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

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

First listed

May 27, 2026

Start date

Jun 11, 2026

Status verified

Jul 2026

Primary completion

Feb 6, 2029

Completion

Feb 6, 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 ]

Locations (24)

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