Actively Recruiting
A Phase 2 Study of ALXN2420 Versus Placebo With Somatostatin Analogs in Adults With Acromegaly
Led by Alexion Pharmaceuticals, Inc. · Updated on 2026-04-07
60
Participants Needed
45
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of a 15-week treatment with ALXN2420 compared to a placebo in adults with acromegaly, a condition caused by excess growth hormone. The study aims to see if ALXN2420, given alongside somatostatin analog therapy, can reduce levels of insulin-like growth factor 1 (IGF-1), which is linked to acromegaly symptoms. This is a Phase 2 randomized, double-blind trial sponsored by Alexion Pharmaceuticals, Inc. Participants will receive either ALXN2420 or a placebo through daily subcutaneous injections for 15 weeks during the Primary Evaluation Period. After this, an Open-label Extension period allows those initially on placebo to switch to ALXN2420, with dosing adjusted based on IGF-1 levels at Week 13. Follow-up assessments occur at Weeks 19, 26, 32, 39, 45, and 52 to monitor treatment effects. During the study, participants will undergo regular evaluations of their IGF-1 blood levels and complete symptom and quality of life questionnaires. Researchers will track changes from baseline in IGF-1, symptom severity, health surveys, and adverse events throughout the trial. Safety and the body’s response to ALXN2420 will also be monitored over the course of the study, which lasts up to 52 weeks including the extension.
CONDITIONS
Brief Title
ALXN2420 Versus Placebo in Combination With Somatostatin Analogs in Participants With Acromegaly
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years
- Documented diagnosis of acromegaly with evidence of a growth hormone-secreting pituitary adenoma by MRI or pathology
- Receiving maximum or maximally tolerated dose of long-acting somatostatin analogs (octreotide or lanreotide LAR) once monthly for at least 6 months prior to screening
- Partial responder to somatostatin analog therapy with more than 20% reduction in IGF-1 levels
- Serum IGF-1 levels between more than 1.3 and up to 5 times the upper limit of normal, confirmed by two measurements at least 7 days apart
You will not qualify if you...
- Pituitary adenoma surgery within 6 months before Day 1 or planned surgery during the study
- Worsening pituitary adenoma as judged by recent MRI or CT scan within 6 months before screening
- Pituitary adenoma causing optic chiasm compression
- Symptomatic hyperprolactinemia requiring dopamine agonist treatment
- Untreated or unstable hypothyroidism or hypocortisolism within 3 months prior to screening
- Active significant cardiac disease or recent unstable angina, stroke, or heart attack within 3 months prior to screening
- Uncontrolled type 2 diabetes with HbA1c greater than 10%
- Active malignant disease within 2 years prior to screening except for certain skin cancers
- Recent radiotherapy or second pituitary surgery within 3 to 5 years prior to treatment or planned during the study
- Use of pegvisomant within 8 weeks, dopamine agonists within 4 weeks, or pasireotide LAR within 4 months prior to screening
- Clinically significant kidney or liver disease or abnormal lab values, including low eGFR or high bilirubin and liver enzymes, as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 15 weeks
Participants receive ALXN2420 or placebo via daily subcutaneous injections in combination with somatostatin analogs for acromegaly.
Daily dosing with visits at Baseline and Week 15
Duration - Up to 37 weeks
Participants who continue in the open-label extension receive ALXN2420 with dosing determined by IGF-1 levels at Week 13.
Visits at Weeks 19, 26, 32, 39, 45, and 52
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
Research Team
A
Alexion Pharmaceuticals, Inc. (Sponsor)
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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