Recruiting

Acoramidis

Sponsor:

Eidos Therapeutics, a BridgeBio company

Code:

NCT07695701

Conditions

Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)

Amyloidosis

Amyloid Cardiomyopathy

Transthyretin Amyloidosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Acoramidis (AG10) oral tablet

Study Details

Brief summary:

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

Conditions

Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)

Amyloidosis

Amyloid Cardiomyopathy

Transthyretin Amyloidosis

Study ID

NCT07695701

Start date

Jul, 2026

Status verified date

Jul, 2026

Completion date

Nov, 2030

Anticipated

Primary completion date

Aug, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

150 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Acoramidis (AG10)

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

Interventions

Acoramidis (AG10) oral tablet

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.

Primary outcome measure

  • To assess the effect of acoramidis on cardiac function improvement by CMR in participants with ATTR-CM. [ Time Frame: Month 36 ]

Central Contacts and Locations

Central contacts

Medical Information

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

Locations

Washington University in St. Louis

Recruiting

St Louis, Missouri, United States, 63110

More Information

Sponsor

Eidos Therapeutics, a BridgeBio company

Last update posted

Jul 29, 2026

Last verified

Jul, 2026

Keywords

  • amyloidosis
  • cardiomyopathy
  • ATTR-CM
  • Amyloid
  • TTR

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-11. This information was provided to ClinicalTrials.gov by Eidos Therapeutics, a BridgeBio company on 2026-07-29. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.