A Phase 3 Study of ALXN2060 in Japanese Participants With Symptomatic ATTR-CM

NCT04622046 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-01-09

Study results available
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Summary

This prospective study is designed to evaluate the efficacy, safety, and tolerability of ALXN2060 (also known as AG10), as well as to establish its pharmacokinetic and pharmacodynamic profile in Japanese participants with symptomatic ATTR-CM administered on a background of stable heart failure therapy.

Conditions

  • Symptomatic Transthyretin Amyloid Cardiomyopathy

Interventions

DRUG

ALXN2060

ALXN2060 tablets will be administered twice daily at a dose of 800 milligrams.

Sponsors & Collaborators

  • Eidos Therapeutics, a BridgeBio, Inc. Company

    collaborator UNKNOWN
  • Alexion Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-13
Primary Completion
2023-11-08
Completion
2025-08-21
FDA Drug
Yes

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04622046 on ClinicalTrials.gov