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New drug could help people with short bowel syndrome ditch IV nutrition

NCT ID NCT04775706

Disease control Sponsor: Hanmi Pharmaceutical Company Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 13, 2026 · Updated 3 times

Summary

This phase 2 trial tests a new drug called HM15912 (sonefpeglutide) in 18 adults with short bowel syndrome who need intravenous nutrition. The study aims to see if the drug is safe and can help the gut absorb more nutrients, potentially reducing the need for IV support. Participants are randomly assigned to receive either the drug or a placebo, and neither they nor their doctors know which they get.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HM15912 (sonefpeglutide)
What this could lead to
If it works, this could reduce or eliminate the need for intravenous nutrition in people with short bowel syndrome, improving their quality of life.
What could go wrong
This is a small, early-phase study with only 18 participants, so results may not apply to everyone. The drug may cause side effects or fail to show benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 18 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2022

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

short bowel syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Short bowel syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    15 sites in 8 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Asklepios Klinik St. Georg

    RECRUITING

    Hamburg, Free and Hanseatic City of Hamburg, 20099, Germany

  • Brigham & Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Central Middlesex Hospital

    RECRUITING

    London, NW10 7NS, United Kingdom

  • Centre Hospitalier Universitaire de Bordeaux

    RECRUITING

    Bordeaux, 33000, France

  • Centre Hospitalier Universitaire de Nice

    RECRUITING

    Nice, 06300, France

  • Hopital Beaujon

    RECRUITING

    Clichy, Clichy, 92110, France

  • Les Hospices Civils de Lyon

    RECRUITING

    Lyon, 69002, France

  • Rigshospitalet Department of Digestive Diseases, Transplantation and General Surgery Section for Intestinal Failure

    RECRUITING

    Copenhagen, 2100, Denmark

  • Salford Royal Hospital

    RECRUITING

    Salford, Greater Manchester, M6 8HD, United Kingdom

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

  • Szpital Skawina sp. z o.o.

    RECRUITING

    Skawina, Lesser Poland Voivodeship, 32-050, Poland

  • The Cleveland Clinic Foundation

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • UZ Leuven

    RECRUITING

    Leuven, Vlaams Brabant, 3000, Belgium

  • Universitätsklinikum Tübingen

    RECRUITING

    Tübingen, Tübingen, 72076, Germany

  • Wojewodzki Specjalistyczny Szpital im. Mikołaja Pirogowa w Łodzi

    RECRUITING

    Lodz, Łódź Voivodeship, 90-531, Poland

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