Clinical Trials

Inclusion Criteria:

• Signed informed consent for this trial prior to any trial specific assessment.
• Male and female subjects with SBS-IF secondary to surgical resection of the small intestine with either:
  • ≥ 50% CIC remaining and no stoma with the latest intestinal resection being at least 12 months prior to Screening; OR
  • Jejunostomy or ileostomy (< 200 cm from duodeno-jejunal flexure, based on available medical/surgical records) with the latest intestinal resection being at least 6 months prior to Screening.
• Subject is considered optimized (drinking volume is between ≥ 1.0 and ≤ 3.5 L per day and the urinary volume is between ≥ 0.8 L and ≤ 2.5 L per day) at clinical Visit 2a, 2b, or 2c and 4.
• Subject is considered stable for at least 2 weeks before randomization with regards to PS volume requirement, drinking volume and urinary output at clinical Visit 3a and 3b.
• Parenteral support requirement of at least 3 days per week as assessed before Screening and at the time of randomization.
• Willingness to adhere to an individual pre-defined drinking menu and urine measurements during the 48-hour measuring periods.
• No restorative surgery planned in the trial period
• Age ≥ 18 years at Screening.
• Women of childbearing potential must agree to practice effective contraception and to use a highly effective method of contraception during the trial and for 4 weeks after the End of Trial (EOT) Visit. Such methods include: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner. To be considered sterilized or infertile, females must have undergone surgical sterilization (bilateral tubectomy, hysterectomy or bilateral ovariectomy) or be post-menopausal (defined as at least 12 months amenorrhea may be confirmed with follicle-stimulating hormone test if there is doubt).
•  Male subjects with a female partner of childbearing potential must commit to practice highly effective methods of contraception (e.g., condom) and abstain from sperm donation during the trial and for 2 weeks after the EOT Visit.

Exclusion Criteria:

• Pregnancy or lactation.
• Body mass index equal or higher than 30 kg/m^2 at the time of randomization.
• Abdominal surgery in the last 6 months prior to screening.
• A history of clinically significant intestinal adhesions increasing the risk of gastrointestinal obstruction.
• Severe constipation which is also not managed by dietary recommendations, laxatives or cathartic medications.
• Enterocutaneous fistula.
• History of cancer (including colon carcinoma) or clinically significant lymphoproliferative disease within ≤5 years, except for adequately treated basal cell skin cancer.
• History of cholecystitis or biliary obstruction, unless cholecystectomy was performed prior to screening to resolve the issues.
• Subjects with IBD who have NOT been on a stable drug treatment regimen for at least the previous 4 weeks prior to screening and randomization.
• Evidence of active IBD in the previous 12 weeks.
• Visible blood in the stool within the last 12 weeks.
• Central venous catheter sepsis experienced within the previous 8 weeks, prior to screening and randomization, or use of antibiotics within the last 30 days due to catheter infection.
• Decompensated heart failure (New York Heart Association class III–IV) [NYHA] and/or known coronary heart disease defined as unstable angina pectoris and/or myocardial infarction within the previous 6 months prior to Screening.
• Radiation enteritis, scleroderma or other condition of intestinal dysmotility, coeliac disease, refractory or tropical sprue.
• History of alcohol and/or drug abuse within the previous 12 months prior to screening.
• Child-Pugh scale Class C.
• Inadequate renal function as defined by creatinine clearance estimated by formula of Cockcroft-Gault at screening < 60 mL/min/1.73m^2.
• Unplanned hospitalization of > 24 hours duration within 4 weeks before Initial Screening and during Screening Period.
• Changes in systemic corticosteroids, methotrexate, cyclosporine, tacrolimus, sirolimus, infliximab, or other biologic therapy/immune modifiers within 30 days of Screening.
• Any previous use of growth factors such as native GLP-2, GLP-1, or GLP-2 or GLP-1 analogues in the previous 12 months before randomization for CIC subjects and 6 months for stoma subjects.
• Known or suspected hypersensitivity to GLP-1 or GLP-2 analogues or apraglutide excipients.
• Known neutralizing antibodies (nAB) against GLP-1 or GLP-2 analogues.
• Participation in another clinical trial within the last 12 weeks and during this trial (studies with catheter locks and non-interventional trials, which are not a burden on the subject and do not interfere with the participation in this trial, are excluded).
• Loss of blood or donation of blood or plasma >500 mL within 12 weeks prior to Screening.
• Positive results for human immunodeficiency virus, hepatitis A, B and/or C tests.*
• Subject not capable of understanding or not willing to adhere to the trial visit schedules and other protocol requirements.
• Judged not eligible by the Investigator for any other reason.
• * Subjects recovered from hepatitis A, B or C can be enrolled; i.e., they have markers of the infection, but the viral load is equal to zero. Subjects with evidence of an acute or chronically active hepatitis B or C infection should be excluded.