AG10 for Cardiomyopathy

Recruiting at 8 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Eidos Therapeutics, a BridgeBio company

Must not be taking: Diflunisal, Tafamidis, others

Disqualifiers: Hemodynamic instability, Heart transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 21

55 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

You may need to stop taking certain medications like diflunisal, tafamidis, green tea, doxycycline, TUDCA/Ursodiol, patisiran, inotersen, or any other investigational ATTR agent at least 14 days before starting the study drug. The trial does not specify stopping other medications, but it's best to discuss with the study team.

What is the purpose of this trial?

This prospective, multicenter open-label study will evaluate the long-term safety, tolerability, PK and PD of AG10 administered on a background of stable heart failure therapy.

Eligibility Criteria

This trial is for patients with cardiomyopathy who have completed a prior AG10 study. Participants must be stable enough to follow the treatment plan and agree to use contraception if necessary. Those at risk of heart transplant, on certain other treatments, or with significant health risks are excluded.

Inclusion Criteria

I understand the study and have given my consent to participate.

Completed participation in study AG10-201

Willing and able to comply with the study medication regimen and all study requirements

Exclusion Criteria

Your blood tests show dangerous abnormalities that could be risky for you.

You are allergic to the study drug AG10 or any of its ingredients.

You might need a heart transplant or a mechanical heart device in the next year.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Open-Label Extension

Participants receive AG10 on a background of stable heart failure therapy, with visits at Day 14, Day 45, 3 Months, and every 3 months thereafter until Month 54

54 months

Visits at Day 14, Day 45, 3 Months, and every 3 months until Month 54

Long-term Follow-up

Participants are monitored for safety and effectiveness after treatment, with visits every 6 months after Month 54

6 months

Visits every 6 months

Final Follow-up

One follow-up visit approximately 30 days after the last dose

1 month

1 visit (in-person)

Treatment Details

Interventions

• AG10

Trial Overview The study tests the long-term safety and effects of AG10 in individuals with cardiomyopathy while they continue their usual heart failure therapy. It's an open-label trial, meaning both researchers and participants know what treatment is being given.

Participant Groups

Group I: Open-Label Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Eidos Therapeutics, a BridgeBio company

Lead Sponsor

Trials

12

Recruited

2,400+