Open Actively Recruiting
Trial to Evaluate Efficacy and Safety of Apraglutide in SBS-IF
The primary objective of the trial is the confirmation of the efficacy of apraglutide to evaluate the efficacy of weekly subcutaneous apraglutide in reducing parenteral support dependency.
- 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.
- 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.
Join this Trial
Contact our clinical trial navigators for opportunities that may be suitable for you