Glepaglutide for Short Bowel Syndrome
(EASE SBS 5 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a treatment called glepaglutide for individuals with Short Bowel Syndrome (SBS), a condition where part of the intestine is missing or not functioning properly. The main goal is to determine if glepaglutide is effective and safe for those who rely on parenteral support (nutrition or hydration given through a vein) at least three times a week. Participants will receive either glepaglutide or a placebo to compare results. Those who have had SBS for a while, require regular parenteral support, and have no planned surgeries might find this trial suitable. As a Phase 3 trial, this study represents the final step before FDA approval, offering a chance to contribute to a potentially groundbreaking treatment.
Is there any evidence suggesting that glepaglutide is likely to be safe for humans?
Research has shown that glepaglutide, a treatment for short bowel syndrome, is safe and well-tolerated. Participants in previous studies experienced significant improvements in their condition, with only minor side effects. Some studies highlighted that glepaglutide reduced the need for intravenous nutrition without causing serious problems. This suggests that patients generally receive the treatment well, with safety data supporting its use in clinical trials.12345
Why do researchers think this study treatment might be promising for short bowel syndrome?
Glepaglutide is unique for treating Short Bowel Syndrome because it mimics a natural hormone in the body called glucagon-like peptide-2 (GLP-2). This hormone plays a crucial role in helping the intestines absorb nutrients more effectively. Unlike current treatments, which often involve complex surgeries or nutrient infusions, glepaglutide offers a simpler, peptide-based approach that directly enhances intestinal function. Researchers are excited because this mechanism could lead to improved nutrient absorption and overall quality of life for patients without the need for invasive procedures.
What evidence suggests that glepaglutide might be an effective treatment for Short Bowel Syndrome?
Studies have shown that glepaglutide effectively treats short bowel syndrome (SBS). Patients with SBS who received glepaglutide absorbed more nutrients and fluids, reducing their need for parenteral support. One study found that 65.7% of patients taking glepaglutide experienced a significant positive response. Participants in this trial will receive either glepaglutide or a placebo. These findings suggest that glepaglutide can help people with SBS rely less on external nutritional support, enhancing their quality of life.12367
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive glepaglutide 10 mg twice weekly or placebo
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension
Participants may opt into continuation of glepaglutide treatment long-term
What Are the Treatments Tested in This Trial?
Interventions
- Glepaglutide
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Placebo for glepaglutide
Find a Clinic Near You
Who Is Running the Clinical Trial?
Zealand Pharma
Lead Sponsor
Citations
Outcomes of glepaglutide on intestinal absorption and ...
Outcomes of glepaglutide on intestinal absorption and parenteral support in patients with short bowel syndrome · Authors · Affiliations.
Outcomes of glepaglutide on intestinal absorption and ...
Patients with SBS treated with glepaglutide demonstrated increased intestinal wet weight and energy absorption, allowing corresponding reductions in PS ...
Glepaglutide efficacy and safety in short bowel syndrome ...
Glepaglutide treatment of SBS-IF resulted in significant reductions in PS and the ability to achieve enteral autonomy in both patients without or with CiC.
Study Details | NCT07197944 | Efficacy And Safety ...
The purpose of the present Phase 3 trial is to confirm the efficacy and safety of glepaglutide 10 mg twice weekly in a patient population with SBS-IF and ...
Glepaglutide, a Long-Acting Glucagon-like Peptide-2 ...
Glepaglutide treatment in patients with SBS with intestinal failure resulted in clinically relevant reductions in PS requirements and was ...
6.
ctv.veeva.com
ctv.veeva.com/study/efficacy-and-safety-evaluation-of-glepaglutide-in-treatment-of-short-bowel-syndrome-sbsEfficacy And Safety Evaluation of Glepaglutide in Treatment of ...
The primary objective of the trial is to confirm the efficacy of glepaglutide in reducing parenteral support volume in patients with short ...
Potential and Challenges of Glepaglutide for SBS-IF
In addition, long-term safety endpoints related to the prointestinal proliferative effects of the drug (eg, mucosal hyperplasia-associated ...
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