RecruitingPHASE3INTERVENTIONAL

A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs

This study is investigating a new medication called Debio 4126 for people living with acromegaly. Acromegaly is a condition where the body produces too much growth hormone. Participants in this study will have already been treated for acromegaly with medicines like octreotide or lanreotide. The main goal is to find out if Debio 4126 can effectively keep a certain hormone level (called IGF-1) stable, comparing it to a placebo (a dummy drug). This research aims to understand if Debio 4126 could be a helpful new option for managing acromegaly, potentially improving quality of life for those affected by the condition.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Debiopharm International SA

Enrolment target

119

Start

26 Nov 2025

Estimated completion

01 Mar 2029

Acromegaly

What is this study about?

This study is about a new medicine called Debio 4126, designed for people who have acromegaly. Acromegaly is a long-term condition where the body makes too much growth hormone. This can cause various health problems, like changes in how your face looks, bigger hands and feet, and can affect your heart, bones, and other organs. Many people with acromegaly are already treated with medicines called somatostatin analogues, such as octreotide or lanreotide. This trial aims to see if Debio 4126 can help these people keep their hormone levels stable.

The main purpose of the study is to compare Debio 4126 with a placebo. A placebo looks like the real medicine but doesn't contain any active drug. This helps the researchers understand if any changes seen are truly due to Debio 4126 or if they might happen anyway. Participants won't know if they are getting Debio 4126 or the placebo at first. The study will mainly look at whether Debio 4126 can keep a specific hormone, called IGF-1 (Insulin-like Growth Factor-1), at healthy levels.

Developing new and effective treatments for acromegaly is important. This study could help us learn if Debio 4126 is a safe and effective option that could improve the health and well-being of people living with acromegaly in the future.

Key takeaways

This study is testing a new drug, Debio 4126, for acromegaly.
It aims to see if Debio 4126 can keep hormone levels stable.
Participants will have been treated for acromegaly with other medicines.
It compares Debio 4126 to a placebo (dummy drug).
Participation involves regular clinic visits and health checks.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old and have been diagnosed with acromegaly. You should already be receiving treatment with specific medications (octreotide or lanreotide) for at least six months, and your dose of this medication must have been stable for the last three months. Also, your body needs to be managing your basic functions well, like your blood, liver, and kidneys, and your IGF-1 hormone levels should be within a normal range when you are first checked.

There are also some reasons why you might not be able to join. For example, if you have certain existing eye problems due to acromegaly, or if you have gallstones causing symptoms, or have had recent specific stomach problems. Also, if you've had certain treatments recently, like radiotherapy to your pituitary gland, or surgery on your pituitary gland within the last six months, you wouldn't be able to participate. Having uncontrolled thyroid issues or diabetes would also prevent you from joining, as would recent heart problems or strokes.

The research team will carefully review all your medical information to decide if this study is suitable for you. Their main goal is to ensure your safety and that the study results are clear and accurate.

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?
Do you have acromegaly and are currently on octreotide or lanreotide?
Has your current acromegaly medication dose been stable for the last 3 months?
Are your IGF-1 hormone levels currently within the normal range?
Have you not had pituitary surgery in the last 6 months?
Do you have any significant, uncontrolled health conditions like severe heart problems or diabetes?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to the clinic over a number of months. During these visits, you would have medical check-ups, blood tests to measure your hormone levels and general health, and other assessments to monitor your condition. You will also be given either the study drug (Debio 4126) or a placebo to take. You won't know which one you are receiving at first. The study is planned to last for quite some time, potentially involving an initial blinded period where you don't know what you're taking, followed by an open-label period where everyone receives Debio 4126. The full duration of your participation would be explained in detail by the study team.

Potential risks and benefits

Participating in this study might offer a potential benefit of receiving a new experimental treatment for acromegaly that could help manage your hormone levels, or receiving the active drug at a later stage. However, as with any medication, there are potential risks and side effects that could occur from taking Debio 4126. These will be fully explained by the study team. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (71)

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

Cedars Sinai Medical Center
Verified postcode
Los Angeles, United States· Recruiting
Northwestern University
Verified postcode
Chicago, United States· Recruiting
Harvard Medical School
Verified postcode
Boston, United States· Recruiting
Washington University-School of Medicine
Verified postcode
St Louis, United States· Recruiting
Palm Research Center Inc
Verified postcode
Las Vegas, United States· Recruiting
The Cleveland Clinic
Verified postcode
Cleveland, United States· Recruiting
The Ohio State University
Verified postcode
Columbus, United States· Recruiting
Oregon Health & Science University
Verified postcode
Portland, United States· Recruiting
Thomas Jefferson University
Verified postcode
Philadelphia, United States· Recruiting
Medical University Graz
Verified postcode
Graz, Austria· Recruiting
Medizinische Universitaet Wien - Division of Endocrinology and Metabolism
Verified postcode
Vienna, Austria· Recruiting
UZ Gent
Verified postcode
Ghent, Belgium· Recruiting

Common questions

What is Debio 4126?

Debio 4126 is an investigational medicine being tested to see if it can help manage acromegaly.

What is a placebo?

A placebo is a 'dummy' medicine that looks like the study drug but contains no active ingredients. It's used to compare the effects of the real drug.

Will I know if I'm getting the drug or the placebo?

For the first part of the study, neither you nor your doctor will know if you're receiving Debio 4126 or the placebo. This is called a 'double-blind' study.

How long will the study last?

The study involves different periods, and your participation may last for several months, with regular clinic visits.

Can I stop participating if I want to?

Yes, you can leave the study at any time, for any reason, and your decision will not affect your future medical care.

How to find out more

Debiopharm International S.A

clinicaltrials@debiopharm.com +41 21 321 01 11 Official trial record

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