Cardiac Magnetic Resonance and Echocardiography Study Wit... | NCT07695701

Studies
Cardiac Magnetic Resonance and Echocardiography Study With Acoramidis

NCT07695701

Sponsor

Eidos Therapeutics, a BridgeBio company

Status

Not yet recruiting

Last Update Posted

Jul 10, 2026Actual

Enrollment

150Estimated

Phase

Phase 4

Conditions

Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)
Amyloidosis
Amyloid Cardiomyopathy
Transthyretin Amyloidosis

Interventions

Acoramidis (AG10) oral tablet

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2026-526068-19-00	EU Trial (CTIS) Number
U1111-1339-5700	Other Identifier	WHO UTN

Status Module

Record Verification Date

Jul 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2026Estimated

Primary Completion Date

Aug 2030Estimated

Completion Date

Nov 2030Estimated

First Submitted Date

Jul 6, 2026

First Submission Date that Met QC Criteria

Jul 6, 2026

First Posted Date

Jul 10, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 6, 2026

Last Update Posted Date

Jul 10, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study aims to evaluate the effect of acoramidis on cardiac functional and structural improvement in participants with ATTR-CM.

Detailed Description

Study AG10-404 is an open-label study to investigate the long-term effects of acoramidis on cardiac functional and structural improvement, and the effects on cardiac amyloid burden in participants with ATTR-CM using two types of imaging, cardiac MRI and echocardiograms to track changes in heart structure and amyloid buildup over time.

Up to approximately 150 participants (ages 18-80) will be enrolled. Participants will receive study drug (712mg equivalent to 800mg of acoramidis hydrochloride) orally twice daily from Day 1 through Month 36. The study duration for an individual participant is approximately 38 months, including up to 45 days for screening, 36 months for open-label treatment and 1 month follow-up after the last dose of study drug. In-clinic visits will occur at Day 1, Day 28, Month 6, and every 6 months up to Month 36. Phone visits will occur at Month 3 and every 6 months thereafter up to Month 33. Participants will be followed throughout their participation in this study and for 30 days (+7 days) after the last dose of study drug.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Acoramidis (AG10)	Experimental	Open-label study where all participants will receive acoramidis (AG10) during the study	Drug: Acoramidis (AG10) oral tablet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Acoramidis (AG10) oral tablet	Drug	Study drug is defined as acoramidis 712 mg (equivalent to 800 mg acoramidis HCl) taken orally twice daily for 36 months of open label treatment.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To assess the effect of acoramidis on cardiac function improvement by CMR in participants with ATTR-CM.	Change from baseline in left ventricular ejection fraction (LVEF) or left ventricular stroke volume index (LVSVi) at Month 36.	Month 36

Secondary Outcomes

Measure	Description	Time Frame
To assess the effect of acoramidis on cardiac function improvement or stabilization by CMR in participants with ATTR-CM.	Change from baseline in LVEF and LVSVi at Month 36	Month 36
To assess the effect of acoramidis on cardiac function stabilization by CMR in participants with ATTR-CM.

Other Outcomes

Measure	Description	Time Frame
Exploratory Outcome Measure	To evaluate the effect of acoramids on various biomarkers and cardiac thansthoracic echocardiogram	At Month 12, 24 and 36

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

Participants aged 18 to 80
Confirmed diagnosis of ATTR-CM requiring targeted therapy
At screening: New York Heart Association (NYHA) Class I/II; estimated glomerular filtration rate (eGFR) ≥40 mL/min/1.73m2; left ventricular ejection fraction (LVEF) >35%; left ventricular (LV) wall thickness ≥12 mm.
Heart failure condition has been clinically stable for at least 6 weeks prior to screening.

Key Exclusion Criteria:

Current or planned implantation of a cardiac implantable electronic device (eg, pacemaker, implantable cardiac defibrillator).
Acute myocardial infarction, acute coronary syndrome or coronary revascularization, or experienced stroke or transient ischemic attack within 90 days prior to screening.
Hemodynamic instability.
Likely to undergo heart transplantation within 12 months from screening.
Confirmed diagnosis of AL amyloidosis at screening.
At screening: NYHA Class III/IV; National Amyloidosis Center (NAC) Stage 3.
Prior or current treatment with acoramidis.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Medical Information	Contact	1-844-550-2246		medinfo@bridgebio.com

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000686	Amyloidosis
D028227	Amyloid Neuropathies, Familial
C567782	Amyloidosis, Hereditary, Transthyretin-Related
D009202	Cardiomyopathies
D000544	Alzheimer Disease

Ancestor Terms

ID	Term
D057165	Proteostasis Deficiencies
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D020271	Heredodegenerative Disorders, Nervous System

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
C000731204	attruby
D013607	Tablets

ID	Term
D004304	Dosage Forms
D004364	Pharmaceutical Preparations