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Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS

RecruitingPhase 3Ages 18 Years - 90 YearsAllZealand Pharma
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In plain words

What the trial is, and whether it could suit you

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 generate additional long-term safety data. Glepaglutide is the International Nonproprietary Name and United States Adopted Name (USAN) for ZP1848.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Key Inclusion Criteria: * Signed informed consent; * Age of 18 to 90 years; * A diagnosis of SBS, defined as having a small bowel with an estimated length of less than 200 cm (equal to 79 inches) in continuity (latest intestinal resection ≥6 months before screening); * Stable PS need of ≥3 days per week; * No restorative surgery planned during the trial period; * Having a stoma or colon in continuity. Key Exclusion Criteria: * More than 2 SBS- or PS-related hospitalizations within 6 months before screening; * Poorly controlled Inflammatory Bowel Disease (IBD) that is moderately or severely active or a fistula that can interfere with the measurements or examinations required in the trial; * History of colorectal cancer or any other type of cancer (except for margin-free resected cutaneous basal, squamous cell carcinoma or adequately treated in situ cervical cancer) unless the patient has been disease-free for at least 5 years; ongoing bowel obstruction; * BMI \<18.5 kg/m\^2.
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What it tests

  • Glepaglutide
  • Placebo
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Where

33 sites
The University of Chicago Medicine
Chicago, United States
Washington University Center for Advanced Medicine
St Louis, United States
Lied Transplant Center at Nebraska Medical Center
Omaha, United States
New York Presbyterian Hospital-Columbia University Medical Center
New York, United States
UPMC Starzl Transplantation Institute
Pittsburgh, United States
Vanderbilt University Medical Center
Nashville, United States
Universitätsklinikum AKH Wien
Vienna, Austria
Universitair Ziekenhuis (UZ) Leuven
Leuven, Belgium

…and 25 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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