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Study of AG10 in Amyloid Cardiomyopathy

NCT03458130 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2022-11-16

Study results available
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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.

Conditions

  • Familial ATTR-CM (ATTRm-CM, or FAC)
  • Wild-type ATTR-CM (ATTRwt-CM)

Interventions

DRUG

AG10

TTR stabilizer

DRUG

Placebo Oral Tablet

Nonactive control

Sponsors & Collaborators

  • Eidos Therapeutics, a BridgeBio company

    lead INDUSTRY

Principal Investigators

  • MARK MCGOVERN, RN · Eidos Therapeutics, a BridgeBio company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-27
Primary Completion
2018-10-05
Completion
2018-10-05
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03458130 on ClinicalTrials.gov