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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 0 in lead-in trial (ease sbs 1), week 108
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0 in lead-in trial (ease sbs 1), week 108
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 moreEASE 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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had a colonoscopy at the end of the EASE SBS 2 trial, or it was safe.I haven't used GLP-1, GLP-2, HGH, DPP-4 inhibitors, or somatostatin in the last 3 months.I am not pregnant, breastfeeding, planning to become pregnant, or using effective birth control.You have a medical condition that may cause risks, may interfere with completing the study, or may affect the results of the trial.
Research Study Groups:
This trial has the following groups:- Group 1: once-weekly glepaglutide
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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