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Clinical Trials in South Korea / NCT04775706
Recruiting Phase 2

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

NCT04775706 · tracked via the Priya Life Science South Korea 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
No
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)

FacilityCityRegionStatus
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 South Korea

A Study to Evaluate Efficacy and Safety of HCP1803-4 in Patients With Essential Hypertension Starting soon
A Study to Evaluate Efficacy and Safety of HM11260C in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin and Dapagliflozin Recruiting
A Study to Evaluate the Pharmacokinetics and Safety Between HIP2503 and HCP1306 in Healthy Volunteers Starting soon
HM15136 (Efpegerglucagon) Treatment for 8 Weeks in Subjects Aged ≥2 Years With Congenital Hyperinsulinism (CHI) Active, not recruiting
Dose Escalation and Expansion Study of HM97662 in Advanced or Metastatic Solid Tumors Active, not recruiting

Other trials for the same condition

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 South Korea