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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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-521243-20-00
Acronym
ALXN2420-Acro-201
Enrollment
32
Registered
2025-09-29
Start date
2025-10-23
Completion date
Unknown
Last updated
2026-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acromegaly

Brief summary

Percentage change from baseline in serum IGF-1 level at Week 15

Detailed description

1_Number of Participants Who Achieve Serum IGF-1 Level ≤1.3 Upper Limit of Normal (ULN) at Week 15, 2_Number of Participants Who Achieve Serum IGF-1 Level ≤1.0 ULN at Week 15, 3_Change From Baseline in Symptoms, as Assessed by disease specific questionnaire, at Week 15, 4_Change From Baseline in Serum IGF-1 Level at Week 15, 5_Change From Baseline in 36-item Short Form Survey (SF-36) Summary Scores and Subscores at Week 15, 6_Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) at Week 15, 7_Change from baseline in Acromegaly Quality of Life (AcroQoL) at Week 15, 8_Change From Baseline in Global Impression of Severity at Week 15 as Assessed by Patient Global Impression of Severity (PGIS) Scale, 9_Global Impression of Change at Week 15 as Assessed by Patient Global Impression of Change (PGIC) Scale, 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 through Week 15, 11_Plasma Concentration of ALXN2420 over time through Week 15, 12_Number of Participants With Antidrug Antibodies (ADAs) through Week 15

Interventions

DRUGOCTREOTIDE ACETATE
DRUGmatching placebo for ALXN2420

Sponsors

Alexion Pharmaceuticals Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Percentage change from baseline in serum IGF-1 level at Week 15

Secondary

MeasureTime frame
1_Number of Participants Who Achieve Serum IGF-1 Level ≤1.3 Upper Limit of Normal (ULN) at Week 15, 2_Number of Participants Who Achieve Serum IGF-1 Level ≤1.0 ULN at Week 15, 3_Change From Baseline in Symptoms, as Assessed by disease specific questionnaire, at Week 15, 4_Change From Baseline in Serum IGF-1 Level at Week 15, 5_Change From Baseline in 36-item Short Form Survey (SF-36) Summary Scores and Subscores at Week 15, 6_Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) at Week 15, 7_Change from baseline in Acromegaly Quality of Life (AcroQoL) at Week 15, 8_Change From Baseline in Global Impression of Severity at Week 15 as Assessed by Patient Global Impression of Severity (PGIS) Scale, 9_Global Impression of Change at Week 15 as Assessed by Patient Global Impression of Change (PGIC) Scale, 10_Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and Adverse Events (AEs) Leading to Study Intervention

Countries

Denmark, Hungary, Italy, Lithuania, Netherlands, Poland, Romania

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026