Your session is about to expire
← Back to Search
Glucagon-Like Peptide-2 (GLP-2) Analog
Glepaglutide for Short Bowel Syndrome (EASE SBS 2 Trial)
Phase 3
Recruiting
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 2 years
Awards & highlights
EASE SBS 2 Trial Summary
This trial is designed to see if glepaglutide is a safe treatment for patients with short bowel syndrome.
Who is the study for?
This trial is for patients with Short Bowel Syndrome who completed previous related trials (ZP1848-17111 or ZP1848-15073) and gave informed consent. It's not for those at undue risk, pregnant or breastfeeding women, or anyone using certain growth hormones within the last 3 months.Check my eligibility
What is being tested?
The trial tests the long-term safety and effectiveness of a drug called glepaglutide in treating Short Bowel Syndrome. Glepaglutide is also known as ZP1848.See study design
What are the potential side effects?
While specific side effects are not listed here, generally such treatments may cause digestive issues, discomfort at injection sites, potential hormonal imbalances, and could affect blood sugar levels.
EASE SBS 2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety - Adverse Events
Secondary outcome measures
Change in weekly Parenteral Support (PS) volume
Changes in fluid composite effect
Days off PS
+12 moreEASE SBS 2 Trial Design
2Treatment groups
Experimental Treatment
Group I: Glepaglutide SC injections twice weeklyExperimental Treatment1 Intervention
Glucagon-Like Peptide-2 (GLP-2) analog, 10 mg subcutaneous injection twice weekly.
In this long term safety study, there is no placebo arm.
Group II: Glepaglutide SC injections once weekly and placebo once weeklyExperimental Treatment1 Intervention
Glucagon-Like Peptide-2 (GLP-2) analog, 10 mg subcutaneous injection once weekly and placebo once weekly.
In this long term safety study, there is no placebo arm.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
glepaglutide
2018
Completed Phase 3
~110
Find a Location
Who is running the clinical trial?
Zealand PharmaLead Sponsor
37 Previous Clinical Trials
2,633 Total Patients Enrolled
4 Trials studying Short Bowel Syndrome
265 Patients Enrolled for Short Bowel Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant, breastfeeding, planning to become pregnant, or using effective birth control.I haven't used GLP-1, GLP-2, growth hormone, or similar drugs in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Glepaglutide SC injections twice weekly
- Group 2: Glepaglutide SC injections once weekly and placebo once weekly
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger