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To Evaluate the Long-term Safety and Tolerability of Acoramidis in Participants With Newly Diagnosed ATTR-CM (ACT-EARLY OLE)

NCT07116473 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2025-08-11

No results posted yet for this study

Summary

The AG10-504 study is an open-label extension study of acoramidis in participants with newly diagnosed transthyretin amyloid cardiomyopathy (ATTR-CM) or both ATTR-CM and transthyretin amyloid polyneuropathy (ATTR-PN).

Conditions

  • Amyloidosis in Transthyretin (TTR)
  • Amyloidosis, Familial
  • Amyloid Cardiomyopathy
  • Amyloid Cardiomyopathy, Transthyretin-Related
  • Amyloidogenic Transthyretin (ATTR) Amyloidosis
  • Heart Disease
  • Cardiomyopathies
  • Amyloidosis, Hereditary, Transthyretin-Related
  • Polyneuropathies
  • Amyloidosis

Interventions

DRUG

Acoramidis (AG10)

TTR stabilizer administered orally twice daily (BID)

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
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-30
Primary Completion
2037-11-30
Completion
2037-12-31
FDA Drug
Yes

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Entities

Diseases

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 NCT07116473 on ClinicalTrials.gov