Clinical Trials

Inclusion Criteria:

• Signed informed consent.
• Either of the following:
  • Completed the full treatment period of the lead-in trial (ZP1848-17111), regardless of treatment adherence; OR
  • Completed the Phase 2 trial (ZP1848-15073).

Exclusion Criteria:

• Withdrew consent from lead-in or Phase 2 trial.
• Any condition, disease, or circumstance that in the Investigator's opinion would put the patient at any undue risk, prevent completion of the trial, or confounds planned assessments of the trial.
• Use of GLP-1, GLP-2, human growth hormone (HGH), dipeptidyl peptidase-4 (DPP-4) inhibitors, citrulline, somatostatin, or analogs thereof within 3 months.
  • Note: Prior glepaglutide trial drug is allowed.
• Females of childbearing potential, who are pregnant, breast-feeding, intend to become pregnant, or are not using highly effective contraceptive methods. Committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
• An employee of the sponsor or Investigator or otherwise dependent on them.

Additional Exclusion Criteria Applicable for Patients from the Phase 2:

Trial Patients from the ZP1848-15073 trial (Phase 2 trial) must be excluded from this trial if any of the following criteria are met:

• Not having a diagnosis of SBS defined as remaining small bowel in continuity of estimated less than 200 cm [equal to 79 inches] with the latest intestinal resection being at least 6 months prior to Screening;
• Restorative surgery planned in the trial period;
• SBS-related hospitalizations within 30 days prior to screening;
• Not maintaining a stable PS volume for at least 2 weeks.
  • Note: PS volume is considered stable if both of the criteria below are fulfilled:
  • Actual PS usage (volume and content) matches prescribed PS (± 10% deviation in volume is acceptable); and
  • Urine volume is on average ≥ 1 L per day and ≤ 2.5 L per day.
• Not willing to adhere to an individual pre-defined drinking menu during 48-hours measurement periods;
• Not having a colonoscopy performed during Screening (for patients with remnant colon).
  • Note: The results of the colonoscopy must not give rise to any safety concerns. A colonoscopy performed within 6 months prior to Screening and not giving rise to any safety concerns is accepted. For patients with a remnant colon, which is not connected to the passage of foods and is thereby dormant, a computerized tomography (CT) scan or magnetic resonance imaging (MRI) will suffice at the discretion of the Investigator.
• Not being able to separate stool and urine during the 48-hours measurement periods;
• Any history of colon cancer;
• History of any other cancers (except margin-free resected cutaneous basal or squamous cell carcinoma or adequately treated in situ cervical cancer) unless disease-free state for at least 5 years;
• Poorly controlled inflammatory bowel disease (IBD) that is moderately or severely active or having a fistula interfering with the trial assessments;
• Bowel obstruction or recent history of sub-ileal events;
• Human immunodeficiency virus (HIV) positive, acute liver disease, or unstable chronic liver disease;
• Cardiac disease defined as: decompensated heart failure (New York Heart Association [NYHA] Class III-IV), unstable angina pectoris, and/or myocardial infarction within the last 6 months prior to Screening;
• Clinically significant abnormal screening ECG as judged by the Investigator;
• Repeated (2 or more consecutive measurements) systolic blood pressure measurements >180 mm Hg;
• Systemic immunosuppressive therapy that has been introduced or has been unstable within 3 months prior to Screening;
• Unstable biological therapy (e.g., TNF-α (anti-tumor necrosis factor), natalizumab, etc.), including significant changes in doses or switch of drug within 6 months prior to Screening;
• Unstable doses within 2 weeks prior to screening:
  • Antimotility drugs; e.g., loperamide, diphenoxylate, codeine or other opiates;
  • H2 antagonists;
  • Anti-diarrheal agents;
  • Bile acid sequestering agents;
  • Oral glutamine;
  • Proton pump inhibitors;
  • Diuretics;
  • Systemic antibiotics or antibiotics affecting the gastrointestinal tract;
  • Oral rehydration fluids.
• Estimated creatinine clearance (CLcr; by the Cockcroft-Gault formula) < 30 mL/min.;
• Hepatic impairment defined as:
  • Total bilirubin ≥ 2 × the upper limit of normal (ULN); or
  • Aspartate aminotransferase (AST) ≥ 5 × ULN; or
  • Alanine aminotransferase (ALT) ≥ 5 × ULN.