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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Alexion Pharmaceuticals, Inc.
Study ID
NCT07037420
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Acromegaly

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • ALXN2420 — DRUG
    ALXN2420 will be administered via subcutaneous (SC) injection
  • Placebo — DRUG
    Placebo will be administered via SC injection.

Study Details

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.

Key Dates

Start date
Oct 28, 2025
Status verified
Apr 2026
Primary completion
Jan 8, 2027
Completion
Nov 11, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ALXN2420
    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.
  • Placebo Comparator: Placebo
    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.
  • Experimental: Open-label Extension Period
    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.

Primary Outcome Measure

Percentage Change From Baseline in Serum IGF-1 Level at Week 15 [ Time Frame: Baseline, Week 15 ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Research SiteLos AngelesCalifornia90048-
Research SiteLos AngelesCalifornia90095-
Research SiteTorranceCalifornia90502-
Research SiteAuroraColorado80045-
Research SiteBostonMassachusetts02114-
Research SiteAnn ArborMichigan48109-
Research SiteLas VegasNevada89148-
Research SiteNew YorkNew York10032-
Research SitePortlandOregon97239-

Find similar trials in Los Angeles, CA

By research site
Research Site· Los Angeles, CAResearch Site· Torrance, CAResearch Site· Aurora, COResearch Site· Boston, MAResearch Site· Ann Arbor, MIResearch Site· Las Vegas, NV

Related Studies