Phase 2 Study to Assess the Safety, PK, and PD of Sonefpeglutide (HM15912) in SBS-IF Subjects
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Short Bowel Syndrome
In brief
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).
Key facts
- Study ID
- NCT04775706
- Run by
- Hanmi Pharmaceutical Company Limited
- People needed
- 18
- Starts
- 2022-03-03
- Expected to finish
- 2028-05-01
- Last updated by the study team
- 2026-04-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify 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.
You may not qualify if…
- 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)
Where it is running
- Brigham & Women's Hospital — Boston, Massachusetts, United States (enrolling)
- The Cleveland Clinic Foundation — Cleveland, Ohio, United States (enrolling)
- UZ Leuven — Leuven, Vlaams Brabant, Belgium (enrolling)
- Rigshospitalet Department of Digestive Diseases, Transplantation and General Surgery Section for Intestinal Failure — Copenhagen, Denmark (enrolling)
- Hopital Beaujon — Clichy, Clichy, France (enrolling)
- Centre Hospitalier Universitaire de Bordeaux — Bordeaux, France (enrolling)
- Les Hospices Civils de Lyon — Lyon, France (enrolling)
- Centre Hospitalier Universitaire de Nice — Nice, France (enrolling)
- Asklepios Klinik St. Georg — Hamburg, Free and Hanseatic City of Hamburg, Germany (enrolling)
- Universitätsklinikum Tübingen — Tübingen, Tübingen, Germany (enrolling)
- Wojewodzki Specjalistyczny Szpital im. Mikołaja Pirogowa w Łodzi — Lodz, Łódź Voivodeship, Poland (enrolling)
- Samsung Medical Center — Seoul, South Korea (enrolling)
- Salford Royal Hospital — Salford, Greater Manchester, United Kingdom (enrolling)
- Central Middlesex Hospital — London, United Kingdom (enrolling)
Full record on ClinicalTrials.gov
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