A Phase 2, Randomized, Double-blinded, Placebo-controlled, Dose Range-finding, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ALXN2420, a Growth Hormone Receptor Antagonist, Administered Subcutaneously in Combination with Somatostatin Analogs in Adult Participants with Acromegaly
Acromegaly is a condition where the body produces too much growth hormone, causing high levels of a protein called IGF-1. This can lead to swelling, joint pain, tiredness, and changes in appearance. Many people take regular medicines such as octreotide or lanreotide, but these treatments do not always bring hormone levels fully under control. This Phase 2 clinical trial is testing a new medicine called ALXN2420. It is given as an injection under the skin alongside a person's existing treatment. The goal is to see if this combination can safely reduce IGF-1 levels into a healthy range and help people feel better day to day. Participants will be placed into groups to receive different doses of the new medicine or a dummy injection (placebo), together with their usual care. Doctors will track hormone levels, symptoms, and quality of life over 15 weeks.
At a glance
What is this study about?
Acromegaly is a rare condition usually caused by a non-cancerous growth on the pituitary gland in the brain. This growth causes the body to produce too much growth hormone, which then prompts the liver to make high levels of a protein known as IGF-1. Over time, high IGF-1 levels can cause bones and soft tissues to grow, leading to enlarged hands, feet, and facial features, as well as joint pain, headaches, and extreme tiredness.
The most common medical treatments for acromegaly are monthly injections called somatostatin analogues, such as lanreotide or octreotide. These medicines help block the release of growth hormone. However, for many people, these standard treatments alone do not lower IGF-1 levels enough to manage symptoms or protect long-term health.
This trial is looking at ALXN2420, an experimental medicine designed to work in a different way. Instead of stopping the brain from releasing growth hormone, it blocks growth hormone from attaching to cells throughout the body. By adding ALXN2420 to standard monthly injections, researchers hope to give patients better hormone control. The study compares different doses of the new drug against a placebo (an inactive dummy jab) to find the safest and most effective dose.
Key takeaways
- Tests a new add-on injection (ALXN2420) to help lower high IGF-1 levels in acromegaly.
- Designed for adults already taking standard monthly injections like lanreotide or octreotide.
- The primary treatment and assessment phase lasts for 15 weeks.
- Uses a placebo group so scientists can fairly test the drug's safety and success.
- Participation is entirely voluntary and you can withdraw at any time.
Who may be eligible?
This study is open to adults aged 18 and older who have been diagnosed with acromegaly.
To be considered, participants must already be receiving regular treatment with standard somatostatin analogue medicines, such as lanreotide or octreotide, but still have hormone levels that could be better controlled.
You may not be eligible if you have certain other serious health problems, abnormal liver or heart tests, or if you are pregnant or breastfeeding. The specialist study team will carry out health checks and blood tests to make sure taking part is completely safe for you.
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.
- I am at least 18 years old.
- I have a confirmed diagnosis of acromegaly.
- I currently receive regular octreotide or lanreotide injections.
- I am willing to attend regular hospital appointments over 15 weeks.
- I am comfortable receiving injections under the skin and having regular blood tests.
What does participation involve?
If you take part, you will continue your usual monthly treatment (octreotide or lanreotide) and will also receive injections of either ALXN2420 or a matching placebo under the skin. You will have regular appointments at the hospital clinic over a 15-week period. During these visits, doctors will take blood samples to measure your IGF-1 levels, check your general health, and ask you to fill out short questionnaires about your symptoms and daily well-being. After the 15-week treatment period, doctors will continue to monitor your health to check for any lasting effects.
Potential risks and benefits
Locations (7)
- —UnverifiedLithuania
- —UnverifiedRomania
- —UnverifiedDenmark
- —UnverifiedItaly
- —UnverifiedHungary
- —UnverifiedPoland
- —UnverifiedNetherlands
Common questions
Will I have to stop taking my usual acromegaly medicine?
No. The study medicine is designed to be taken on top of your existing treatment, such as octreotide or lanreotide.
What is a placebo?
A placebo is a dummy injection that looks identical to the real medicine but contains no active drug. It helps researchers prove whether any improvements are truly caused by the study medicine.
How is the study medicine given?
It is given as an injection just under the skin (subcutaneously), similar to how many other hormone treatments are given.
Will taking part cost me anything?
No. The trial medicine, tests, and doctor visits are provided free of charge, and studies often offer help with travel expenses.
Can I leave the study if I change my mind?
Yes. You can stop taking part at any time and for any reason, and your regular medical team will continue caring for you as normal.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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