Phase 2 Study of Sonefpeglutide (HM15912) for Short Bowel Syndrome
This Phase 2 study is looking at a drug called sonefpeglutide (HM15912) for adults with Short Bowel Syndrome (SBS), a condition where your body can't absorb enough nutrients because part of your small intestine is missing or not working well. The main goal is to see how safe sonefpeglutide is by tracking any side effects over 24 weeks. You might be able to join if you are 18 or older and have SBS that causes intestinal failure. Some participants will receive sonefpeglutide, while others will receive a placebo (an inactive substance). The study is currently unclear about its recruitment status, but it plans to enroll 18 people.
- Study design
- This is a randomized, double-blind, placebo-controlled Phase 2 study, meaning participants are randomly assigned to receive either sonefpeglutide or a placebo, and neither you nor your doctor will know which you are receiving. The study plans to enroll 18 participants.
- What's involved
- The study involves a screening period, a run-in period, a 6-month core treatment period, a 7-month extension treatment period, and a 1-month safety follow-up period.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for safety for one month after the treatment period ends.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Phase 2 Study to Assess the Safety, PK, and PD of Sonefpeglutide (HM15912) in SBS-IF Subjects
At a glance
Conditions
NCT04775706
Where you'd take part
This study runs at 15 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Asklepios Klinik St. Georg
Hamburg, Free and Hanseatic City of Hamburg, Germanyno site contact published
Recruiting
Brigham & Women's Hospital
Boston, Massachusettsno site contact published
Recruiting
Central Middlesex Hospital
London, United Kingdomno site contact published
Recruiting
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, Franceno site contact published
Recruiting
Centre Hospitalier Universitaire de Nice
Nice, Franceno site contact published
Recruiting
Hopital Beaujon
Clichy, Clichy, Franceno site contact published
Recruiting
Les Hospices Civils de Lyon
Lyon, Franceno site contact published
Recruiting
Rigshospitalet Department of Digestive Diseases, Transplantation and General Surgery Section for Intestinal Failure
Copenhagen, Denmarkno site contact published
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Incidence of adverse events (AEs)for 24 weeks
after multiple subcutaneous (SC) doses