Open-Label Safety Study of Acoramidis (AG10) in Symptomatic ATTR Participants

Running, not enrolling · Phase 3

Conditions studied: Amyloid Cardiomyopathy, Transthyretin-Related

In brief

Open-Label Extension and Safety Monitoring Study of Acoramidis (AG10) in Participants with Symptomatic Transthyretin Amyloid Cardiomyopathy Who Completed the Phase 3 ATTRibute-CM Trial (AG10-301)

Key facts

Study ID

NCT04988386

Run by

Eidos Therapeutics, a BridgeBio company

People needed

389

Starts

2021-10-27

Expected to finish

2028-05-15

Last updated by the study team

2025-10-14

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Completed 30 months of the blinded study treatment in Study AG10-301 and the Study AG10-301 Month 30 visit including assessments and procedures.
• Have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.
• Female participants of childbearing potential who engage in heterosexual intercourse must agree to use a highly effective method of contraception beginning with enrollment and continuing for 30 days after the last dose of acoramidis. Female participants using oral contraceptives must agree to use an additional birth control method. While not considered highly effective, a double-barrier method is acceptable. A male participant who is sexually active with a female of childbearing potential and has not had a vasectomy must agree to use a double-barrier method of birth control.

You may not qualify if…

• Acute myocardial infarction, acute coronary syndrome or coronary revascularization within 90 days prior to Day 1 stroke or transient ischemic attack (TIA) within 90 days prior to Day 1.
• Has hemodynamic instability, that in the judgment of the Investigator, would pose too great a risk for participation in the study.
• Has had a heart and/or liver transplant or is on the heart transplantation list within the year prior to Day 1
• Has had implantation of a cardiac mechanical assist device (CMAD) or is scheduled for implantation of a CMAD
• Has confirmed diagnosis of light-chain (AL) amyloidosis at any time during Study AG10-301.
• Has estimated glomerular filtration rate (eGFR) by modification of diet for renal disease (MDRD) formula < 15 mL/min/1.73 m2 at Month 27 of Study AG10-301 or at any subsequent central lab value prior to Day 1.
• Known hypersensitivity to acoramidis, its metabolites, or formulation excipients.
• At the end of Study AG10-301 or at Day 1 of Study AG10-304 (or any time during the study), participant is on prohibited medication.
• Females who are pregnant or breastfeeding. A negative urine pregnancy test at the Day 1 visit and at each study visit are required for female participants of childbearing potential.
• In the judgment of the Investigator or Medical Monitor, has any clinically important ongoing medical condition or laboratory abnormality or condition that might jeopardize the participant's safety, increase their risk from participation, or interfere with the study.
• Participation in another interventional clinical trial (with the exception of Study AG10-301) within 30 days prior to dosing. Participation in observational and/or registry studies should be discussed with the Medical Monitor.
• Has any condition that in the opinion of the Investigator or Medical Monitor would preclude compliance with the study protocol such as a history of substance abuse, alcoholism, or a psychiatric condition.

Where it is running

• University of Colorado Hospital - Anschutz Medical Campus — Aurora, Colorado, United States
• Northwestern University — Chicago, Illinois, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• NorthShore University Health System — Evanston, Illinois, United States
• MedStar Medical Group Cardiology at Franklin Square — Baltimore, Maryland, United States
• Boston University Medical Center General Clinical Research Unit — Boston, Massachusetts, United States
• Mayo Clinic - Rochester — Rochester, Minnesota, United States
• Saint Luke's Hospital of Kansas City — Kansas City, Missouri, United States
• Washington University — St Louis, Missouri, United States
• New York University Langone Health — New York, New York, United States
• Columbia University Irving Medical Center — New York, New York, United States
• Laurelton Heart Specialists — Rosedale, New York, United States
• Montefiore Medical Center at Hutchinson — The Bronx, New York, United States
• Duke University Health System - Duke Clinic — Durham, North Carolina, United States
• Cleveland Clinic Main Campus — Cleveland, Ohio, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Penn Presbyterian Medical Center — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Medical Center (UPMC) — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• University of Utah — Salt Lake City, Utah, United States
• Virginia Commonwealth University Health System — Richmond, Virginia, United States
• Roanoke Heart Institute — Roanoke, Virginia, United States
• University of Washington School of Medicine — Seattle, Washington, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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