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

NCT04775706 · tracked via the Priya Life Science USA tracker

Sponsor

Hanmi Pharmaceutical Company Limited

Phase

Phase 2

Started

2022-03-03

Last updated

2026-08-12

Condition(s) studied

Short Bowel Syndrome

Investigational drug(s) / intervention(s)

HM15912 ActivePlacebo

HM15912 Active: Randomized, double-blind, placebo-controlled

Placebo: Randomized, double-blind, placebo-controlled

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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)

Primary outcome measure(s)

Incidence of adverse events (AEs) — for 24 weeks
after multiple subcutaneous (SC) doses

Trial sites (15)

Facility	City	Region	Status
Brigham & Women's Hospital	Boston	Massachusetts	Recruiting
The Cleveland Clinic Foundation	Cleveland	Ohio	Recruiting
UZ Leuven	Leuven	Vlaams Brabant	Recruiting
Rigshospitalet Department of Digestive Diseases, Transplantation and General Surgery Section for Intestinal Failure	Copenhagen	Denmark	Recruiting
Hopital Beaujon	Clichy	Clichy	Recruiting
Centre Hospitalier Universitaire de Bordeaux	Bordeaux	France	Recruiting
Les Hospices Civils de Lyon	Lyon	France	Recruiting
Centre Hospitalier Universitaire de Nice	Nice	France	Recruiting
Asklepios Klinik St. Georg	Hamburg	Free and Hanseatic City of Hamburg	Recruiting
Universitätsklinikum Tübingen	Tübingen	Tübingen	Recruiting
Szpital Skawina sp. z o.o.	Skawina	Lesser Poland Voivodeship	Recruiting
Wojewodzki Specjalistyczny Szpital im. Mikołaja Pirogowa w Łodzi	Lodz	Łódź Voivodeship	Recruiting
Samsung Medical Center	Seoul	South Korea	Recruiting
Salford Royal Hospital	Salford	Greater Manchester	Recruiting
Central Middlesex Hospital	London	United Kingdom	Recruiting

More Hanmi Pharmaceutical Company Limited trials in the USA

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Dose Escalation and Expansion Study of HM16390 Alone or With Pembrolizumab in Advanced or Metastatic Solid Tumors Recruiting

Study to Evaluate HM15275 in Subjects With Type 2 Diabetes Mellitus Recruiting

Dose Escalation and Expansion Study of BH3120 Alone or With Pembrolizuamb in Advanced or Metastatic Solid Tumors Recruiting

Other trials for the same condition

Registry for Participants With Short Bowel Syndrome Active, not recruiting

Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS Recruiting

Open-label Extension Trial to Evaluate the Long-term Safety of Apraglutide in Short Bowel Syndrome. Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04775706 on ClinicalTrials.gov ↗ ← All trials in the USA