NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS

NCT07197944

RecruitingPhase 3

Sponsor: Zealand Pharma

Conditions: Short Bowel Syndrome

Interventions: Glepaglutide, Placebo

Countries: United States, Austria, Belgium, Denmark, Finland, France, Germany, Hungary

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 90 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (31)

Chicago, Illinois, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
New York, New York, United States
Nashville, Tennessee, United States
Vienna, State of Vienna, Austria
Leuven, Belgium
Copenhagen, Denmark
Helsinki, Finland
Clichy, France
Rostock, Mecklenburg-Vorpommern, Germany
Leipzig, Saxony, Germany
Aachen, Germany
Berlin, Germany
Bonn, Germany
Hamburg, Germany
Budapest, Hungary
Budapest, Hungary
Budapest, Hungary
Rome, Lazio, Italy
Milan, Italy
Padova, Italy
Nijmegen, Gelderland, Netherlands
Oslo, Norway
Lodz, Lódzkie, Poland
Warsaw, Poland
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Seville, Sevilla, Spain
Gothenburg, Sweden
+ 1 more on CT.gov