RecruitingPhase 2NCT04775706

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

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

Enrollment

18 participants

Start Date

Mar 3, 2022

Study Type

INTERVENTIONAL

Conditions

Short Bowel Syndrome

Summary

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called HM15912 Active and a drug called Placebo for people with short bowel syndrome. The study is currently recruiting participants at 14 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHM15912 Active

Randomized, double-blind, placebo-controlled

DRUGPlacebo

Randomized, double-blind, placebo-controlled

Locations(14)

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, Free and Hanseatic City of 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

Salford Royal Hospital

Salford, Greater Manchester, United Kingdom

Central Middlesex Hospital

London, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT04775706

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