What this study is
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).
What's being tested
- HM15912 Active
Intervention · DRUG
- Placebo
Intervention · DRUG
Both interventions
Randomized, double-blind, placebo-controlled
Study details
- 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)
- Sponsor
- Hanmi Pharmaceutical Company Limited
- Conditions
- Short Bowel Syndrome
- Enrolling
- 18 people
- Starts
- 2022-03-03
- Est. completion
- 2028-05
- Design
- Double-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (15)
15 openBrigham & Women's Hospital
Boston, Massachusetts, United States
RecruitingThe Cleveland Clinic Foundation
Cleveland, Ohio, United States
Recruiting
13 sites outside the US
UZ Leuven
Leuven, Vlaams Brabant, Belgium
RecruitingRigshospitalet Department of Digestive Diseases, Transplantation and General Surgery Section for Intestinal Failure
Copenhagen, Denmark
RecruitingHopital Beaujon
Clichy, Clichy, France
RecruitingCentre Hospitalier Universitaire de Bordeaux
Bordeaux, France
RecruitingLes Hospices Civils de Lyon
Lyon, France
RecruitingCentre Hospitalier Universitaire de Nice
Nice, France
RecruitingAsklepios Klinik St. Georg
Hamburg, Free and Hanseatic City of Hamburg, Germany
RecruitingUniversitätsklinikum Tübingen
Tübingen, Tübingen, Germany
RecruitingSzpital Skawina sp. z o.o.
Skawina, Lesser Poland Voivodeship, Poland
RecruitingWojewodzki Specjalistyczny Szpital im. Mikołaja Pirogowa w Łodzi
Lodz, Łódź Voivodeship, Poland
RecruitingSamsung Medical Center
Seoul, South Korea
RecruitingSalford Royal Hospital
Salford, Greater Manchester, United Kingdom
RecruitingCentral Middlesex Hospital
London, United Kingdom
Recruiting
Study team
Sponsor
Hanmi Pharmaceutical Company Limited
Study ID HM-GLP2-201
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.