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Tests treatment safety and results for Short Bowel Syndrome
Official title Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS
ClinicalTrials.gov ID: NCT07197944
What this study is testing
What is Glepaglutide?
Glepaglutide is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for short bowel syndrome.
Also referred to as ZP1848.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- 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...
- Stable PS need of ≥3 days per week;
- No restorative surgery planned during the trial period;
You likely can't join if
- 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...
- History of colorectal cancer or any other type of cancer (except for margin-free resected cutaneous basal, squamous cell carcinoma or adequately...
- BMI \<18.5 kg/m\^2.
See the full eligibility 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
- 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...
- BMI \<18.5 kg/m\^2.
The study team makes the final eligibility decision.
Where it's taking place
- St Louis, Missouri, United States
- Omaha, Nebraska, United States
- New York, New York, United States
- Nashville, Tennessee, United States
- Vienna, State of Vienna, Austria
- Copenhagen, Denmark
- Clichy, France
- Rostock, Mecklenburg-Vorpommern, Germany
- Leipzig, Saxony, Germany
- Berlin, Germany
- Bonn, Germany
- Hamburg, Germany
- Budapest, Hungary
- Rome, Lazio, Italy
- Nijmegen, Gelderland, Netherlands
- Oslo, Norway
- Lodz, Lódzkie, Poland
- Warsaw, Poland
- Madrid, Spain
- Seville, Spain
+ 2 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include St Louis, Missouri, United States; Omaha, Nebraska, United States; New York, New York, United States; Nashville, Tennessee, United States; Vienna, State of Vienna, Austria; Copenhagen, Denmark and 16 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.