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Phase 2 Study to Assess the Safety, PK, and PD of Sonefpeglutide (HM15912) in SBS-IF Subjects

RecruitingPhase 2Ages 18 Years - anyAllHanmi Pharmaceutical Company Limited
NCT04775706 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
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)
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What it tests

  • HM15912 Active
  • Placebo
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Where

15 sites
Brigham & Women's Hospital
Boston, United States
The Cleveland Clinic Foundation
Cleveland, United States
UZ Leuven
Leuven, Belgium
Rigshospitalet Department of Digestive Diseases, Transplantation and General Surgery Section for Intestinal Failure
Copenhagen, Denmark
Hopital Beaujon
Clichy, France
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, France
Les Hospices Civils de Lyon
Lyon, France
Centre Hospitalier Universitaire de Nice
Nice, France

…and 7 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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