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Transthyretin Stabilizer

acoramidis for Cardiomyopathy (ATTRibute-CM Trial)

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months and 30 months

Awards & highlights

ATTRibute-CM Trial Summary

This trial is testing a new drug, acoramidis, to see if it is safe and effective in treating people with symptomatic Transthyretin Amyloid Cardiomyopathy (ATTR-CM).

Eligible Conditions

Cardiomyopathy
Heart Disease
Amyloidosis
Amyloid Cardiomyopathy

ATTRibute-CM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months and 30 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months and 30 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months and 30 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

6-Minute Walk Test (6MWT) through Month 12

A hierarchical combination of all-cause mortality, cumulative frequency of cardiovascular-related hospitalization, change from baseline in NT-proBNP, and change from baseline in 6MWT over a 30-month fixed treatment duration

Secondary outcome measures

Assess PD effects of circulating prealbumin by in vivo biomarker stabilization through Month 30

Assess all-cause mortality

Assess safety and tolerability through Month 12

+7 more

Other outcome measures

Assess acoramidis activity across TTR mutations

Characterize PK of acoramidis

Effects of acoramidis on circulating biomarker of microvascular ischemia

+2 more

ATTRibute-CM Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: acoramidis HCl 800 mgExperimental Treatment1 Intervention

Subjects will receive acoramidis HCl 800 mg twice daily. 6MWT primary outcome will be assessed at the end of 12 months. The hierarchical combination of All-Cause mortality, cumulative frequency of cardiovascular-related hospitalizations, change from baseline in NT-proBNP levels, and change from baseline in distance walked on the 6MWT will be assessed after 30 months of treatment.

Group II: PlaceboPlacebo Group1 Intervention

Subjects will receive placebo to match twice daily. 6MWT primary outcome will be assessed at the end of 12 months. The hierarchical combination of All-Cause mortality, cumulative frequency of cardiovascular-related hospitalizations, change from baseline in NT-proBNP levels, and change from baseline in distance walked on the 6MWT will be assessed after 30 months of treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

acoramidis

2021

Completed Phase 3

~650

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Eidos Therapeutics, a BridgeBio companyLead Sponsor

9 Previous Clinical Trials

1,103 Total Patients Enrolled

Frequently Asked Questions

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

Are patients currently being sought for this particular clinical trial?

"According to the latest update on clinicaltrials.gov, this study has stopped recruiting patients as of December 9th, 2021. This was first posted on March 19th, 2019. Although this specific trial is no longer looking for candidates, there are 585 other active studies that are currently enrolling participants."

Answered by AI

What is the government's stance on acoramidis?

"Acoramidis safety data is strong, as it has undergone multiple rounds of clinical trials (Phase 3)."

Answered by AI

Are there any restrictions for those interested in participating in this research?

"Eligible patients for this research are those suffering from cardiomyopathies and between 18-90 years old. The study is looking to enroll around 510 individuals in total."

Answered by AI

At how many hospitals is this research being conducted?

"This trial has already enrolled 51 patients from locations across North America, including the University of Calgary, Montreal Heart Institute, and University of Texas Southwestern Medical Center."

Answered by AI

Does this research project preclude young adults from participating?

"According to the inclusion criteria laid out by the study, eligible patients must be aged 18-90. However, there are 105 studies for patients who fall under the age of 18 and 506 trials for those over 65 years old."

Answered by AI

What is the goal of this clinical trial?

"The sponsor for this study, Eidos Therapeutics (a BridgeBio company), has outlined the main objective of the study. This will be measured over a period of 30 months and is defined as A hierarchical combination of all-cause mortality, frequency of cardiovascular-related hospitalization, and change from baseline to Month 30 of treatment in the total distance walked in 6 minutes. In addition, there are secondary objectives which include Cardiovascular-related mortality (defined as Total number of deaths adjudicated as being related to cardiovascular causes) and Acoramidis pharmacodynamic assessments of TTR stabilization by Western Blot at Day 28 (Acoram"

Answered by AI

Recent research and studies

Current Oncology ReportsJournal

Updates in Cardiac Amyloidosis Diagnosis and Treatment

Stern, Lily K., and Michelle M. Kittleson. 2021. “Updates in Cardiac Amyloidosis Diagnosis and Treatment”. Current Oncology Reports. Springer Science and Business Media LLC. doi:10.1007/s11912-021-01028-8.

clinicaltrials.govStudy

Efficacy and Safety of AG10 in Subjects With Transthyretin Amyloid Cardiomyopathy

2019. "Efficacy and Safety of AG10 in Subjects With Transthyretin Amyloid Cardiomyopathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03860935.