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Transthyretin Stabilizer

AG10 for Cardiomyopathy

Phase 2
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
The ability to understand and provide informed consent, which must be obtained prior to initiation of study participation
Male patients and female patients of childbearing potential who engage in heterosexual intercourse must agree to use effective method(s) of contraception
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 months or study completion by recommendation from safety monitoring committee
Awards & highlights

Study Summary

This trial will study the long-term effects of AG10 on people with heart failure.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects aren't listed here, potential risks may include reactions related to heart function or interactions with existing medications. As it's a safety study, monitoring for any adverse effects will be a key part of the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I understand the study and have given my consent to participate.
Select...
I agree to use effective birth control if there's any chance of pregnancy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 60 months or study completion by recommendation from safety monitoring committee
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 months or study completion by recommendation from safety monitoring committee for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assessment of long-term safety and tolerability: Incidence of each treatment-emergent adverse events
Secondary outcome measures
AG10 Pharmacodynamic Assessments of TTR stabilization by Fluorescent Polarization Exclusion Assay
AG10 Pharmacodynamic Assessments of TTR stabilization by Western Blot
AG10 Pharmacodynamic Assessments: prealbumin
+1 more

Side effects data

From 2018 Phase 2 trial • 49 Patients • NCT03458130
13%
Oedema Peripheral
13%
Venous Pressure Jugular Increased
13%
Diarrhoea
6%
Groin Pain
6%
Dyspnoea
6%
Muscle Spasms
6%
Atrial Fibrillation
6%
Constipation
100%
80%
60%
40%
20%
0%
Study treatment Arm
AG10 400mg
AG10 800mg
Placebo

Trial Design

1Treatment groups
Experimental Treatment
Group I: Open-LabelExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AG10
2018
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

Eidos Therapeutics, a BridgeBio companyLead Sponsor
9 Previous Clinical Trials
1,677 Total Patients Enrolled
1 Trials studying Amyloid Cardiomyopathy
632 Patients Enrolled for Amyloid Cardiomyopathy

Media Library

AG10 (Transthyretin Stabilizer) Clinical Trial Eligibility Overview. Trial Name: NCT03536767 — Phase 2
Amyloid Cardiomyopathy Research Study Groups: Open-Label
Amyloid Cardiomyopathy Clinical Trial 2023: AG10 Highlights & Side Effects. Trial Name: NCT03536767 — Phase 2
AG10 (Transthyretin Stabilizer) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03536767 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does AG10 have the green light from the FDA?

"AG10's safety is based on data from Phase 2 trials, which means that while there is some evidence to support its safety, there is none yet to suggest it is an effective medication."

Answered by AI

Are young adults eligible for this experiment?

"According to the study's eligibility requirements, patients between 18 and 90 years old are able to enroll. There are 14 clinical trials for people younger than this age bracket and 168 for those older."

Answered by AI

Are there any restrictions on who is eligible to participate in this trial?

"The ideal candidate for this trial is somebody aged 18-90 that has a cardiomyopathy. Furthermore, it is mandatory that all participants are willing and able to commit to the study medication schedule as well as other potential requirements."

Answered by AI

Is this trial looking for new participants?

"No, this particular study is not taking any more patients at the moment. The clinical trial was first posted on 8/8/2018 and was last edited on 9/15/2021 according to information found on clinicaltrials.gov. It is worth noting that there are 176 other trials presently recruiting patients."

Answered by AI

Where are the trial sites located?

"So far, this study has recruited patients from Yale University, Northwestern University, and Brigham and Women's Hospital. There are 9 other locations where researchers are looking for participants."

Answered by AI
~20 spots leftby Jul 2027