Actively Recruiting

Phase 2
Age: 18Years - 80Years
All Genders
NCT07037420

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

Led by Alexion Pharmaceuticals, Inc. · Updated on 2026-04-07

60

Participants Needed

45

Research Sites

106 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 80 years
  • Documented diagnosis of acromegaly with a GH-secreting pituitary adenoma confirmed by MRI or pathology
  • Receiving maximally tolerated long-acting somatostatin analogs (octreotide or lanreotide LAR) once monthly for at least 6 months prior to screening
  • Partial responder to SSA therapy with more than 20% reduction in IGF-1 during treatment
  • Serum IGF-1 levels between 1.3 and 5 times the upper limit of normal, confirmed by two tests at least 7 days apart during screening
Not Eligible

You will not qualify if you...

  • Pituitary surgery within 6 months before study start or planned during the study
  • Worsening pituitary adenoma as judged by recent MRI or CT scan
  • Pituitary adenoma causing optic chiasm compression
  • Symptomatic hyperprolactinemia requiring dopamine agonist treatment
  • Untreated or unstable hypothyroidism or hypocortisolism
  • Active significant cardiac disease or recent unstable angina, stroke, or heart attack within 3 months
  • Uncontrolled type 2 diabetes with HbA1c over 10%
  • Active cancer within 2 years except certain skin cancers
  • Recent fractionated radiotherapy or second pituitary surgery within last 3-5 years or planned during study
  • Use of pegvisomant within 8 weeks or dopamine agonists within 4 weeks prior to screening
  • Use of pasireotide LAR within 4 months prior to screening
  • Significant kidney or liver disease or abnormal lab values as judged by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 45 locations

1

Research Site

Los Angeles, California, United States, 90048

Actively Recruiting

2

Research Site

Los Angeles, California, United States, 90095

Actively Recruiting

3

Research Site

Torrance, California, United States, 90502

Actively Recruiting

4

Research Site

Aurora, Colorado, United States, 80045

Withdrawn

5

Research Site

Boston, Massachusetts, United States, 02114

Actively Recruiting

6

Research Site

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

7

Research Site

Las Vegas, Nevada, United States, 89148

Actively Recruiting

8

Research Site

New York, New York, United States, 10032

Actively Recruiting

9

Research Site

Portland, Oregon, United States, 97239

Actively Recruiting

10

Research Site

CABA, Argentina, C1012AAR

Actively Recruiting

11

Research Site

Ciudad de Buenos Aires, Argentina, C1180AAD

Actively Recruiting

12

Research Site

Ciudad de Buenos Aires, Argentina, C1199

Actively Recruiting

13

Research Site

Ciudad de Buenos Aires, Argentina, C1405DCS

Actively Recruiting

14

Research Site

Curitiba, Brazil, 80030-110

Actively Recruiting

15

Research Site

Ribeirão Preto, Brazil, 14049-901

Actively Recruiting

16

Research Site

Rio de Janeiro, Brazil, 20231-092

Actively Recruiting

17

Research Site

São Paulo, Brazil, 01420-000

Actively Recruiting

18

Research Site

Beijing, China, 100730

Not Yet Recruiting

19

Research Site

Guangzhou, China, 510120

Not Yet Recruiting

20

Research Site

Kunming, China, 650032

Not Yet Recruiting

21

Research Site

Shanghai, China, 201107

Not Yet Recruiting

22

Research Site

Copenhagen, Denmark, 2100

Actively Recruiting

23

Research Site

Odense, Denmark, 5464

Actively Recruiting

24

Research Site

Budapest, Hungary, 1083

Actively Recruiting

25

Research Site

Budapest, Hungary, 1134

Actively Recruiting

26

Research Site

Pécs, Hungary, 7624

Actively Recruiting

27

Research Site

Szeged, Hungary, 6725

Actively Recruiting

28

Research Site

Cona, Italy, 44124

Actively Recruiting

29

Research Site

Genoa, Italy, 16132

Actively Recruiting

30

Research Site

Messina, Italy, 98125

Actively Recruiting

31

Research Site

Milan, Italy, 20132

Not Yet Recruiting

32

Research Site

Naples, Italy, 80131

Not Yet Recruiting

33

Research Site

Pisa, Italy, 56126

Actively Recruiting

34

Research Site

Roma, Italy, 00168

Actively Recruiting

35

Research Site

Kaunas, Lithuania, LT50009

Actively Recruiting

36

Research Site

Vilnius, Lithuania, 09112

Actively Recruiting

37

Research Site

Leiden, Netherlands, 2333 ZA

Not Yet Recruiting

38

Research Site

Rotterdam, Netherlands, 3015 CE

Actively Recruiting

39

Research Site

Bydgoszcz, Poland, 85-605

Withdrawn

40

Research Site

Gliwice, Poland, 44-102

Not Yet Recruiting

41

Research Site

Krakow, Poland, 31-501

Not Yet Recruiting

42

Research Site

Warsaw, Poland, 03-242

Actively Recruiting

43

Research Site

Wroclaw, Poland, 50-367

Actively Recruiting

44

Research Site

Bucharest, Romania, 011863

Actively Recruiting

45

Research Site

Cluj-Napoca, Romania, 400006

Not Yet Recruiting

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Research Team

A

Alexion Pharmaceuticals, Inc. (Sponsor)

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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