This is a randomized, double-blind, placebo-controlled, proof-of-concept (PoC), Phase 2 study to assess the safety, PK, and PD of SC administration of HM15912(sonefpeglutide) in adult subjects with SBS-associated intestinal failure (SBS-IF).
Men or women, aged 18 years of age or older with SBS resulting in intestinal failure at the time of signing the informed consent form (ICF) (or country's legal age of majority if the legal age is <18 years)
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
Diagnosis of SBS with the latest intestinal resection being at least 6 months prior to Screening and considered stable regarding the PN/IV need. No restorative surgery planned in the study period.
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 for at least 5 years
History of alcohol or drug abuse (within 1 year of screening)
Parallel
HM15912 Active
DrugRandomized, double-blind, placebo-controlled
Placebo
DrugRandomized, double-blind, placebo-controlled
Incidence of adverse events (AEs)
after multiple subcutaneous (SC) doses
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