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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
Be older than 18 years old
Must not have
Females who are pregnant or breastfeeding. Lactating females must agree to discontinue nursing before the study drug is administered
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 months or study completion by recommendation from safety monitoring committee
Awards & highlights
No Placebo-Only Group

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.
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.
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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not pregnant or breastfeeding, or I agree to stop breastfeeding to participate.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Assessment of long-term safety and tolerability: Incidence of each treatment-emergent adverse events
Secondary study objectives
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%
Dyspnoea
6%
Groin Pain
6%
Muscle Spasms
6%
Atrial Fibrillation
6%
Constipation
100%
80%
60%
40%
20%
0%
Study treatment Arm
AG10 400mg
AG10 800mg
Placebo

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
11 Previous Clinical Trials
2,362 Total Patients Enrolled
2 Trials studying Amyloid Cardiomyopathy
1,214 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
~16 spots leftby Jul 2027