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Transthyretin Stabilizer

Acoramidis for Amyloid Cardiomyopathy

Phase 3
Waitlist Available
Research Sponsored by Eidos Therapeutics, a BridgeBio company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
At the end of Study AG10-301 or at Day 1 of Study AG10-304 (or any time during the study), participant is on prohibited medication
Has confirmed diagnosis of light-chain (AL) amyloidosis at any time during Study AG10-301
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

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.

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
While specific side effects are not listed here, participants will be monitored for any adverse reactions due to Acoramidis (AG10), which could include typical drug-related side effects such as allergic reactions or issues related to its impact on amyloid cardiomyopathy.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not taking any medications that are not allowed in the study.
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I have been diagnosed with AL amyloidosis.
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I have had a heart or liver transplant, or I am on the heart transplant list.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of treatment-emergent Adverse Events [Safety and Tolerability]
Secondary study objectives
Evaluate all-cause mortality and cardiovascular mortality
Evaluate the effect of acoramidis on health-related quality of life Kansas City Cardiomyopathy Questionnaire
Evaluate the effect of acoramidis on the 6-minute walk test (6MWT)
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: AG10Experimental Treatment1 Intervention
Open-label study all participants will receive AG10 during this study.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Amyloid Cardiomyopathy include TTR stabilizers like Acoramidis (AG10) and Tafamidis, which work by binding to the TTR protein and preventing its misfolding and aggregation into amyloid fibrils. Additionally, RNA silencing therapies such as Patisiran and Inotersen reduce the production of TTR protein by targeting its mRNA, thereby decreasing the availability of misfolded monomers. Gene editing approaches, like those using CRISPR-Cas9, aim to knock out the TTR gene to prevent the production of amyloidogenic proteins altogether. These treatments are vital for patients as they address the underlying cause of amyloid deposition, thereby slowing disease progression and improving quality of life.
Inhibition of amyloid formation of amyloid β (1-42), amylin and insulin by 1,5-diazacyclooctanes, a spermine-acrolein conjugate.Amylin and Secretases in the Pathology and Treatment of Alzheimer's Disease.In vitro and in vivo models for anti-amyloidosis nanomedicines.

Find a Location

Who is running the clinical trial?

Eidos Therapeutics, a BridgeBio companyLead Sponsor
11 Previous Clinical Trials
2,028 Total Patients Enrolled
3 Trials studying Amyloid Cardiomyopathy
1,269 Patients Enrolled for Amyloid Cardiomyopathy

Media Library

Acoramidis (AG10) (Transthyretin Stabilizer) Clinical Trial Eligibility Overview. Trial Name: NCT04988386 — Phase 3
Amyloid Cardiomyopathy Research Study Groups: AG10
Amyloid Cardiomyopathy Clinical Trial 2023: Acoramidis (AG10) Highlights & Side Effects. Trial Name: NCT04988386 — Phase 3
Acoramidis (AG10) (Transthyretin Stabilizer) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04988386 — Phase 3
~212 spots leftby Apr 2028