Trial to Evaluate Efficacy and Safety of Apraglutide in SBS-IF

This is an international, multicenter, double-blind, randomized, placebo-controlled, trial to evaluate the efficacy and safety of weekly SC injections of apraglutide in adult subjects with SBS-IF. The active pharmaceutical ingredient is apraglutide, a GLP-2 analogue.

The trial consists of a screening phase, a treatment phase of 48 weeks, and a safety follow-up phase. Trial participants will receive, after successful screening, once weekly apraglutide.

Inclusion criteria

• Signed informed consent for this trial prior to any trial specific assessment.
• Male and female subjects with SBS-IF, receiving parenteral support (PS), secondary to surgical resection of the small intestine with either stoma or colon-in-continuity (CIC).
• Subject must require PS at least 3 days per work and be considered stable.
• No restorative surgery intended to change PS requirements in the trial period.
• Age ≥18 years at screening.

Exclusion criteria

• Pregnancy or lactation.
• Major abdominal surgery in the last 6 months prior to screening.
• History of cancer (including colon carcinoma) or clinically significant lymphoproliferative disease within ≤5 years, except for adequately treated basal cell skin cancer.
• Evidence of active inflammatory GI conditions in the previous 6 months.
• Evidence of decompensated heart failure.
• Evidence of severe renal or hepatic impairment.
• Any previous use of growth factors such as growth hormone (GH), native GLP-2, GLP-1, or GLP-2 or GLP-1 analogues should be discussed with the Investigator.