Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06183931

Study of ALXN2220 Versus Placebo in Adults With ATTR-CM

The primary objective of this study is to access the efficacy of ALXN2220 in the treatment of adult participants with ATTR-CM by evaluating the difference between the ALXN2220 and placebo groups as assessed by the total occurrences of all-cause mortality (ACM) and cardiovascular (CV) clinical events.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Transthyretin Amyloid Cardiomyopathy Amyloidosis Metabolic Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of ATTR-CM with either wild-type or variant TTR genotype
  • End-diastolic interventricular septal wall thickness ≥ 12 mm on echocardiography measured at Screening
  • NT-proBNP > 2000 pg/mL at Screening
  • Treatment with a loop diuretic for at least 30 days prior to Screening
  • History of heart failure NYHA Class II-IV at Screening
  • Life expectancy of ≥ 6 months as per the Investigator's judgment
  • Males and females of childbearing ability must use contraception

Exclusion criteria

  • Known leptomeningeal amyloidosis
  • Known light chain (AL) or secondary amyloidosis (AA), or any other form of systemic amyloidosis
  • Acute coronary syndrome, unstable angina, stroke, transient ischemic attack, coronary revascularization, cardiac device implantation, cardiac valve repair, or major surgery within 3 months of Screening
  • Uncontrolled clinically significant cardiac arrhythmia, per Investigator's assessment
  • LVEF < 30% on echocardiography
  • Renal failure requiring dialysis or an eGFR < 20 mL/min/1.73 m2 at Screening
  • Polyneuropathy with PND score IV

Treatment and study plan

ALXN2220

Drug

Participants will receive ALXN2220 via IV infusion.

Placebo

Drug

Participants will receive placebo via IV infusion.

Primary outcomes

  1. Total Occurrence of ACM and CV clinical events during the Blinded Treatment Period

    Time frame: Baseline up to the end study (up to Month 48)

Secondary outcomes

  1. Change From Baseline in Kansas City Cardiomyopathy Questionnaire-Overall Score (KCCQ-OS) at Month 24

    Time frame: Baseline, Month 24

  2. Time to CV-related Mortality

    Time frame: Baseline up to the end of study (up to Month 48)

  3. Change from Baseline in Six-minute Walk Test (6MWT) at Month 24

    Time frame: Baseline, Month 24

  4. Total Occurrences of CV Clinical Events

    Time frame: Baseline up to the end of study (up to Month 48)

  5. Time to ACM

    Time frame: Baseline up to the end of study (up to Month 48)

Sponsors and collaborators

Lead sponsor

Alexion Pharmaceuticals, Inc.

Industry

Registry information

Official study title

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Amyloid Depleter ALXN2220 in Adult Participants With Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

Acronym: DepleTTR-CM

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Dec 28, 2023
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.