Back to Trials
NCT07037420PHASE2Recruiting

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

Alexion Pharmaceuticals, Inc.

Start Date

10/28/2025

Completion Date

11/11/2027

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.

Eligibility Criteria

Age Range: 18 years to 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: 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\*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

Interventions

DRUG

ALXN2420

DRUG

Placebo

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Acromegaly

Locations

Research Site

Los Angeles, California 90048

United States

Research Site

Los Angeles, California 90095

United States

Research Site

Torrance, California 90502

United States

Research Site

Aurora, Colorado 80045

United States

Research Site

Boston, Massachusetts 02114

United States

Research Site

Ann Arbor, Michigan 48109

United States

Research Site

Las Vegas, Nevada 89148

United States

Research Site

New York, New York 10032

United States

Research Site

Portland, Oregon 97239

United States

Research Site

CABA, C1012AAR

Argentina

Research Site

Ciudad de Buenos Aires, C1180AAD

Argentina

Research Site

Ciudad de Buenos Aires, C1199

Argentina

Research Site

Ciudad de Buenos Aires, C1405DCS

Argentina

Research Site

Curitiba, 80030-110

Brazil

Research Site

Ribeirão Preto, 14049-901

Brazil

Research Site

Rio de Janeiro, 20231-092

Brazil

Research Site

São Paulo, 01420-000

Brazil

Research Site

Beijing, 100730

China

Research Site

Guangzhou, 510120

China

Research Site

Kunming, 650032

China

Research Site

Shanghai, 201107

China

Research Site

Copenhagen, 2100

Denmark

Research Site

Odense, 5464

Denmark

Research Site

Budapest, 1083

Hungary

Research Site

Budapest, 1134

Hungary

Research Site

Pécs, 7624

Hungary

Research Site

Szeged, 6725

Hungary

Research Site

Cona, 44124

Italy

Research Site

Genoa, 16132

Italy

Research Site

Messina, 98125

Italy

Research Site

Milan, 20132

Italy

Research Site

Naples, 80131

Italy

Research Site

Pisa, 56126

Italy

Research Site

Roma, 00168

Italy

Research Site

Kaunas, LT50009

Lithuania

Research Site

Vilnius, 09112

Lithuania

Research Site

Leiden, 2333 ZA

Netherlands

Research Site

Rotterdam, 3015 CE

Netherlands

Research Site

Bydgoszcz, 85-605

Poland

Research Site

Gliwice, 44-102

Poland

Research Site

Krakow, 31-501

Poland

Research Site

Warsaw, 03-242

Poland

Research Site

Wroclaw, 50-367

Poland

Research Site

Bucharest, 011863

Romania

Research Site

Cluj-Napoca, 400006

Romania