RecruitingPHASE2INTERVENTIONAL

Phase 2 Study to Assess the Safety, PK, and PD of Sonefpeglutide (HM15912) in SBS-IF Subjects

This research study is for adults living with Short Bowel Syndrome (SBS), a condition where the body struggles to absorb enough nutrients from food. We're testing a new medicine called HM15912 to see if it's safe, how it moves through the body, and what effects it has. Some participants will receive the new medicine, while others will receive a placebo (a dummy medicine with no active ingredients). This helps us understand if any changes are due to the medicine itself. The study involves different stages over several months, including screening, treatment, and follow-up, to make sure we gather thorough information about the medicine's potential benefits and side effects.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Hanmi Pharmaceutical Company Limited

Enrolment target

Start

03 Mar 2022

Estimated completion

01 May 2028

Short Bowel Syndrome

What is this study about?

This study is looking at a new medicine, called HM15912, for people who have Short Bowel Syndrome (SBS). SBS happens when a large part of the small intestine is missing or doesn't work properly, often after surgery. This means the body can't absorb enough water, vitamins, and nutrients from food, which can lead to serious health problems. Some people with SBS need ongoing support, like intravenous feeding (feeding directly into a vein), to get the nutrition they need.

The main goal of this study is to find out if HM15912 is safe for people with SBS. We also want to understand how the medicine works in the body and if it has any positive effects on the condition. To do this, some participants will receive the new medicine, and others will receive a placebo – a substance that looks exactly like the medicine but contains no active ingredients. This is standard practice in research to compare the effects of the new medicine against no treatment and ensure we see real changes.

This is a 'Phase 2' study, which means it builds on earlier research and helps us understand more about how the medicine might work, its best dose, and potential side effects in a larger group of people. The information we gather will help decide if this medicine should be studied further in even larger trials, with the long-term aim of finding new ways to help people living with Short Bowel Syndrome.

Key takeaways

This study tests a new medicine (HM15912) for Short Bowel Syndrome.
It aims to check safety and how the medicine works in the body.
You might receive the active medicine or a placebo.
Participation involves regular clinic visits and up to 14 months commitment.
You can stop participating at any time.
Results will help understand if this medicine could be a future treatment.

Who may be eligible?

This study is open to adults who are 18 years old or older and have Short Bowel Syndrome. To be eligible, your SBS should be stable and have been diagnosed at least six months before the study starts. You should not have plans for further intestine surgery during the study period.

There are certain reasons why you might not be able to join. For example, if you have a history of colon cancer or other cancers (unless treated more than five years ago and completely gone). Also, if you've had issues with alcohol or drug abuse in the past year, you won't be able to take part.

Everyone who joins will need to give their informed consent, which means you'll understand what the study involves and agree to take part voluntarily. This also means you're able to follow all the study's instructions.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with Short Bowel Syndrome?
Has your Short Bowel Syndrome been stable for at least 6 months?
Do you have no plans for intestine surgery during the next year?
Do you not have a recent history of certain cancers or substance abuse?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll go through several stages. First, there's a screening period to check if the study is right for you. If you qualify, there will be a short 'run-in' period before the main treatment begins. For six months, you'll receive either the new medicine (HM15912) or a placebo (a dummy medicine) through an injection under the skin. Neither you nor your study doctor will know which you are receiving – this is called 'double-blind' and helps make the results fair.

After these six months, if you're still doing well and the study allows, you might be offered the chance to continue with an 'extension' treatment period for another seven months. Throughout the study, you'll have regular visits to the clinic for assessments. These will include check-ups, blood tests, and other procedures to monitor your health, how the medicine is working, and any side effects. Finally, there will be a one-month safety follow-up period after your last dose to ensure your health remains stable. The total time you could be involved in the study could be up to 14 months if you participate in the extension period.

Potential risks and benefits

Participating in a clinical trial offers potential benefits, such as contributing to medical knowledge that could help future patients with Short Bowel Syndrome, and receiving close medical monitoring from experts. You might also have access to a new medicine before it's widely available. However, there are potential risks, including side effects from the study medicine (which might be unknown), the possibility of receiving a placebo, and the need for regular clinic visits, which can take time and effort. You will be told about all known risks before you agree to join. It is very important to remember that joining a study is always voluntary, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (14)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Brigham & Women's Hospital
Verified postcode
Boston, United States· Recruiting
The Cleveland Clinic Foundation
Verified postcode
Cleveland, United States· Recruiting
UZ Leuven
Verified postcode
Leuven, Belgium· Recruiting
Rigshospitalet Department of Digestive Diseases, Transplantation and General Surgery Section for Intestinal Failure
Verified postcode
Copenhagen, Denmark· Recruiting
Hopital Beaujon
Verified postcode
Clichy, France· Recruiting
Centre Hospitalier Universitaire de Bordeaux
Verified postcode
Bordeaux, France· Recruiting
Les Hospices Civils de Lyon
Verified postcode
Lyon, France· Recruiting
Centre Hospitalier Universitaire de Nice
Verified postcode
Nice, France· Recruiting
Asklepios Klinik St. Georg
Verified postcode
Hamburg, Germany· Recruiting
Universitätsklinikum Tübingen
Verified postcode
Tübingen, Germany· Recruiting
Wojewodzki Specjalistyczny Szpital im. Mikołaja Pirogowa w Łodzi
Verified postcode
Lodz, Poland· Recruiting
Samsung Medical Center
Verified postcode
Seoul, South Korea· Recruiting

Common questions

What is Short Bowel Syndrome?

It's a condition where your body can't absorb enough nutrients because parts of your small intestine are missing or don't work properly.

What is HM15912?

It's the new medicine being tested in this study to see if it's safe and helps people with Short Bowel Syndrome.

What does 'placebo' mean?

A placebo is a dummy medicine that looks like the real thing but has no active ingredients. It helps researchers compare effects.

How will I know if I'm getting the active medicine or a placebo?

Neither you nor your study doctor will know during the study. This is normal practice to keep the results fair.

How long will I be in the study?

The study could last up to 14 months, including treatment periods and follow-up visits.

How to find out more

Wooyoung Amy Hong

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

Always speak to your GP or specialist before deciding to take part in a study.