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

About

Brief 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.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 2

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

80 Years

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