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

Study Identifier:
D7890C00001
ClinicalTrials.gov Identifier:
NCT07037420
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
1-855-752-2356 or [email protected]
Recruiting

Study Details

Medical Condition
  • Acromegaly
Study Drug
  • Drug: ALXN2420
  • Drug: Placebo
Date
Oct 2025 - Jan 2027
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 80 Years
Requirements Information
Inclusion and 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:
  • 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
Sex
Female & Male
Age
18 - 80 Years

Study Details

Medical Condition
  • Acromegaly
Study Drug
  • Drug: ALXN2420
  • Drug: Placebo
Date
Oct 2025 - Jan 2027
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 80 Years years
Requirements Information
Inclusion and 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:
  • 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

Protocol 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.

Trial Locations

Location
Status
Location
Research Site
Los Angeles, California, United States, 90048
Status
Not yet recruiting
Location
Research Site
Los Angeles, California, United States, 90095
Status
Not yet recruiting
Location
Research Site
Torrance, California, United States, 90502
Status
Recruiting
Location
Research Site
Aurora, Colorado, United States, 80045
Status
Withdrawn
Location
Research Site
Boston, Massachusetts, United States, 02114
Status
Not yet recruiting
Location
Research Site
Ann Arbor, Michigan, United States, 48109
Status
Recruiting
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