ClinicalTrials.gov record NCT07695701

Cardiac Magnetic Resonance and Echocardiography Study With Acoramidis

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

An Open-Label Study to Investigate the Long-Term Effects of Acoramidis on Cardiac Function, Structure and Cardiac Amyloid Burden in Participants With Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 4A study of a treatment that is already approved, to learn more about its long-term effects, safety or use in everyday practice.
Age18 years old to 80 years old
SexAll
LocationUnited States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Open-label study testing long-term effects of acoramidis in adults with ATTR-CM. Participants take oral acoramidis twice daily for 36 months and are followed for about 38 months in total. Heart structure, function and amyloid burden are measured by cardiac MRI and echocardiography.

What it is studying. The study is testing how taking acoramidis affects heart function, heart structure, and the amount of cardiac amyloid over time in people with ATTR-CM. Changes are measured with cardiac magnetic resonance imaging (CMR) and echocardiograms.

What the researchers hope to learn. Scientific goals are to evaluate the long-term effects of acoramidis on cardiac function (for example left ventricular ejection fraction and stroke volume index), cardiac structure (for example left ventricular mass index), and cardiac amyloid burden (for example extracellular volume) with measurements compared to baseline at Month 36.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

The study aims to evaluate the effect of acoramidis on cardiac functional and structural improvement in participants with ATTR-CM.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • Acoramidis (AG10) oral tablet

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Participants aged 18 to 80
  • Confirmed diagnosis of ATTR-CM requiring targeted therapy
  • At screening: New York Heart Association (NYHA) Class I/II; estimated glomerular filtration rate (eGFR) ≥40 mL/min/1.73m2; left ventricular ejection fraction (LVEF) >35%; left ventricular (LV) wall thickness ≥12 mm.
  • Heart failure condition has been clinically stable for at least 6 weeks prior to screening.
  • Key

Exclusion criteria

  • Current or planned implantation of a cardiac implantable electronic device (eg, pacemaker, implantable cardiac defibrillator).
  • Acute myocardial infarction, acute coronary syndrome or coronary revascularization, or experienced stroke or transient ischemic attack within 90 days prior to screening.
  • Hemodynamic instability.
  • Likely to undergo heart transplantation within 12 months from screening.
  • Confirmed diagnosis of AL amyloidosis at screening.
  • At screening: NYHA Class III/IV; National Amyloidosis Center (NAC) Stage 3.
  • Prior or current treatment with acoramidis.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

Study AG10-404 is an open-label study to investigate the long-term effects of acoramidis on cardiac functional and structural improvement, and the effects on cardiac amyloid burden in participants with ATTR-CM using two types of imaging, cardiac MRI and echocardiograms to track changes in heart structure and amyloid buildup over time. Up to approximately 150 participants (ages 18-80) will be enrolled. Participants will receive study drug (712 mg equivalent to 800 mg of acoramidis hydrochloride) orally twice daily from Day 1 through Month 36. The study duration for an individual participant is approximately 38 months, including up to 45 days for screening, 36 months for open-label treatment and 1 month follow-up after the last dose of study drug. In-clinic visits will occur at Day 1, Day 28, Month 6, and every 6 months up to Month 36. Phone visits will occur at Month 3 and every 6 months thereafter up to Month 33. Participants will be followed throughout their participation in this study and for 30 days (+7 days) after the last dose of study drug.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will take the study drug acoramidis (712 mg, equivalent to 800 mg acoramidis hydrochloride) orally twice daily for 36 months after up to 45 days of screening. In‑clinic visits are scheduled for Day 1, Day 28, Month 6, and then every 6 months through Month 36, with phone visits at Month 3 and every 6 months up to Month 33, and a follow-up visit about 1 month after the last dose. At visits you will have heart imaging tests—cardiac MRI (CMR) and echocardiograms—to track heart structure and cardiac amyloid burden, plus other study assessments required by the protocol. Total participation is about 38 months, and you will be followed for safety for approximately 30 days (+7 days) after your final dose.

How the study is structured. This is an open-label, single-group drug study: all participants receive acoramidis oral tablets (712 mg, equivalent to 800 mg acoramidis hydrochloride) twice daily for 36 months. Participants attend in-clinic visits at Day 1, Day 28, Month 6, and every 6 months to Month 36, plus phone visits at Month 3 and every 6 months up to Month 33. Cardiac MRI and echocardiograms are done at scheduled visits to track changes. There is a follow-up visit about one month after the last dose; an individual's participation lasts about 38 months including screening.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry lists this study under Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM); Amyloidosis; Amyloid Cardiomyopathy; Transthyretin Amyloidosis. Does it apply to my diagnosis?
  • The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on wild-type ATTR amyloidosis

This trial is also listed on this website under ATTRv amyloidosis.

Clinical trials121 trials listed for wild-type ATTR amyloidosisEvery trial the registry lists for wild-type ATTR amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in wild-type ATTR amyloidosis researchLatest monthly update: September 2026. Includes: Frailty and support needs. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
July 2026 (estimated)
Primary completion
August 2030 (estimated)
Study completion
November 2030 (estimated)
Target enrollment
150 participants (estimated)
Last updated on registry
Jul 29, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Eidos Therapeutics, a BridgeBio company

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

  • Washington University in St. LouisRecruiting

    St Louis, Missouri, 63110 · United States

Terms used on this page · explanations by MedicalUpdates.ai

At screening
The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
estimated glomerular filtration rate
A blood-test estimate of how well the kidneys are filtering. Lower numbers mean reduced kidney function; many studies set a minimum value.
Key Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Key Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
open-label
No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff.
MRI
A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
study drug
A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this website; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

← Back to clinical trials