ALXN2420 Versus Placebo in Combination With Somatostatin Analogs in Participants With Acromegaly

Launched by ALEXION PHARMACEUTICALS, INC. · Jun 17, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called ALXN2420 to see if it can help lower certain hormone levels in adults with acromegaly, a condition where the body produces too much growth hormone. Participants will continue taking their regular long-acting somatostatin analog (SSA) treatment, which helps control this hormone, and will receive either ALXN2420 or a placebo (a harmless inactive treatment) for 15 weeks. The main goal is to find out if adding ALXN2420 is better at reducing a hormone called IGF-1, which is linked to acromegaly symptoms.

To join the study, adults must have a confirmed diagnosis of acromegaly caused by a specific type of pituitary tumor and have been on a stable monthly SSA treatment for at least six months. They should have shown some response to their current treatment but still have higher than normal IGF-1 levels. People who have had recent pituitary surgery, worsening tumors, certain heart problems, uncontrolled diabetes, or other serious health issues would not be able to participate. If eligible, participants can expect regular medical check-ups and lab tests during the study to monitor their health and hormone levels, while receiving either the new medication or placebo alongside their usual treatment. This study is not yet enrolling participants but aims to find better ways to manage acromegaly in adults who need additional help controlling their hormone levels.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Documented diagnosis of acromegaly, that is, historically documented evidence of a GH-secreting pituitary adenoma based on MRI or pathology report
• * Must be receiving maximum, or maximally tolerated dose per treating physician judgment, of long-acting SSAs (octreotide or lanreotide LAR) and meet both of the following:
• • 1. Received for ≥ 6 months prior to screening
• • 2. Receiving a once-monthly regimen (approximately every 4 weeks). Note: participants on stable regimens of other durations (for example, every 3 or 6 weeks) are not eligible
• • Must be a partial responder to SSAs defined as \> 20% relative IGF 1 reduction during the course of SSA therapy
• • Serum IGF-1 levels \> 1.3 to 5\*ULN inclusive, as assessed at a central laboratory and adjusted for age and sex, based on average of 2 consecutive values obtained during the Screening Period and obtained ≥ 7 days apart
• Exclusion Criteria:
• • Had surgery for pituitary adenoma within the last 6 months before Day 1 or planning to receive surgery for pituitary adenoma during the study
• • Pituitary adenoma that, per Investigator's judgment, is worsening as assessed by pituitary/sellar MRI or computed tomography scan obtained ≤ 6 months prior to screening
• • Pituitary adenoma causing compression of the chiasm
• • Clinical evidence of symptomatic hyperprolactinemia that would necessitate treatment with dopamine agonists
• • Known hypothyroidism or hypocortisolism not adequately treated with a stable dose of thyroid or glucocorticoid hormone replacement therapy for ≥ 3 months prior to Screening
• • Active, clinically significant cardiac disease as judged by the Investigator
• • History of unstable angina, stroke, or acute myocardial infarction ≤ 3 months prior to screening
• • Known uncontrolled type 2 diabetes (HbA1c \> 10%)
• • Active malignant disease ≤ 2 years prior to screening with exception of basal and squamous cell carcinoma of the skin
• • Received any type of fractionated radiotherapy or a second surgical adenectomy for pituitary adenoma within the last 3 years (5 years for conventional radiation) before starting treatment and/or are planning to receive radiotherapy or a second surgical adenectomy during the study
• • Received pegvisomant ≤ 8 weeks prior to screening
• • Received dopamine agonists ≤ 4 weeks prior to screening
• • Received pasireotide LAR ≤ 4 months prior to screening
• • Clinically significant renal or hepatic disease at the time of screening, as judged by the Investigator
• • eGFR (CKD-EPI formula) \< 30 mL/minute/1.73 m\^2 documented based on recent value (\< 3 months prior to randomization)
• • Clinically significant abnormal values for hematology, biochemistry, coagulation, or urinalysis, as judged by the Investigator, including, but not limited to, total bilirubin \> 1.5\*ULN (except if in free bilirubin linked to a known Gilbert Syndrome) or AST, ALT, or alkaline phosphatase \> 2\*ULN