Acoramidis for Amyloid Cardiomyopathy

Recruiting in Palo Alto (17 mi)

+146 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Eidos Therapeutics, a BridgeBio company

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing the safety and effectiveness of acoramidis in people with a heart condition called ATTR-CM. The drug works by preventing harmful protein clumps in the heart. Participants must have completed a previous study and cannot use other specific treatments during this trial.

Research Team

Eligibility Criteria

This trial is for people who finished the AG10-301 study, understand and can sign consent forms, and agree to use effective birth control. It's not for those with certain medical conditions or sensitivities, recent heart issues or strokes, kidney problems, other clinical trials within 30 days, substance abuse history, psychiatric conditions that affect compliance, mechanical heart devices or transplants.

Inclusion Criteria

Completed 30 months of the blinded study treatment in Study AG10-301 and the Study AG10-301 Month 30 visit including assessments and procedures

I agree to use effective birth control during and 30 days after the trial.

Have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures

Exclusion Criteria

Has hemodynamic instability, that in the judgment of the Investigator, would pose too great a risk for participation in the study

Participation in another interventional clinical trial (with the exception of Study AG10-301) within 30 days prior to dosing. Participation in observational and/or registry studies should be discussed with the Medical Monitor

I am not taking any medications that are not allowed in the study.

See 9 more

Treatment Details

Interventions

Acoramidis (AG10) (Transthyretin Stabilizer)

Trial OverviewThe trial tests Acoramidis (AG10) in patients with Transthyretin Amyloid Cardiomyopathy who completed a previous Phase 3 trial. It's an open-label extension meaning everyone knows they're getting AG10 and it focuses on long-term safety monitoring of the drug.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: AG10Experimental Treatment1 Intervention

Open-label study all participants will receive AG10 during this study.