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NCT04988386 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Amyloid Cardiomyopathy, Transthyretin-Related, sponsored by Eidos Therapeutics, a BridgeBio company.

Active
Registry status
Phase 3
Development phase
389
Enrollment target
20
Study locations

NCT04988386: Active Phase 3 study of Amyloid Cardiomyopathy, Transthyretin-Related, sponsored by Eidos Therapeutics, a BridgeBio company.

NCT04988386 is a Phase 3 study of Amyloid Cardiomyopathy, Transthyretin-Related that is active but no longer recruiting, run by Eidos Therapeutics, a BridgeBio company. The registered enrollment target is 389 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (50% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04988386, a Phase 3 study of Amyloid Cardiomyopathy, Transthyretin-Related, is active but no longer recruiting, sponsored by Eidos Therapeutics, a BridgeBio company.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
389 participants
Enrollment target
20
Study locations

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)

Primary Outcome

Incidence of each treatment-emergent adverse events measured over 60 Months or study completion

Interventions

  • DRUG Acoramidis (AG10)

Study Locations (20)

New York

  • New York University Langone Health - New York
  • Columbia University Irving Medical Center - New York
  • Laurelton Heart Specialists - Rosedale
  • Montefiore Medical Center at Hutchinson - The Bronx

Illinois

  • Northwestern University - Chicago
  • University of Chicago Medical Center - Chicago
  • NorthShore University Health System - Evanston

Missouri

  • Saint Luke's Hospital of Kansas City - Kansas City
  • Washington University - St Louis

Pennsylvania

  • Penn Presbyterian Medical Center - Philadelphia
  • University of Pittsburgh Medical Center (UPMC) - Pittsburgh

California

  • Cedars-Sinai Medical Center - Los Angeles

Colorado

  • University of Colorado Hospital - Anschutz Medical Campus - Aurora

Maryland

  • MedStar Medical Group Cardiology at Franklin Square - Baltimore

Massachusetts

  • Boston University Medical Center General Clinical Research Unit - Boston

Trial Details

FieldValue
Enrollment Target 389 participants
Start Date 2021-10-27
Est. Completion 2028-05-15
Phase Phase 3

What the registry record for NCT04988386 still lists

NCT04988386 is an interventional study that assigns participants to a tested intervention. The registered 389 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (50% lower).

The record links to 1 condition, with Amyloid Cardiomyopathy, Transthyretin-Related appearing as the primary indexed condition, and to 1 intervention - of which Acoramidis (AG10) is the first listed.

NCT04988386 names 20 study sites across 13 states, led by New York, Illinois, Missouri.

Frequently Asked Questions

What is clinical trial NCT04988386 about?

NCT04988386 is a clinical study titled "Open-Label Safety Study of Acoramidis (AG10) in Symptomatic ATTR Participants". 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)

What is the current status of trial NCT04988386?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 389 participants. The study started on 2021-10-27. Estimated completion is 2028-05-15.

What conditions does trial NCT04988386 study?

This clinical trial studies the following conditions: Amyloid Cardiomyopathy, Transthyretin-Related.

What interventions are being tested in trial NCT04988386?

The interventions under investigation include: Acoramidis (AG10) (DRUG).

Who is sponsoring clinical trial NCT04988386?

This trial is sponsored by Eidos Therapeutics, a BridgeBio company, which has 6 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04988386 being conducted?

This trial has 20 study locations across California, Colorado, Illinois, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT04988386's enrollment target sits among peer trials

389 973rd of 2000 higher than 1,028 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04988386, the US trial registry maintained by the National Library of Medicine. NCT04988386 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.