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)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04775706

Enrollment

Registered

2021-03-01

Start date

2022-03-03

Completion date

2028-05-01

Last updated

2026-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Short Bowel Syndrome

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).

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.

Interventions

DRUGHM15912 Active

Randomized, double-blind, placebo-controlled

DRUGPlacebo

Randomized, double-blind, placebo-controlled

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Incidence of adverse events (AEs)	for 24 weeks	after multiple subcutaneous (SC) doses

Countries

Belgium, Denmark, France, Germany, Poland, South Korea, United Kingdom, United States

Contacts

CONTACTWooyoung Amy Hong

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 13, 2026