A Study to Evaluate the Efficacy and Safety of Concomitant Use of Eplontersen and ALXN2220 Compared With Eplontersen and Placebo for Adults Participants With ATTR-CM

Part of paid clinical trials in La Jolla, California.

Sponsor
AstraZeneca
Study ID
NCT07608354
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Eplontersen — DRUG
    Eplontersen delivered subcutaneously, once every 4 weeks
  • ALXN2220 — BIOLOGICAL
    ALXN2220 delivered intravenously, once every 4 weeks
  • Placebo — OTHER
    Placebo delivered intravenously, once every 4 weeks

Study Details

The purpose of this randomised, double-blind, placebo-controlled, multicenter study is to evaluate the efficacy and safety of concomitant use of eplontersen and ALXN2220 compared with eplontersen and placebo in adult participants with Transthyretin-mediated amyloid cardiomyopathy (ATTR-CM).

Key Dates

Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Feb 23, 2029
Completion
Feb 23, 2029

Study Design

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

Arms

  • Experimental: Eplontersen and ALXN2220
    Subcutaneous eplontersen and intravenous ALXN2220 every 4 weeks
  • Placebo Comparator: Eplontersen and placebo
    Subcutaneous eplontersen and intravenous placebo every 4 weeks

Primary Outcome Measure

Cardiopulmonary exercise test peak VO2 [ Time Frame: 52 week ]

Central Contacts

Locations (24)

FacilityCityStateZIPSite coordinators
Research SiteLa JollaCalifornia92037-
Research SiteSan FranciscoCalifornia94115-
Research SiteStanfordCalifornia94305-
Research SiteAuroraColorado80045-
Research SiteWashington D.C.District of Columbia20010-
Research SiteJacksonvilleFlorida32224-
Research SiteMiamiFlorida33176-
Research SiteWestonFlorida33331-
Research SiteChicagoIllinois60637-
Research SiteBostonMassachusetts02115-
Research SiteKansas CityMissouri64111-
Research SiteSt LouisMissouri63110-
Research SiteNew YorkNew York10032-
Research SiteChapel HillNorth Carolina27599-
Research SiteDurhamNorth Carolina27710-
Research SiteClevelandOhio44195-
Research SitePortlandOregon97239-
Research SiteDanvillePennsylvania17822-
Research SitePhiladelphiaPennsylvania19104-
Research SiteGermantownTennessee38138-
Research SiteDallasTexas75390-
Research SiteHoustonTexas77030-
Research SiteSalt Lake CityUtah84132-
Research SiteFalls ChurchVirginia22042-

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