NCT07695701

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
52mo left

Started Jul 2026

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Jul 2026Nov 2030

Study Start

First participant enrolled

July 1, 2026

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

July 6, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 10, 2026

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2030

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2030

Last Updated

July 29, 2026

Status Verified

July 1, 2026

Enrollment Period

4.1 years

First QC Date

July 6, 2026

Last Update Submit

July 27, 2026

Conditions

Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)AmyloidosisAmyloid CardiomyopathyTransthyretin Amyloidosis

Keywords

amyloidosiscardiomyopathyATTR-CMAmyloidTTR

Outcome Measures

Primary Outcomes (1)

  • 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 (5)

  • To assess the effect of acoramidis on cardiac function improvement or stabilization by CMR in participants with ATTR-CM.

    Month 36

  • To assess the effect of acoramidis on cardiac function stabilization by CMR in participants with ATTR-CM.

    Month 36

  • To evaluate the effect of treatment with acoramidis on individual parameters of left ventricular systolic function by CMR in participants with ATTR-CM

    Month 36

  • To evaluate the effect of acoramidis on cardiac structure by CMR in participants with ATTR-CM

    Month 36

  • To evaluate the effect of treatment with acoramidis on cardiac amyloid burden by CMR in participants with ATTR-CM

    Month 36

Other Outcomes (1)

  • Exploratory Outcome Measure

    At Month 12, 24 and 36

Study Arms (1)

Acoramidis (AG10)

EXPERIMENTAL

Open-label study where all participants will receive acoramidis (AG10) during the study

Drug: Acoramidis (AG10) oral tablet

Interventions

Acoramidis (AG10) oral tabletDRUG

Study drug is defined as acoramidis 712 mg (equivalent to 800 mg acoramidis hydrochloride) taken orally twice daily for 36 months of open label treatment.

Acoramidis (AG10)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University in St. Louis

St Louis, Missouri, 63110, United States

RECRUITING

MeSH Terms

Conditions

AmyloidosisAmyloid Neuropathies, FamilialAmyloidosis, Hereditary, Transthyretin-RelatedCardiomyopathiesAlzheimer Disease

Interventions

attrubyTablets

Condition Hierarchy (Ancestors)

Proteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesNervous System DiseasesAmyloid NeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesAmyloidosis, FamilialMetabolism, Inborn ErrorsHeart DiseasesCardiovascular DiseasesDementiaBrain DiseasesCentral Nervous System DiseasesTauopathiesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Central Study Contacts

Medical Information

CONTACT

1-844-550-2246medinfo@bridgebio.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2026

First Posted

July 10, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

August 1, 2030

Study Completion (Estimated)

November 1, 2030

Last Updated

July 29, 2026

Record last verified: 2026-07

Locations

US(1)