Recruiting
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)
What is being tested
HM15912 Active
+ Placebo
Drug
Who is being recruted
Digestive System Diseases+5
+ Gastrointestinal Diseases
+ Intestinal Diseases
Over 18 Years
+6 Eligibility Criteria
How is the trial designed
Treatment Study
Placebo-ControlledPhase 2
Interventional
Study Start: March 2022
Summary
Principal SponsorHanmi Pharmaceutical Company Limited
Study ContactWooyoung Amy Hong
Last updated: January 28, 2026Sourced from a government-validated database.Claim as a partner
Study start date: March 3, 2022
Actual date on which the first participant was enrolled.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.
Official TitleA 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)
Principal SponsorHanmi Pharmaceutical Company Limited
Study ContactWooyoung Amy Hong
Last updated: January 28, 2026Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
18 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Digestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesMalabsorption SyndromesPathologic ProcessesPostoperative ComplicationsShort Bowel SyndromePathological Conditions, Signs and Symptoms
Criteria
3 inclusion criteria required to participate
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)
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
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.
3 exclusion criteria prevent from participating
Any history of colon cancer.
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
History of alcohol or drug abuse (within 1 year of screening)
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 13 locations
Recruiting
Recruiting
The Cleveland Clinic Foundation
Cleveland, United StatesRecruiting
UZ Leuven
Leuven, BelgiumRecruiting
Rigshospitalet Department of Digestive Diseases, Transplantation and General Surgery Section for Intestinal Failure
Copenhagen, DenmarkRecruiting
13 Study Centers