Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS
ConditionShort Bowel Syndrome
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-90
SponsorZealand Pharma
About this trial
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 criteria
Qualifiers
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;
Disqualifiers
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/m².
Trial design
Treatments tested in this trial
- Glepaglutide
- Placebo
Treatment groups
90 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov