ClinicalTrials.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

From the registry’s dates

  • Started Mar 2022; still recruiting 4 years 8 months later.
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

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03

In context

Short Bowel Syndrome

159 studies on the registry are indexed under Short Bowel Syndrome; 24 are open to participants now.

This study's planned enrollment of 18 is below the median of 21 across 108 interventional studies indexed under Short Bowel Syndrome.

Browse Short Bowel Syndrome studies →

Lead sponsor

Hanmi Pharmaceutical Company Limited is the lead sponsor of 190 studies on the registry; 11 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 6 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

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

  • Randomized, double-blind, placebo-controlled

  • DrugPlacebo

    Randomized, double-blind, placebo-controlled

06

What researchers measure

Primary outcomes

  1. Incidence of adverse events (AEs)

    after multiple subcutaneous (SC) doses

    Time frame: for 24 weeks

07

Study locations

15 of 15 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2022 (actual). Primary completion is estimated for Dec 2027, 69 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 25, 2021
First posted
Mar 1, 2021
StartActual
Mar 3, 2022
Primary completionEst.
Dec 2027
CompletionEst.
May 2028
Last update
Aug 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04775706
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 ↗

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