Phase 2 Study to Assess the Safety, PK, and PD in SBS-IF Subjects

Phase 2

Recruiting

• Conditions: Short Bowel Syndrome
• Interventions: Drug: HM15912 Active; Drug: Placebo

• Registration Number: NCT04775706
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief 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.

Study Timeline

• Study First Submitted: 2021-02-25
• Study First Submitted QC: 2021-02-26
• Study First Posted: 2021-03-01
• Study Start: 2022-03-03
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-12
• Primary Completion: 2027-12
• Study Completion: 2028-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 18

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HM15912 0.5 mg/kg, 1.0mg/kg, 1.5mg/kg Active	HM15912 Active	-
Matching Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events (AEs)	for 24 weeks	after multiple subcutaneous (SC) doses

Trial Locations

Locations (15)

University of Illinois Hospital & Health Sciences System (UI Health); 🇺🇸 Chicago, Illinois, United States

Brigham & Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

The Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

UZ Leuven; 🇧🇪 Leuven, Vlaams Brabant, Belgium

Aalborg Universitetshospital; 🇩🇰 Aalborg, Region Nordjylland, Denmark

Rigshospitalet Department of Digestive Diseases, Transplantation and General Surgery Section for Intestinal Failure; 🇩🇰 Copenhagen, Denmark

Centre Hospitalier Universitaire de Bordeaux; 🇫🇷 Bordeaux, France

Hopital Beaujon; 🇫🇷 Clichy, France

Les Hospices Civils de Lyon; 🇫🇷 Lyon, France

Centre Hospitalier Universitaire de Nice; 🇫🇷 Nice, France

Asklepios Klinik St. Georg; 🇩🇪 Hamburg, Germany

Universitätsklinikum Tübingen; 🇩🇪 Tübingen, Germany

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Uniwersytecki Szpital Kliniczny w Poznaniu Uniwersytecki Osrodek Wczesnych Faz Ul. Długa 1 /2; 🇵🇱 Poznań, Poznan, Poland

Wojewodzki Specjalistyczny Szpital im. Mikołaja Pirogowa w Łodzi; 🇵🇱 Lodz, Łódzkie, Poland