reactions, fatigue, and possible allergic responses.

EASE SBS 3 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0 in lead-in trial (ease sbs 1), week 108
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0 in lead-in trial (ease sbs 1), week 108 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence and type of Adverse Events (AEs)
Secondary outcome measures
Anti-glepaglutide antibodies
Antibody reactivity to ZP1848
Change in biochemistry - C-reactive protein
+47 more

EASE SBS 3 Trial Design

1Treatment groups
Experimental Treatment
Group I: once-weekly glepaglutideExperimental Treatment1 Intervention
All participants will receive 10 mg of glepaglutide as once-weekly injections under the skin (subcutaneous, s.c.)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Glepaglutide
2017
Completed Phase 3
~190

Find a Location

Who is running the clinical trial?

Zealand PharmaLead Sponsor
37 Previous Clinical Trials
2,649 Total Patients Enrolled
4 Trials studying Short Bowel Syndrome
281 Patients Enrolled for Short Bowel Syndrome

Media Library

Glepaglutide (Glucagon-like peptide-2 (GLP-2) analog) Clinical Trial Eligibility Overview. Trial Name: NCT04881825 — Phase 3
Short Bowel Syndrome Research Study Groups: once-weekly glepaglutide
Short Bowel Syndrome Clinical Trial 2023: Glepaglutide Highlights & Side Effects. Trial Name: NCT04881825 — Phase 3
Glepaglutide (Glucagon-like peptide-2 (GLP-2) analog) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04881825 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are able to enroll in this clinical trial?

"At the moment, this study is not recruiting patients. The trial was first posted on June 16th 2021 and was last edited on March 7th 2022. For those looking for similar studies, 1454 trials concerning short bowel syndrome are currently enrolling participants along with 2 other clinical trials involving Glepaglutide."

Answered by AI

Is this clinical trial using cutting-edge methods?

"Glepaglutide is being studied in 2 trials that are currently ongoing. These studies began in 2021 and, so far, have taken place across 8 countries. So far, 129 patients have completed Phase 3 drug approval stages."

Answered by AI

How can I become a subject in this experiment?

"To be a part of this clinical trial, patients must between 18 and 90 years old with short bowel syndrome. Additionally, they must have completed the full treatment period of the extension trial EASE SBS 2 (ZP1848-17127) and given their informed consent for participation."

Answered by AI

Does this research include testing on elderly patients?

"In order to be included in this particular trial, patients must fall within the age bracket of 18 to 90 years old. There are 388 other trials for people that are under 18 and 1037 for seniors."

Answered by AI

Are people still able to enroll in this clinical trial?

"This study, which was last updated on March 7th, 2022 is not currently looking for patients. However, there are many other medical trials (1456 to be exact) that are still recruiting individuals."

Answered by AI

What are some of the possible risks associated with Glepaglutide?

"Glepaglutide's safety is based on data from prior Phase 3 trials, and it received a score of 3."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS - Extension Trial
2021. "Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS - Extension Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04881825.
~32 spots leftby Apr 2025
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