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TerminatedNCT07037420ASTERIAUpdated Aug 7, 2026

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

A Phase 2 interventional study of ALXN2420 and Placebo in Acromegaly, sponsored by Alexion Pharmaceuticals, Inc.. Terminated at 6 sites in 4 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-07.

Sponsored by Alexion Pharmaceuticals, Inc. (part of AstraZeneca) · Phase 2, Interventional, and Treatment

Why this study was terminated
This decision is based on strategic portfolio prioritization
Phase
Phase 2
Study type
Interventional
Enrollment
8
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Acromegaly

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Keywords

  • Acromegaly
  • ALXN2420
  • Somatostatin Analog
  • insulin-like growth factor 1
  • IGF-1
  • SSA therapy
  • GHRA
  • Growth Hormone Receptor Antagonist
03

In context

Acromegaly

202 studies on the registry are indexed under Acromegaly; 19 are open to participants now.

This study's enrollment of 8 is below the median of 43 across 115 interventional studies indexed under Acromegaly.

Browse Acromegaly studies →

Lead sponsor

Alexion Pharmaceuticals, Inc. is the lead sponsor of 255 studies on the registry; 23 are open to participants now.

Of its 101 completed or terminated interventional studies of FDA-regulated products, 75 (74%) have results posted.

First submitted after Alexion Pharmaceuticals, Inc. became part of AstraZeneca.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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* 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

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 hormone replacement therapy for ≥ 3 months prior to Screening
  • Active, 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 ( > 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
  • (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 > 1.5* (except if in free bilirubin linked to a known Gilbert Syndrome) or , ALT, or alkaline phosphatase > 2*ULN
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    ALXN2420

    During the Primary Evaluation Period, participants will receive the first dose of ALXN2420 via SC injection on Day 1, followed by daily administration thereafter for a total of 15 weeks.

    Drug: ALXN2420

  • Placebo comparator
    Placebo

    During the Primary Evaluation Period, participants will receive the first dose of placebo via SC injection on Day 1, followed by daily administration thereafter for a total of 15 weeks.

    Drug: Placebo

  • Experimental
    Open-label Extension Period

    During the Open-label Extension (OLE) Period, participants in the ALXN2420 treatment groups will continue receiving ALXN2420 treatment and participants in the placebo groups will crossover to receive ALXN2420 at Week 15. At the Week 15 Visit, the dose level and the dosing regimen of ALXN2420 will be determined for each participant based on the Week 13 IGF-1 level. The OLE Period assessments will be performed at Weeks 19, 26, 32, 39, 45, and 52.

    Drug: ALXN2420

Interventions

  • DrugALXN2420

    ALXN2420 will be administered via subcutaneous (SC) injection

  • DrugPlacebo

    Placebo will be administered via SC injection.

06

What researchers measure

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

07

Study locations

6 sites
  • Research Site
    Torrance, California 90502, United States
  • Research Site
    Ann Arbor, Michigan 48109, United States
  • Research Site
    Pisa, 56126, Italy
  • Research Site
    Kaunas, LT50009, Lithuania
  • Research Site
    Vilnius, 09112, Lithuania
  • Research Site
    Bucharest, 011863, Romania
08

References and documents

Individual participant data

Plan to share: Yes — Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07037420
Responsible party
Sponsor
First posted
Jun 25, 2025
Start date
Oct 28, 2025
Primary completion
Jun 24, 2026
Completion
Jun 24, 2026
Last update
Aug 7, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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