Recruiting
Phase 2

SBS-IF

Sponsor:

Hanmi Pharmaceutical Company Limited

Code:

NCT04775706

Conditions

Short Bowel Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

HM15912 Active

Placebo

Study Details

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).

Conditions

Short Bowel Syndrome

Study ID

NCT04775706

Start date

Mar 3, 2022

Status verified date

Apr, 2026

Completion date

May, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

18 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: HM15912 0.5 mg/kg, 1.0mg/kg, 1.5mg/kg Active

placebo comparator: Matching Placebo

Interventions

HM15912 Active

Randomized, double-blind, placebo-controlled

Placebo

Randomized, double-blind, placebo-controlled

Primary outcome measure

  • Incidence of adverse events (AEs) [ Time Frame: for 24 weeks ]

Central Contacts and Locations

Central contacts

Wooyoung Amy Hong

+82 2 410 9238wooyoung.hong@hanmi.co.kr

Locations

Brigham & Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

The Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

More Information

Sponsor

Hanmi Pharmaceutical Company Limited

Last update posted

Aug 12, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hanmi Pharmaceutical Company Limited on 2026-08-12.