Phase 2 Study to Assess the Safety, PK, and PD of Sonefpeglutide (HM15912) in SBS-IF Subjects (NCT04775706)
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)
🩺 Plain-English Summary (8th-Grade Level)
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 join: Review the eligibility criteria below.
Location: Brigham & Women's Hospital — Boston, Massachusetts
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (15 Sites)
- Brigham & Women's Hospital — Boston, Massachusetts
- The Cleveland Clinic Foundation — Cleveland, Ohio
- UZ Leuven — Leuven, Vlaams Brabant
- Rigshospitalet Department of Digestive Diseases, Transplantation and General Surgery Section for Intestinal Failure — Copenhagen,
- Hopital Beaujon — Clichy, Clichy
- Centre Hospitalier Universitaire de Bordeaux — Bordeaux,
- Les Hospices Civils de Lyon — Lyon,
- Centre Hospitalier Universitaire de Nice — Nice,
- Asklepios Klinik St. Georg — Hamburg, Free and Hanseatic City of Hamburg
- Universitätsklinikum Tübingen — Tübingen, Tübingen
- Szpital Skawina sp. z o.o. — Skawina, Lesser Poland Voivodeship
- Wojewodzki Specjalistyczny Szpital im. Mikołaja Pirogowa w Łodzi — Lodz, Łódź Voivodeship
- Samsung Medical Center — Seoul,
- Salford Royal Hospital — Salford, Greater Manchester
- Central Middlesex Hospital — London,
📞 Contact the Study Coordinator
Phone: (822) 410-9238
Email: wooyoung.hong@hanmi.co.kr
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Short Bowel Syndrome
- Registry for Participants With Short Bowel Syndrome — Lexington, Massachusetts
- Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS — Washington D.C., District of Columbia
- Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS - Extension Trial — Washington D.C., District of Columbia
- Open-Label Pilot Study With Crofelemer in Patients With Short Bowel Syndrome — Cleveland, Ohio
- Open-label Extension Trial to Evaluate the Long-term Safety of Apraglutide in Short Bowel Syndrome. — Los Angeles, California
- A Feasibility Study to Evaluate Safety and Probable Benefit of the Eclipse XL1 System for Distraction Enterogenesis in Adult and Pediatric Patients With Short Bowel Syndrome — Palo Alto, California
Explore by condition: All Short Bowel Syndrome clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.