NCT04775706 Phase 2 Study to Assess the Safety, PK, and PD of Sonefpeglutide (HM15912) in SBS-IF Subjects
| NCT ID | NCT04775706 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Hanmi Pharmaceutical Company Limited |
| Condition | Short Bowel Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2022-03-03 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 18 participants in total. It began in 2022-03-03 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 SBS-associated intestinal failure (SBS-IF).
Eligibility Criteria
Inclusion Criteria: 1. 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) 2. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol 3. 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 Criteria: 1. Any history of colon cancer. 2. 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 3. History of alcohol or drug abuse (within 1 year of screening)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04775706 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Short Bowel Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04775706 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04775706 currently recruiting?
Yes, NCT04775706 is actively recruiting participants. Contact the research team at wooyoung.hong@hanmi.co.kr for enrollment information.
Where is the NCT04775706 trial being conducted?
This trial is being conducted at Boston, United States, Cleveland, United States, Leuven, Belgium, Copenhagen, Denmark and 10 additional locations.
Who is sponsoring the NCT04775706 clinical trial?
NCT04775706 is sponsored by Hanmi Pharmaceutical Company Limited. The trial plans to enroll 18 participants.