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

NCT07037420 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: D7890C00001
• Study Type: interventional
• Target: 60
• Locations: 11 countries
• Sites: 45

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.

Conditions

Acromegaly

Keywords

Acromegaly; ALXN2420; Somatostatin Analog; insulin-like growth factor 1; IGF-1; SSA therapy; GHRA; Growth Hormone Receptor Antagonist

Outcome Measures

Primary Outcomes (1)

• Percentage Change From Baseline in Serum IGF-1 Level at Week 15

  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

  Week 15

• Number of Participants Who Achieve of Serum IGF-1 Level ≤1.0 ULN at Week 15

  Week 15

• Change from Basline in Symptoms as assessed by disease specific questionnaire, at Week 15

  Baseline, Week 15

• Change From Baseline in Serum IGF-1 Level at Week 15

  Baseline, Week 15

• Change From Baseline in 36-item Short Form Survey (SF-36) Summary Scores and Subscores at Week 15

  Baseline, Week 15

Study Arms (3)

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.

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.

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.

Drug: ALXN2420

Interventions

Placebo DRUG

Placebo will be administered via SC injection.

Placebo

ALXN2420 DRUG

ALXN2420 will be administered via subcutaneous (SC) injection

ALXN2420; Open-label Extension Period

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Alexion Pharmaceuticals, Inc.: lead

Study Sites (45)

Research Site

Los Angeles, California, 90048, United States

RECRUITING

Research Site

Los Angeles, California, 90095, United States

RECRUITING

Research Site

Torrance, California, 90502, United States

RECRUITING

Research Site

Aurora, Colorado, 80045, United States

WITHDRAWN

Research Site

Boston, Massachusetts, 02114, United States

RECRUITING

Research Site

Ann Arbor, Michigan, 48109, United States

RECRUITING

Research Site

Las Vegas, Nevada, 89148, United States

RECRUITING

Research Site

New York, New York, 10032, United States

RECRUITING

Research Site

Portland, Oregon, 97239, United States

RECRUITING

Research Site

CABA, C1012AAR, Argentina

RECRUITING

Research Site

Ciudad de Buenos Aires, C1180AAD, Argentina

RECRUITING

Research Site

Ciudad de Buenos Aires, C1199, Argentina

RECRUITING

Research Site

Ciudad de Buenos Aires, C1405DCS, Argentina

RECRUITING

Research Site

Curitiba, 80030-110, Brazil

RECRUITING

Research Site

Ribeirão Preto, 14049-901, Brazil

RECRUITING

Research Site

Rio de Janeiro, 20231-092, Brazil

RECRUITING

Research Site

São Paulo, 01420-000, Brazil

RECRUITING

Research Site

Beijing, 100730, China

NOT YET RECRUITING

Research Site

Guangzhou, 510120, China

NOT YET RECRUITING

Research Site

Kunming, 650032, China

NOT YET RECRUITING

Research Site

Shanghai, 201107, China

NOT YET RECRUITING

Research Site

Copenhagen, 2100, Denmark

RECRUITING

Research Site

Odense, 5464, Denmark

RECRUITING

Research Site

Budapest, 1083, Hungary

RECRUITING

Research Site

Budapest, 1134, Hungary

RECRUITING

Research Site

Pécs, 7624, Hungary

RECRUITING

Research Site

Szeged, 6725, Hungary

RECRUITING

Research Site

Cona, 44124, Italy

RECRUITING

Research Site

Genoa, 16132, Italy

RECRUITING

Research Site

Messina, 98125, Italy

RECRUITING

Research Site

Milan, 20132, Italy

NOT YET RECRUITING

Research Site

Naples, 80131, Italy

NOT YET RECRUITING

Research Site

Pisa, 56126, Italy

RECRUITING

Research Site

Roma, 00168, Italy

RECRUITING

Research Site

Kaunas, LT50009, Lithuania

RECRUITING

Research Site

Vilnius, 09112, Lithuania

RECRUITING

Research Site

Leiden, 2333 ZA, Netherlands

NOT YET RECRUITING

Research Site

Rotterdam, 3015 CE, Netherlands

NOT YET RECRUITING

Research Site

Bydgoszcz, 85-605, Poland

WITHDRAWN

Research Site

Gliwice, 44-102, Poland

NOT YET RECRUITING

Research Site

Krakow, 31-501, Poland

NOT YET RECRUITING

Research Site

Warsaw, 03-242, Poland

RECRUITING

Research Site

Wroclaw, 50-367, Poland

RECRUITING

Research Site

Bucharest, 011863, Romania

RECRUITING

Research Site

Cluj-Napoca, 400006, Romania

NOT YET RECRUITING

MeSH Terms

Conditions

Acromegaly

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Central Study Contacts

Alexion Pharmaceuticals, Inc. (Sponsor)

CONTACT

1-855-752-2356; clinicaltrials@alexion.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 25, 2025
• Study Start: October 28, 2025
• Primary Completion (Estimated): January 8, 2027
• Study Completion (Estimated): November 11, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

BR (4); IT (7); DK (2); RO (2); LI (2); HU (4); AR (4); CN (4); US (9); NL (2); PL (5)