Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

RecruitingRare disease

Study of HM15912 for Adults with Short Bowel Syndrome-associated Intestinal Failure

Fast replyInvestigationalNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as Short Bowel Syndrome-associated Intestinal Failure (SBS-IF). This condition occurs when a significant portion of the small intestine is missing or not functioning properly, leading to difficulties in absorbing nutrients. The trial will evaluate a treatment called HM15912, which is a special type of protein designed to help improve the condition. This protein is a human glucagon-like peptide-2 analogue linked to a human immunoglobulin FC fragment, and it is administered as a solution for injection using a pre-filled syringe.

The purpose of the study is to assess the safety and tolerability of HM15912 when given through multiple subcutaneous injections over a period of 24 weeks. Participants will receive these injections under the skin, and the study will monitor how the body processes the medication, which is known as its pharmacokinetic profile. The trial will also look at how the treatment affects the need for parenteral nutrition or intravenous fluids, which are methods of providing nutrition directly into the bloodstream.

Throughout the study, participants will be closely monitored for any side effects or reactions at the injection site. The trial will also include regular checks of vital signs, such as heart rate and blood pressure, and may involve tests like a 12-lead electrocardiogram (ECG) to ensure the treatment is safe. The study aims to provide valuable information on how HM15912 can help manage Short Bowel Syndrome-associated Intestinal Failure and improve the quality of life for those affected by this condition.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria, such as age, medical history, and current health status related to Short Bowel Syndrome-associated Intestinal Failure (SBS-IF).

  2. Step 2

    Initial assessment

    An initial assessment is conducted to establish baseline health metrics. This includes physical examinations, laboratory tests, and possibly an electrocardiogram (ECG).

  3. Step 3

    Medication administration

    The medication, HM15912, is administered as a solution for injection using a pre-filled syringe. The injection is given subcutaneously, which means it is injected under the skin.

    The treatment involves multiple doses over a period of 24 weeks.

  4. Step 4

    Monitoring and follow-up

    Throughout the 24-week period, regular monitoring is conducted to assess safety and tolerability. This includes tracking any adverse events, injection site reactions, and changes in laboratory results.

    Vital signs and ECG parameters are also monitored for any significant changes.

  5. Step 5

    Pharmacokinetic assessment

    The study evaluates how the body processes the medication, including measuring the maximum serum concentration, time to reach maximum concentration, and how long the medication stays in the body.

  6. Step 6

    Evaluation of treatment effects

    The study assesses changes in the volume of parenteral nutrition or intravenous fluids required from the start of the study to week 25.

  7. Step 7

    Completion of the study

    Upon completion of the 24-week treatment period, a final assessment is conducted to evaluate overall health and any changes in the condition.

Who can join the trial?

12 criteria

  • Men or women, aged 18 years or older, with **Short Bowel Syndrome** leading to **intestinal failure** at the time of signing the consent form.
  • If you have previously been treated with a **GLP-2 analog** (a type of medication), you can join if you stopped using it at least 3 months before the study and are willing to share your medical history.
  • Sexually active women who can have children must use approved birth control methods during the study and for 60 days after the last dose of the study drug.
  • Sexually active men must use approved birth control methods during the study and for 60 days after the last dose of the study drug.
  • Must be able to give signed consent and agree to follow the study's rules and requirements.
  • Must have a diagnosis of **Short Bowel Syndrome** with the last intestinal surgery at least 6 months before the study and no planned surgeries during the study.
  • Must have stable **Parenteral Nutrition (PN)** or **Intravenous (IV)** nutrition, with less than a 25% change in volume and energy in the 4 weeks before the study.
  • Must be willing to follow a specific 24-hour drinking plan during certain data collection periods.
  • If you have a remaining part of the colon, you must not have colon polyps or have had them removed within 6 months before the study.
  • If you have a **jejunostomy** or **ileostomy** (types of surgical openings in the abdomen), you must be able to separate stool and urine during the data collection period.
  • Must weigh at least 30 kg and have a **Body Mass Index (BMI)** greater than 18 kg/m².
  • Must have a stable body weight in the 6 months before the study, with only small changes allowed.

Who cannot join the trial?

10 criteria

  • Patients who have a history of severe allergic reactions to any of the ingredients in the study medication.
  • Patients who are currently participating in another clinical trial or have participated in one within the last 30 days.
  • Patients with a history of drug or alcohol abuse within the past year.
  • Patients who have any other medical condition that the study doctors believe would make it unsafe for them to participate.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had a major surgery within the last 3 months.
  • Patients with uncontrolled high blood pressure or diabetes.
  • Patients who have an active infection that requires treatment with antibiotics.
  • Patients who have a history of cancer within the last 5 years, except for certain types of skin cancer.
  • Patients who have a history of heart attack or stroke within the last 6 months.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

HM15912 is an investigational medication being studied for its potential benefits in adults with Short Bowel Syndrome-associated Intestinal Failure (SBS-IF). This medication is administered through injections under the skin. The trial aims to evaluate how safe and well-tolerated HM15912 is when given over a period of 24 weeks. Additionally, the study will look at how the body processes the medication, which is known as its pharmacokinetic profile.

What is already known about the treatment

HM15912 – This medication is administered through subcutaneous injections and is currently being studied in clinical trials for its safety and effectiveness. It is primarily being investigated for the treatment of Short Bowel Syndrome-associated Intestinal Failure (SBS-IF). The drug works by influencing specific biological pathways to improve nutrient absorption and intestinal function. It falls under the pharmacological classification of treatments for gastrointestinal disorders.

Investigated diseases

Short Bowel Syndrome-associated Intestinal Failure (SBS-IF) – This condition occurs when a significant portion of the small intestine is missing or not functioning properly, leading to an inability to absorb enough nutrients and fluids. It often results from surgical removal of parts of the intestine due to disease or injury. Individuals with SBS-IF may experience severe diarrhea, dehydration, and malnutrition. The body struggles to maintain adequate levels of essential vitamins, minerals, and electrolytes. Over time, the condition can lead to complications such as kidney stones, gallstones, and bacterial overgrowth in the intestines. Management often involves nutritional support, including parenteral nutrition, to ensure the body receives necessary nutrients.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515160-32-00Protocol codeHM-GLP2-201Estimated enrolment18 patientsSponsorHanmi Pharm. Co. Ltd.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).