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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Glepaglutide
DrugSubcutaneous (SC) injections twice weekly
Placebo
Other interventionSC injections twice weekly
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Glepaglutide GroupExperimental treatment 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in weekly Parenteral Support (PS) volume
Time frame
Baseline to Week 24Secondary outcomes
1
Proportion of participants achieving clinical response
Defined as achieving a reduction of at least 20% in weekly PS volume
Time frame
Baseline to Week 522
Proportion of participants achieving clinical response
Defined as achieving a reduction of at least 20% in weekly PS volume
Time frame
Baseline to Week 20 and Week 243
Proportion of participants with a reduction in days on PS ≥1 day/week
Time frame
Baseline to Week 524
Proportion of participants with a reduction in days on PS ≥1 day/week
Time frame
Baseline to Week 24Sponsors and contacts
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Source ClinicalTrials.gov