Assessing a new treatment for Short Bowel Syndrome
A Multicenter, Proof-of-concept, Phase 2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HM15912 (Sonefpeglutide) in Adult Subjects With Short Bowel Syndrome-associated Intestinal Failure (SBS-IF)
PHASE2 · Hanmi Pharmaceutical Company Limited · NCT04775706
This study is testing a new treatment for adults with Short Bowel Syndrome to see if it can help improve their condition compared to a placebo.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hanmi Pharmaceutical Company Limited (industry) |
| Locations | 14 sites (Boston, Massachusetts and 13 other locations) |
| Trial ID | NCT04775706 on ClinicalTrials.gov |
What this trial studies
This Phase 2 clinical trial evaluates the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of HM15912 (sonefpeglutide) administered subcutaneously in adults with Short Bowel Syndrome associated with intestinal failure. The study includes a screening period, a run-in period, a core treatment phase lasting six months, followed by a seven-month extension treatment period, and concludes with a one-month safety follow-up. Participants will be randomly assigned to receive either the active treatment or a placebo in a double-blind manner.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of Short Bowel Syndrome resulting in intestinal failure, stable for at least six months post-surgery.
Not a fit: Patients with a history of colon cancer or other cancers (except certain skin cancers) may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve the management of Short Bowel Syndrome and enhance the quality of life for affected patients.
How similar studies have performed: Other studies have explored treatments for Short Bowel Syndrome, but this specific approach with HM15912 is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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) 2. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol 3. 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: 1. Any history of colon cancer. 2. 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 3. History of alcohol or drug abuse (within 1 year of screening)
Where this trial is running
Boston, Massachusetts and 13 other locations
- Brigham & Women's Hospital — Boston, Massachusetts, United States (RECRUITING)
- The Cleveland Clinic Foundation — Cleveland, Ohio, United States (RECRUITING)
- UZ Leuven — Leuven, Vlaams Brabant, Belgium (RECRUITING)
- Rigshospitalet Department of Digestive Diseases, Transplantation and General Surgery Section for Intestinal Failure — Copenhagen, Denmark (RECRUITING)
- Hopital Beaujon — Clichy, Clichy, France (RECRUITING)
- Centre Hospitalier Universitaire de Bordeaux — Bordeaux, France (RECRUITING)
- Les Hospices Civils de Lyon — Lyon, France (RECRUITING)
- Centre Hospitalier Universitaire de Nice — Nice, France (RECRUITING)
- Asklepios Klinik St. Georg — Hamburg, Free and Hanseatic City of Hamburg, Germany (RECRUITING)
- Universitätsklinikum Tübingen — Tübingen, Tübingen, Germany (RECRUITING)
- Wojewodzki Specjalistyczny Szpital im. Mikołaja Pirogowa w Łodzi — Lodz, Łódź Voivodeship, Poland (RECRUITING)
- Samsung Medical Center — Seoul, South Korea (RECRUITING)
- Salford Royal Hospital — Salford, Greater Manchester, United Kingdom (RECRUITING)
- Central Middlesex Hospital — London, United Kingdom (RECRUITING)
Study contacts
- Study coordinator: Wooyoung Amy Hong
- Email: wooyoung.hong@hanmi.co.kr
- Phone: +82 2 410 9238
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Short Bowel Syndrome