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NCT Number: NCT07037420

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

The primary objective of this study is to evaluate the efficacy of 15-week treatment with ALXN2420 versus placebo for decreasing insulin-like growth factor IGF-1 levels, when administered in combination with somatostatin analog (SSA) therapy to adult participants with acromegaly.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, CABA, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Received for ≥ 6 months prior to screening
  • 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

Treatment and study plan

ALXN2420

Drug

ALXN2420 will be administered via subcutaneous (SC) injection

Placebo

Drug

Placebo will be administered via SC injection.

Primary outcomes

  1. Percentage Change From Baseline in Serum IGF-1 Level at Week 15

    Time frame: Baseline, Week 15

Secondary outcomes

  1. Number of Participants Who Achieve Serum IGF-1 Level ≤1.3 Upper Limit of Normal (ULN) at Week 15

    Time frame: Week 15

  2. Number of Participants Who Achieve of Serum IGF-1 Level ≤1.0 ULN at Week 15

    Time frame: Week 15

  3. Change from Basline in Symptoms as assessed by disease specific questionnaire, at Week 15

    Time frame: Baseline, Week 15

  4. Change From Baseline in Serum IGF-1 Level at Week 15

    Time frame: Baseline, Week 15

  5. Change From Baseline in 36-item Short Form Survey (SF-36) Summary Scores and Subscores at Week 15

    Time frame: Baseline, Week 15

  6. Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) at Week 15

    Time frame: Baseline, Week 15

  7. Change From Baseline in Acromegaly Quality of Life (AcroQoL) at Week 15

    Time frame: Baseline, Week 15

  8. Change From Baseline in Global Impression of Severity at Week 15 as Assessed by Patient Global Impression of Severity (PGIS) Scale

    Time frame: Baseline, Week 15

  9. Global Impression of Change at Week 15 as Assessed by Patient Global Impression of Change (PGIC) Scale

    Time frame: Week 15

  10. Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and Adverse Events (AEs) Leading to Study Intervention Discontinuation or Interruption

    Time frame: Baseline (Day 1) through Week 15

  11. Plasma Concentration of ALXN2420

    Time frame: Baseline (Day 1) through Week 15

  12. Number of Participants With Antidrug Antibodies (ADAs)

    Time frame: Baseline (Day 1) through Week 15

Study contacts

Contact information is provided by the study sponsor or research team.

Alexion Pharmaceuticals, Inc. (Sponsor)

CONTACT

[email protected]

1-855-752-2356

Sponsors and collaborators

Lead sponsor

Alexion Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Acronym: ASTERIA

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 25, 2025
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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