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Open-Label Safety Study of Acoramidis (AG10) in Symptomatic ATTR Participants
NCT04988386 · View on ClinicalTrials.gov ↗
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 Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 389 participants |
| Start Date | 2021-10-27 |
| Est. Completion | 2028-05-15 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04988386
The ClinicalTrials.gov registry entry for NCT04988386 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 389 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eidos Therapeutics, a BridgeBio company, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04988386 reports 20 study locations spanning 13 distinct geographic areas — top geographies include New York, Illinois, Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04988386?
The interventions under investigation include: Acoramidis (AG10) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04988386?
This trial is sponsored by Eidos Therapeutics, a BridgeBio company, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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