Study of ALXN2420 with somatostatin analogs for adults with acromegaly to evaluate effectiveness in lowering IGF-1 levels

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What is this study about?

This study focuses on people with Acromegaly, a condition caused by a tumor in the pituitary gland that produces excess growth hormone. The research evaluates a new medication called ALXN2420 used together with existing treatments called somatostatin analogs (octreotide acetate or lanreotide acetate). These medications help control the excessive hormone production that causes the symptoms of acromegaly.

The purpose of this study is to determine if ALXN2420 can help lower levels of a hormone called IGF-1 in people with acromegaly when combined with standard treatments. The study compares ALXN2420 to placebo, with both being given alongside regular acromegaly medications. The treatment period lasts for 15 weeks, during which participants receive either ALXN2420 or placebo through injections under the skin.

Throughout the study, participants continue their regular acromegaly medications, which are given as injections either into the muscle or under the skin once every four weeks. The study monitors how well the combination of treatments works by measuring hormone levels and tracking any changes in symptoms. Participants also complete questionnaires about their quality of life and overall health during the study period.

1 Initial assessment

You will begin the study after meeting specific requirements, including having acromegaly confirmed by MRI or pathology report

Your current treatment must include long-acting somatostatin analogs (SSAs) for at least 6 months before starting the study

Your IGF-1 levels will be checked twice during screening, with measurements taken at least 7 days apart

2 Treatment assignment

You will be randomly assigned to receive either ALXN2420 or a matching placebo

The medication will be given by subcutaneous injection (under the skin)

You will continue your regular SSA treatment throughout the study

3 Treatment period

The treatment period lasts for 15 weeks

Your IGF-1 levels will be monitored throughout the study

You will complete several questionnaires about your symptoms and quality of life

Regular blood tests will check the concentration of the study medication in your system

Your health status will be monitored for any side effects or reactions to the treatment

4 Final assessment

At week 15, final measurements of your IGF-1 levels will be taken

You will complete final questionnaires about your symptoms and quality of life

The medical team will perform a final evaluation of your health status

Blood samples will be checked for the presence of antidrug antibodies

Who Can Join the Study?

  • Age between 18 and 80 years old at the time of screening
  • Must have a confirmed diagnosis of acromegaly with documented evidence of a growth hormone (GH) producing pituitary tumor shown by MRI scan or tissue examination
  • Must be currently taking long-acting SSA medication (a type of hormone therapy) with the following conditions:
    • Taking the maximum or highest tolerable dose as determined by your doctor
    • Been on the medication for at least 6 months
    • Receiving treatment once every month (approximately every 4 weeks)
  • Must show partial response to SSA therapy, meaning your IGF-1 levels (a hormone that indicates disease activity) have decreased by more than 20% while on treatment
  • Must have IGF-1 levels that are:
    • At least 1.3 times higher than the normal upper limit
    • Not more than 5 times the normal upper limit
    • Confirmed by two separate blood tests taken at least 7 days apart

Who Cannot Join the Study?

  • History of pituitary surgery (brain surgery to remove tumors from the pituitary gland) within 6 months before starting the study
  • Radiation therapy to the pituitary gland within the last 10 years
  • Previous treatment with growth hormone receptor blockers in the past 6 months
  • Severe or uncontrolled high blood pressure (blood pressure readings above 160/100 mmHg)
  • History of heart attack or stroke in the past 6 months
  • Severe liver problems (liver function tests more than 3 times above normal limits)
  • Severe kidney problems (requiring dialysis or with severely reduced kidney function)
  • Active or chronic infections
  • Current cancer diagnosis or cancer treatment within the past 5 years
  • Pregnant or breastfeeding women
  • Participation in another clinical trial within 30 days before this study
  • Known allergies to similar medications or their components
  • Unstable mental health conditions
  • Alcohol or drug abuse within the past year
  • Any condition that, in the opinion of the study doctor, would make participation unsafe

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Central Hospital Of Northern Pest Military Hospital Budapest Hungary
Mazowiecki Szpital Brodnowski Sp. z o.o. Warsaw Poland
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos Kaunas Lithuania
National Institute Of Endocrinology C.I. Parhon Bucharest Romania
Odense University Hospital Odense Denmark
Ospedale San Raffaele S.r.l. Milan Italy
Semmelweis University Budapest Hungary
IRCCS Ospedale Policlinico San Martino Genoa Italy
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Cracow Poland
Rigshospitalet Copenhagen Denmark
University Of Pecs Pecs Hungary
A.O.U. Policlinico G. Martino Di Messina Messina Italy
Universita’ Degli Studi Di Ferrara Ferrara Italy
University Of Szeged Szeged Hungary
Azienda Ospedaliero Universitaria Pisana Pisa Italy
Lnsmo Uyyttuzvozav Muhbpab Caqxpxm (qlwsq Leiden The Netherlands
Vaqfisd Umgocopxbsfmi Ir Vilnius Lithuania
Efllrwe Uhxrlfoxbozm Mbuvfot Cwoifur Rxqpylttv (kbmrksi Mdr Rotterdam The Netherlands
Nhdsgwuo Itdnpkmp Owkwujxlg Irq Marws Syhieozygixugpbxveqmsmqgorwd Itipgmsc Bfpbjkop Cracow Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Denmark Denmark
Not yet recruiting
01.09.2025
Hungary Hungary
Not yet recruiting
01.09.2025
Italy Italy
Not yet recruiting
01.09.2025
Lithuania Lithuania
Not yet recruiting
01.09.2025
Poland Poland
Not yet recruiting
01.09.2025
Romania Romania
Not yet recruiting
01.09.2025
The Netherlands The Netherlands
Not yet recruiting
01.09.2025

Trial locations

ALXN2420 is an experimental medication that works as a growth hormone receptor antagonist. It is designed to block the effects of growth hormone in the body. This medication is given as an injection under the skin (subcutaneously) to treat acromegaly, a condition where the body produces too much growth hormone.

Somatostatin Analogs (SSAs) are medications that help control hormone production in the body. They work by reducing the release of growth hormone and are commonly used to treat acromegaly. These medications are used in combination with ALXN2420 in this trial to better manage the condition.

Acromegaly – A hormonal disorder that develops when the pituitary gland produces too much growth hormone during adulthood. The condition results in gradual enlargement of body tissues, including hands, feet, facial features, and internal organs. People with acromegaly may notice increased ring size, shoe size, and changes in facial appearance, such as protruding brow and lower jaw, enlarged nose, and widened spaces between teeth. The condition typically develops slowly over many years, and changes can be so gradual that they’re often not noticed by people who see the affected person daily. Acromegaly can also cause other symptoms like joint pain, increased sweating, and fatigue. The disorder affects both men and women equally.

Trial ID:
2025-521243-20-00
Protocol code:
ALXN2420-Acro-201
Trial Phase:
Therapeutic exploratory (Phase II)

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