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NCT04775706PHASE2Recruiting

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

Hanmi Pharmaceutical Company Limited

Start Date

3/3/2022

Completion Date

5/1/2028

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).

Detailed Description

The study consists of a screening period, a run-in period, a 6-months core treatment period, a 7-months extension treatment period and a 1-month safety follow-up period.

Eligibility Criteria

Age Range: 18 years to No maximum

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)

Interventions

DRUG

HM15912 Active

DRUG

Placebo

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Conditions

Short Bowel Syndrome

Locations

Brigham & Women's Hospital

Boston, Massachusetts 02115

United States

The Cleveland Clinic Foundation

Cleveland, Ohio 44195

United States

UZ Leuven

Leuven, Vlaams Brabant 3000

Belgium

Rigshospitalet Department of Digestive Diseases, Transplantation and General Surgery Section for Intestinal Failure

Copenhagen, 2100

Denmark

Hopital Beaujon

Clichy, Clichy 92110

France

Centre Hospitalier Universitaire de Bordeaux

Bordeaux, 33000

France

Les Hospices Civils de Lyon

Lyon, 69002

France

Centre Hospitalier Universitaire de Nice

Nice, 06300

France

Asklepios Klinik St. Georg

Hamburg, Free and Hanseatic City of Hamburg 20099

Germany

Universitätsklinikum Tübingen

Tübingen, Tübingen 72076

Germany

Wojewodzki Specjalistyczny Szpital im. Mikołaja Pirogowa w Łodzi

Lodz, Łódź Voivodeship 90-531

Poland

Samsung Medical Center

Seoul, 06351

South Korea

Salford Royal Hospital

Salford, Greater Manchester M6 8HD

United Kingdom

Central Middlesex Hospital

London, NW10 7NS

United Kingdom