CClinicalTrials.gg
RecruitingNCT04775706Updated Aug 12, 2026

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

A Phase 2 interventional study of HM15912 Active and Placebo in Short Bowel Syndrome, sponsored by Hanmi Pharmaceutical Company Limited. Recruiting at 15 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-12.

Sponsored by Hanmi Pharmaceutical Company Limited · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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).

Read the 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.

02

Conditions studied

  • Short Bowel Syndrome

Browse trials for

03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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)
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
18 participants (estimated)

Study arms

  • Experimental
    HM15912 0.5 mg/kg, 1.0mg/kg, 1.5mg/kg Active

    Drug: HM15912 Active

  • Placebo comparator
    Matching Placebo

    Drug: Placebo

Interventions

  • DrugHM15912 Active

    Randomized, double-blind, placebo-controlled

  • DrugPlacebo

    Randomized, double-blind, placebo-controlled

05

What researchers measure

Primary outcomes

  1. Incidence of adverse events (AEs)

    after multiple subcutaneous (SC) doses

    Time frame: for 24 weeks

06

Study locations

15 of 15 sites recruiting
  • Brigham & Women's Hospital
    Boston, Massachusetts 02115, United States
    Recruiting
  • The Cleveland Clinic Foundation
    Cleveland, Ohio 44195, United States
    Recruiting
  • UZ Leuven
    Leuven, Vlaams Brabant 3000, Belgium
    Recruiting
  • Rigshospitalet Department of Digestive Diseases, Transplantation and General Surgery Section for Intestinal Failure
    Copenhagen, 2100, Denmark
    Recruiting
  • Hopital Beaujon
    Clichy, Clichy 92110, France
    Recruiting
  • Centre Hospitalier Universitaire de Bordeaux
    Bordeaux, 33000, France
    Recruiting
  • Les Hospices Civils de Lyon
    Lyon, 69002, France
    Recruiting
  • Centre Hospitalier Universitaire de Nice
    Nice, 06300, France
    Recruiting
  • Asklepios Klinik St. Georg
    Hamburg, Free and Hanseatic City of Hamburg 20099, Germany
    Recruiting
  • Universitätsklinikum Tübingen
    Tübingen, Tübingen 72076, Germany
    Recruiting
  • Szpital Skawina sp. z o.o.
    Skawina, Lesser Poland Voivodeship 32-050, Poland
    Recruiting
  • Wojewodzki Specjalistyczny Szpital im. Mikołaja Pirogowa w Łodzi
    Lodz, Łódź Voivodeship 90-531, Poland
    Recruiting
  • Samsung Medical Center
    Seoul, 06351, South Korea
    Recruiting
  • Salford Royal Hospital
    Salford, Greater Manchester M6 8HD, United Kingdom
    Recruiting
  • Central Middlesex Hospital
    London, NW10 7NS, United Kingdom
    Recruiting
07

Registry details

Key details

Study ID
NCT04775706
Lead sponsor
Hanmi Pharmaceutical Company Limited
Responsible party
Sponsor
First posted
Mar 1, 2021
Start date
Mar 3, 2022
Primary completion
Dec 2027 (estimated)
Completion
May 2028 (estimated)
Last update
Aug 12, 2026

Study contacts

Wooyoung Amy Hong
Contact
wooyoung.hong@hanmi.co.kr
+82 2 410 9238

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion