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ALXN2420 plus monthly somatostatin analogs versus placebo for acromegaly

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

PHASE2 · Alexion Pharmaceuticals, Inc. · NCT07037420

This trial tests whether adding ALXN2420 to monthly long-acting somatostatin analog injections lowers IGF‑1 in adults with acromegaly who remain partially responsive to SSA therapy.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment60 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorAlexion Pharmaceuticals, Inc. (industry)
Drugs / interventionsradiation
Locations45 sites (Los Angeles, California and 44 other locations)
Trial IDNCT07037420 on ClinicalTrials.gov

What this trial studies

This Phase 2, placebo-controlled interventional trial adds 15 weeks of ALXN2420 or matching placebo on top of participants' ongoing monthly long-acting somatostatin analog (octreotide or lanreotide) therapy. Eligible adults have a documented GH-secreting pituitary adenoma, have been on a stable, once-monthly SSA regimen for at least 6 months, and are partial responders with average central-lab IGF‑1 between 1.3 and 5 times the age- and sex-adjusted upper limit of normal. The primary focus is change in IGF‑1 measured centrally using the average of two screening values and subsequent on-treatment measurements. Recent pituitary surgery within 6 months is excluded to avoid confounding recovery-related hormone changes.

Who should consider this trial

Good fit: Adults with a documented GH-secreting pituitary adenoma who have been on a once-monthly long-acting SSA for ≥6 months, are partial responders (>20% IGF‑1 reduction on SSA), and have central-lab average IGF‑1 of 1.3–5×ULN are ideal candidates.

Not a fit: Patients with well-controlled IGF‑1, those on non-monthly SSA schedules, or those who had pituitary surgery within the past 6 months are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, adding ALXN2420 could lower IGF‑1 further and improve biochemical disease control and related symptoms for patients not fully controlled on somatostatin analogs alone.

How similar studies have performed: Other combination strategies—such as adding pegvisomant to SSAs—have lowered IGF‑1 in patients with incomplete response, but ALXN2420 is a novel agent with limited prior published clinical data in acromegaly.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Los Angeles, California and 44 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Acromegaly, ALXN2420, Somatostatin Analog, insulin-like growth factor 1, IGF-1, SSA therapy, GHRA, Growth Hormone Receptor Antagonist

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.