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

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What is this study about?

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.

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 initial assessment

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

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Hopital Beaujon	Clichy	France
Asklepios Klinik St George	Hamburg	Germany
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Aalborg University Hospital	Aalborg	Denmark
Centre Hospitalier Universitaire De Nice	Nice	France
Rigshospitalet	Copenhagen	Denmark
Centre Hospitalier Lyon Sud	Pierre Benite	France
Wamntyiuxj Slqxxkexfbrqpjj Sfskams Isz Mg Pznrjwon W Louer	Lodz	Poland
Skqmaop Skctbkk Ssi z obgr	Skawina	Poland

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	26.10.2021
Denmark	Recruiting	26.10.2021
France	Recruiting	26.10.2021
Germany	Recruiting	26.10.2021
Poland	Recruiting	26.10.2021

Trial locations

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.

Investigated diseases:

Short-bowel syndrome

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 ID:

2024-515160-32-00

Protocol code:

HM-GLP2-201

NCT ID:

NCT04775706

Trial Phase:

Therapeutic exploratory (Phase II)

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

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