DOLPHINS-2
Research type
Research Study
Full title
A Multicenter, Proof of concept, Phase 2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HM15912 in Adult Subjects with Short Bowel Syndrome associated Intestinal Failure (SBS IF) (DOLPHINS-2)
IRAS ID
1011644
Contact name
Moon Hee Lee
Contact email
Sponsor organisation
Hanmi Pharmaceutical Co., Ltd.
Clinicaltrials.gov Identifier
Research summary
Short bowel syndrome (SBS) is a condition in which the small intestine does not have adequate surface area or length to absorb enough nutrients.
Currently, there is no cure for SBS, and people with very short intestine are likely to remain totally dependent on parenteral nutrition/intravenous (PN/IV) fluid. However, prolonged use of PN/IV may lead to serious, life-threatening complications, including sepsis, osteopenia, and chronic liver disease.
To reduce PN/IV dependency, GLP-2 was suggested as a form of therapy. GLP-2 is a key hormone that affects intestinal function. Currently, teduglutide (Gattex®/Revestive®) is the only marketed drug of GLP-2 analogue for SBS. However, it is only available in some countries and has a short duration of action and limited stability in the human body. To overcome the limitations of teduglutide, the Sponsor has developed the study drug HM15912 (Sonefpeglutide), a novel long-acting GLP-2 analogue, to prolong its duration of action for the treatment for SBS. This study will mainly evaluate whether the study drug is safe and tolerable for use in patients diagnosed as short bowel syndrome-associated intestinal failure (SBS-IF) with jejunostomy or ileostomy.
There will be 18 patients participating in this study, that will be conducted at study sites in the United States, France, Poland, Germany, Belgium, Denmark, UK and South Korea. This study will be conducted approximately in 15 study sites.
The Sponsor Name is Hanmi Pharmaceutical Co., Ltd.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
25/NE/0136
Date of REC Opinion
21 Aug 2025
REC opinion
Further Information Favourable Opinion