Actively Recruiting
Phase 2 Study to Assess the Safety, PK, and PD of Sonefpeglutide (HM15912) in SBS-IF Subjects
Led by Hanmi Pharmaceutical Company Limited · Updated on 2026-04-28
18
Participants Needed
14
Research Sites
321 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Phase 2 Study to Assess the Safety, PK, and PD of Sonefpeglutide (HM15912) in SBS-IF Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women aged 18 years or older with short bowel syndrome causing intestinal failure
- Able to provide signed informed consent and comply with study requirements
- Diagnosis of short bowel syndrome with the latest intestinal surgery at least 6 months before screening and stable nutritional support needs
- No planned restorative surgery during the study period
You will not qualify if you...
- History of colon cancer
- History of any other cancers unless disease-free for at least 5 years, except treated skin or cervical cancers
- History of alcohol or drug abuse within 1 year before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
2
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
3
UZ Leuven
Leuven, Vlaams Brabant, Belgium, 3000
Actively Recruiting
4
Rigshospitalet Department of Digestive Diseases, Transplantation and General Surgery Section for Intestinal Failure
Copenhagen, Denmark, 2100
Actively Recruiting
5
Hopital Beaujon
Clichy, Clichy, France, 92110
Actively Recruiting
6
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, France, 33000
Actively Recruiting
7
Les Hospices Civils de Lyon
Lyon, France, 69002
Actively Recruiting
8
Centre Hospitalier Universitaire de Nice
Nice, France, 06300
Actively Recruiting
9
Asklepios Klinik St. Georg
Hamburg, Free and Hanseatic City of Hamburg, Germany, 20099
Actively Recruiting
10
Universitätsklinikum Tübingen
Tübingen, Tübingen, Germany, 72076
Actively Recruiting
11
Wojewodzki Specjalistyczny Szpital im. Mikołaja Pirogowa w Łodzi
Lodz, Łódź Voivodeship, Poland, 90-531
Actively Recruiting
12
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
13
Salford Royal Hospital
Salford, Greater Manchester, United Kingdom, M6 8HD
Actively Recruiting
14
Central Middlesex Hospital
London, United Kingdom, NW10 7NS
Actively Recruiting
Research Team
W
Wooyoung Amy Hong
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here