Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS

The trial is a phase 3, double-blind, randomized, parallel-group, placebo-controlled, multicenter trial to confirm the efficacy and safety of glepaglutide 10 mg twice weekly, followed by a long-term, open-label safety evaluation in patients with short bowel syndrome-intestinal failure (SBS-IF).

• Glepaglutide (Drug), also known as ZP1848: Subcutaneous (SC) injections twice weekly
• Placebo (Other): SC injections twice weekly

Primary outcomes

• Change in weekly Parenteral Support (PS) volume [Baseline to Week 24]

Secondary outcomes

• Proportion of participants achieving clinical response [Baseline to Week 52]: Defined as achieving a reduction of at least 20% in weekly PS volume
• Proportion of participants achieving clinical response [Baseline to Week 20 and Week 24]: Defined as achieving a reduction of at least 20% in weekly PS volume
• Proportion of participants with a reduction in days on PS ≥1 day/week [Baseline to Week 52]
• Proportion of participants with a reduction in days on PS ≥1 day/week [Baseline to Week 24]
• Proportion of participants with a reduction of 100% weekly PS volume (weaned-off) [Baseline to Week 52]
• Proportion of participants with a reduction of 100% weekly PS volume (weaned-off) [Baseline to Week 24]
• Proportion of participants achieving 'much better' Patient Global Impression of Change (PGIC) status [Week 24]: PGIC scoring categories are: 'Much better', 'A little better', 'No change', 'A little worse', and 'Much worse'
• Change in weekly PS volume [Baseline to Week 12]
• Change in weekly PS volume [Baseline to Week 8]
• Incidence of Treatment Emergent Adverse Events (TEAEs) [Baseline to Week 52]

Sex: All, ages: 18 Years to 90 Years

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.