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

About

Brief Summary

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.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase III

Eligibility

Gender

All

Healthy Volunteers

Minimum Age

18 Years

Maximum Age

N/A

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.

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