Phase 2 Study to Assess the Safety, PK, and PD of Sonefpeglutide (HM15912) in SBS-IF Subjects
NCT ID: NCT04775706
Last Updated: 2025-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
18 participants
INTERVENTIONAL
2022-03-03
2028-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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HM15912 0.5 mg/kg, 1.0mg/kg, 1.5mg/kg Active
HM15912 Active
Randomized, double-blind, placebo-controlled
Matching Placebo
Placebo
Randomized, double-blind, placebo-controlled
Interventions
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HM15912 Active
Randomized, double-blind, placebo-controlled
Placebo
Randomized, double-blind, placebo-controlled
Eligibility Criteria
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Inclusion Criteria
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
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)
18 Years
ALL
No
Sponsors
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Hanmi Pharmaceutical Company Limited
INDUSTRY
Responsible Party
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Locations
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Brigham & Women's Hospital
Boston, Massachusetts, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
UZ Leuven
Leuven, Vlaams Brabant, Belgium
Rigshospitalet Department of Digestive Diseases, Transplantation and General Surgery Section for Intestinal Failure
Copenhagen, , Denmark
Hopital Beaujon
Clichy, Clichy, France
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, , France
Les Hospices Civils de Lyon
Lyon, , France
Centre Hospitalier Universitaire de Nice
Nice, , France
Asklepios Klinik St. Georg
Hamburg, Hamburg, Germany
Universitätsklinikum Tübingen
Tübingen, Tübingen, Germany
Wojewodzki Specjalistyczny Szpital im. Mikołaja Pirogowa w Łodzi
Lodz, Łódź Voivodeship, Poland
Samsung Medical Center
Seoul, , South Korea
Central Middlesex Hospital
London, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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DOLPHINS-2
Identifier Type: OTHER
Identifier Source: secondary_id
HM-GLP2-201
Identifier Type: -
Identifier Source: org_study_id
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