RecruitingPhase 2

Phase 2 Study to Assess the Safety, PK, and PD of Sonefpeglutide (HM15912) in SBS-IF Subjects

United States, Belgium, Denmark18 participantsStarted 2022-03-03

Plain-language summary

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).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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)

What they're measuring

Incidence of adverse events (AEs)

Timeframe: for 24 weeks

Trial details

NCT IDNCT04775706

SponsorHanmi Pharmaceutical Company Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12

Contact for this trial

Wooyoung Amy Hong

+82 2 410 9238 wooyoung.hong@hanmi.co.kr

View on ClinicalTrials.gov More Short Bowel Syndrome trials