A Phase 2 interventional study of HM15912 Active and Placebo in Short Bowel Syndrome, sponsored by Hanmi Pharmaceutical Company Limited. Recruiting at 15 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Hanmi Pharmaceutical Company Limited · Phase 2, Interventional, and Treatment
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).
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.
159 studies on the registry are indexed under Short Bowel Syndrome; 24 are open to participants now.
This study's planned enrollment of 18 is below the median of 21 across 108 interventional studies indexed under Short Bowel Syndrome.
Browse Short Bowel Syndrome studies →Hanmi Pharmaceutical Company Limited is the lead sponsor of 190 studies on the registry; 11 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 6 (55%) have results posted.
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Exclusion Criteria:
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: HM15912 Active
Drug: Placebo
Randomized, double-blind, placebo-controlled
Randomized, double-blind, placebo-controlled
Incidence of adverse events (AEs)
after multiple subcutaneous (SC) doses
Time frame: for 24 weeks
Started Mar 2022 (actual). Primary completion is estimated for Dec 2027, 69 months after the start.
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Studies of the drug tested here: HM15912
Hanmi Pharmaceutical Company Limited →