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

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)

Who can join

Ages 18 and older · All sexes

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)

About the study

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).

What is being tested

• HM15912 Active (drug)
• Placebo (drug)

Sponsor: Hanmi Pharmaceutical Company Limited · Participants: 18 · Started: Mar 3, 2022

Contact the study team

• Wooyoung Amy Hong · Phone: +82 2 410 9238

Official record on ClinicalTrials.gov — NCT04775706

Locations in the U.S.

Conditions

• Short Bowel Syndrome

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.