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Clinical trial Recruiting at 15 sites Phase 2 Interventional Ages 18 and up

Assessing a new treatment for Short Bowel Syndrome

Official title: A Multicenter, Proof-of-concept, Phase 2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HM15912 (Sonefpeglutide) in Adult Subjects With Short Bowel Syndrome-associated Intestinal Failure (SBS-IF)

Run by Hanmi Pharmaceutical Company Limited · NCT04775706 · Data updated 2026-11-12

This study is testing a new treatment for adults with Short Bowel Syndrome to see if it can help improve their condition compared to a placebo.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment18 (estimated)
SponsorHanmi Pharmaceutical Company Limited
Industry-sponsored
Locations15 sites (Boston, Massachusetts and 14 other locations)
StatusRecruiting
StartedMarch 3, 2022
Main results expectedDecember 2027
Study endsMay 2028
Registry record updatedAugust 12, 2026
Trial IDNCT04775706 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 and older with a diagnosis of Short Bowel Syndrome resulting in intestinal failure, stable for at least six months post-surgery.

Probably not a fit

Patients with a history of colon cancer or other cancers (except certain skin cancers) may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 clinical trial evaluates the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of HM15912 (sonefpeglutide) administered subcutaneously in adults with Short Bowel Syndrome associated with intestinal failure. The study includes a screening period, a run-in period, a core treatment phase lasting six months, followed by a seven-month extension treatment period, and concludes with a one-month safety follow-up. Participants will be randomly assigned to receive either the active treatment or a placebo in a double-blind manner.

Why it matters

Potential benefit: If successful, this treatment could improve the management of Short Bowel Syndrome and enhance the quality of life for affected patients.

How similar studies have gone: Other studies have explored treatments for Short Bowel Syndrome, but this specific approach with HM15912 is novel.

Who can join: the full rules

Show full inclusion / exclusion 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)

Where it's running

  • Brigham & Women's Hospital
    Boston, Massachusetts, United States     Recruiting
  • The Cleveland Clinic Foundation
    Cleveland, Ohio, United States     Recruiting
  • UZ Leuven
    Leuven, Vlaams Brabant, Belgium     Recruiting
  • Rigshospitalet Department of Digestive Diseases, Transplantation and General Surgery Section for Intestinal Failure
    Copenhagen, Denmark     Recruiting
  • Hopital Beaujon
    Clichy, Clichy, France     Recruiting
  • Centre Hospitalier Universitaire de Bordeaux
    Bordeaux, France     Recruiting
Show 9 more locations
  • Les Hospices Civils de Lyon
    Lyon, France     Recruiting
  • Centre Hospitalier Universitaire de Nice
    Nice, France     Recruiting
  • Asklepios Klinik St. Georg
    Hamburg, Free and Hanseatic City of Hamburg, Germany     Recruiting
  • Universitätsklinikum Tübingen
    Tübingen, Tübingen, Germany     Recruiting
  • Szpital Skawina sp. z o.o.
    Skawina, Lesser Poland Voivodeship, Poland     Recruiting
  • Wojewodzki Specjalistyczny Szpital im. Mikołaja Pirogowa w Łodzi
    Lodz, Łódź Voivodeship, Poland     Recruiting
  • Samsung Medical Center
    Seoul, South Korea     Recruiting
  • Salford Royal Hospital
    Salford, Greater Manchester, United Kingdom     Recruiting
  • Central Middlesex Hospital
    London, United Kingdom     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.