AcromegalyPhase 2ASTERIANCT07037420
ALXN2420 Versus Placebo in Combination With Somatostatin Analogs in Participants With Acromegaly
A Phase 2 study testing ALXN2420 in people with Acromegaly, run by Alexion Pharmaceuticals, Inc. at 6 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acromegaly
- What is being tested?
- ALXN2420
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 28 Oct 2025to 24 Jun 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
United States2 sites
Research Site
Ann Arbor, Michigan, 48109
Research Site
Torrance, California, 90502
About this study
Official 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
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.
- Conditions
- Acromegaly
- Being tested
- ALXN2420, Placebo
- Keywords
- Acromegaly, ALXN2420, Somatostatin Analog, insulin-like growth factor 1, IGF-1, SSA therapy, GHRA, Growth Hormone Receptor Antagonist
- Medical subject headings
- Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALXN2420Drug
ALXN2420 will be administered via subcutaneous (SC) injection
PlaceboDrug
Placebo will be administered via SC injection.
| Study group | Role | What they receive |
|---|---|---|
| ALXN2420 | Experimental | 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. Receives: Drug: ALXN2420 |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
| Open-label Extension Period | Experimental | 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. Receives: Drug: ALXN2420 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change From Baseline in Serum IGF-1 Level at Week 15
Measured: Baseline, Week 15
Secondary outcomes (12)
Number of Participants Who Achieve Serum IGF-1 Level ≤1.3 Upper Limit of Normal (ULN) at Week 15
Measured: Week 15
Number of Participants Who Achieve of Serum IGF-1 Level ≤1.0 ULN at Week 15
Measured: Week 15
Change from Basline in Symptoms as assessed by disease specific questionnaire, at Week 15
Measured: Baseline, Week 15
Change From Baseline in Serum IGF-1 Level at Week 15
Measured: Baseline, Week 15
Change From Baseline in 36-item Short Form Survey (SF-36) Summary Scores and Subscores at Week 15
Measured: Baseline, Week 15
Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) at Week 15
Measured: Baseline, Week 15
Change From Baseline in Acromegaly Quality of Life (AcroQoL) at Week 15
Measured: Baseline, Week 15
Change From Baseline in Global Impression of Severity at Week 15 as Assessed by Patient Global Impression of Severity (PGIS) Scale
Measured: Baseline, Week 15
Global Impression of Change at Week 15 as Assessed by Patient Global Impression of Change (PGIC) Scale
Measured: Week 15
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
Measured: Baseline (Day 1) through Week 15
Plasma Concentration of ALXN2420
Measured: Baseline (Day 1) through Week 15
Number of Participants With Antidrug Antibodies (ADAs)
Measured: Baseline (Day 1) through Week 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start28 Oct 2025
- Primary completion24 Jun 2026
- Study completion24 Jun 2026
Why it stopped: This decision is based on strategic portfolio prioritization
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- More trials run by Alexion Pharmaceuticals, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07037420
- Sponsor's protocol ID
- D7890C00001
- Acronym
- ASTERIA
- Status last verified
- Aug 2026
- First submitted
- 27 May 2025
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.