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Open-Label Safety Study of Acoramidis (AG10) in Symptomatic ATTR Participants

NCT04988386 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 389

Last updated 2025-10-14

No results posted yet for this study

Summary

Open-Label Extension and Safety Monitoring Study of Acoramidis (AG10) in Participants with Symptomatic Transthyretin Amyloid Cardiomyopathy Who Completed the Phase 3 ATTRibute-CM Trial (AG10-301)

Conditions

  • Amyloid Cardiomyopathy, Transthyretin-Related

Interventions

DRUG

Acoramidis (AG10)

Acoramidis (AG10) twice daily

Sponsors & Collaborators

  • Eidos Therapeutics, a BridgeBio company

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-27
Primary Completion
2028-04-15
Completion
2028-05-15
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Czechia
  • Denmark
  • Greece
  • Ireland
  • Israel
  • Italy
  • Netherlands
  • New Zealand
  • Portugal
  • South Korea
  • Spain
  • United Kingdom

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 NCT04988386 on ClinicalTrials.gov