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COMPLETED Phase 2

Study of AG10 in Amyloid Cardiomyopathy

NCT03458130 · View on ClinicalTrials.gov ↗

Study Summary

This prospective, randomized, multicenter, double-blind, parallel group, placebo-controlled, dose-ranging study will evaluate the safety, tolerability, PK (Pharmacokinetic) and PD (Pharmacodynamic) of AG10 compared to placebo administered on a background of stable heart failure therapy. Screening and randomization will be followed by a 28-day blinded, placebo-controlled treatment period.

Interventions

  • DRUG Placebo Oral Tablet
  • DRUG AG10

Study Locations (13)

California

  • Cedars-Sinai Medical Center — Beverly Hills
  • Stanford University — Palo Alto
  • University of California San Francisco — San Francisco

Massachusetts

  • Brigham and Women's Hospital — Boston
  • Boston University — Boston

Connecticut

  • Yale University — New Haven

Illinois

  • Northwestern University — Chicago

Minnesota

  • Mayo Clinic — Rochester

New York

  • Columbia University — New York

Ohio

  • Cleveland Clinic — Cleveland

Oregon

  • Oregon Health & Science University — Portland

Trial Details

FieldValue
Enrollment Target 49 participants
Start Date 2018-04-27
Est. Completion 2018-10-05
Phase Phase 2

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03458130

The ClinicalTrials.gov registry entry for NCT03458130 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eidos Therapeutics, a BridgeBio company, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Familial ATTR-CM (ATTRm-CM, or FAC) appearing as the primary indexed condition, and to 2 interventions — of which Placebo Oral Tablet is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03458130 reports 13 study locations spanning 10 distinct geographic areas — top geographies include California, Massachusetts, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03458130 about?

NCT03458130 is a clinical study titled "Study of AG10 in Amyloid Cardiomyopathy". This prospective, randomized, multicenter, double-blind, parallel group, placebo-controlled, dose-ranging study will evaluate the safety, tolerability, PK (Pharmacokinetic) and PD (Pharmacodynamic) of AG10 compared to placebo administered on a background of stable heart failure therapy. Screening an...

What is the current status of trial NCT03458130?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 49 participants. The study started on 2018-04-27. Estimated completion is 2018-10-05.

What conditions does trial NCT03458130 study?

This clinical trial studies the following conditions: Familial ATTR-CM (ATTRm-CM, or FAC), Wild-type ATTR-CM (ATTRwt-CM). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03458130?

The interventions under investigation include: Placebo Oral Tablet (DRUG), AG10 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03458130?

This trial is sponsored by Eidos Therapeutics, a BridgeBio company, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03458130 being conducted?

This trial has 13 study locations across California, Connecticut, Illinois, Massachusetts, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial