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Clinical Trials in the USA / NCT03536767
Active, not recruiting Phase 2

Open-Label Study of AG10 in Patients with Cardiomyopathy

NCT03536767 · tracked via the Priya Life Science USA tracker
Sponsor
Eidos Therapeutics, a BridgeBio company
Phase
Phase 2
Started
2018-08-08
Last updated
2025-03-13

Condition(s) studied

Amyloid Cardiomyopathy

Investigational drug(s) / intervention(s)

AG10

AG10: AG10 800mg twice daily, oral administration

Study summary

This prospective, multicenter open-label study will evaluate the long-term safety, tolerability, PK and PD of AG10 administered on a background of stable heart failure therapy.

Eligibility

Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
Inclusion Criteria: 1. Completed participation in study AG10-201. 2. Willing and able to comply with the study medication regimen and all study requirements. 3. The ability to understand and provide informed consent, which must be obtained prior to initiation of study participation. 4. Male patients and female patients of childbearing potential who engage in heterosexual intercourse must agree to use effective method(s) of contraception. Exclusion Criteria: 1. Hemodynamic instability that would pose too great a risk to the subject. 2. Abnormalities in clinical laboratory tests that would pose too great a risk to the subject. 3. Any clinically significant ongoing medical condition or any laboratory abnormality or condition that could adversely affect the safety of the patient. 4. Known hypersensitivity to study drug (AG10), its metabolites, or formulation excipients. 5. Likely to undergo heart transplantation or placement of a mechanical circulatory device within the next year. 6. Receiving current treatment with diflunisal, tafamidis, green tea, doxycycline, TUDCA/Ursodiol, patisiran, inotersen or any other investigational ATTR agent within 14 days or 5 half-lives of the prior investigational agent (whichever is longer) prior to dosing with study drug. 7. Females who are pregnant or breastfeeding. Lactating females must agree to discontinue nursing before the study drug is administered.

Primary outcome measure(s)

Trial sites (9)

FacilityCityRegionStatus
Stanford University Palo Alto California
University of California San Francisco San Francisco California
Yale University New Haven Connecticut
Northwestern University Chicago Illinois
Brigham and Women's Hospital Boston Massachusetts
Mayo Clinic Rochester Minnesota
Columbia University New York New York
Oregon Health & Science University Portland Oregon
Medical University of South Carolina Charleston South Carolina

More Eidos Therapeutics, a BridgeBio company trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03536767 on ClinicalTrials.gov ↗ ← All trials in the USA