Status:
RECRUITING
Phase 2 Study to Assess the Safety, PK, and PD of Sonefpeglutide (HM15912) in SBS-IF Subjects
Lead Sponsor:
Hanmi Pharmaceutical Company Limited
Conditions:
Short Bowel Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 SB...
Detailed Description
The study consists of a screening period, a run-in period, a 6-months core treatment period, a 7-months extension treatment period and a 1-month safety follow-up period.
Eligibility Criteria
Inclusion
- 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)
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
- 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
- Any history of colon cancer.
- 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
- History of alcohol or drug abuse (within 1 year of screening)
Key Trial Info
Start Date :
March 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2028
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04775706
Start Date
March 3 2022
End Date
May 1 2028
Last Update
December 11 2025
Active Locations (13)
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1
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
2
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
3
UZ Leuven
Leuven, Vlaams Brabant, Belgium, 3000
4
Rigshospitalet Department of Digestive Diseases, Transplantation and General Surgery Section for Intestinal Failure
Copenhagen, Denmark, 2100