← Back to Search

Myosin Inhibitor

Part A: EDG-7500 Single Dose for Hypertrophic Cardiomyopathy

Phase 2

Recruiting

Research Sponsored by Edgewise Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from screening through study completion (part a: up to 38 days; part b: up to 66 days)

Awards & highlights

Study Summary

This trial aims to investigate the safety and impact of different amounts of EDG-7500 in adults with a heart condition called obstructive hypertrophic cardiomyopathy, by giving either one dose or multiple

Who is the study for?

This trial is for adults with obstructive hypertrophic cardiomyopathy, a condition where the heart muscle becomes abnormally thick. Participants should not have other serious medical conditions and must be able to follow the study procedures.Check my eligibility

What is being tested?

The study tests different doses of EDG-7500, administered either once or multiple times, to see how safe it is and what effects it has on patients with obstructive hypertrophic cardiomyopathy.See study design

What are the potential side effects?

Potential side effects of EDG-7500 are not specified in the provided information. Typically, such drugs may cause dizziness, fatigue, changes in blood pressure or heart rhythm disturbances.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from screening through study completion (part a: up to 38 days; part b: up to 66 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from screening through study completion (part a: up to 38 days; part b: up to 66 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening through study completion (part a: up to 38 days; part b: up to 66 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of treatment-emergent adverse events

Secondary outcome measures

Change from baseline in left ventricular outflow tract (LVOT) gradient

Pharmacokinetic parameters of EDG-7500 as measured by maximum plasma concentration (Cmax)

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part B: EDG-7500 Multiple DoseExperimental Treatment1 Intervention

EDG-7500 once daily for up to 28 days.

Group II: Part A: EDG-7500 Single DoseExperimental Treatment1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Edgewise Therapeutics, Inc.Lead Sponsor

11 Previous Clinical Trials

836 Total Patients Enrolled

Medical DirectorStudy DirectorEdgewise Therapeutics, Inc.

2,777 Previous Clinical Trials

8,064,374 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals being enrolled in this research investigation?

"Indeed, data on clinicaltrials.gov indicates that this trial is actively enrolling participants. The trial was initially posted on the 4th of January 2024 and most recently updated on the 2nd of April 2024. This study aims to recruit a total of 30 individuals from a single site."

Answered by AI

Are there any available openings for patients to participate in this study?

"Indeed, as per clinicaltrials.gov data, this clinical trial is presently seeking individuals for participation. The trial was first made publicly available on April 1st, 2024 and underwent its most recent update on April 2nd, 2024. Enrollment aims to reach a total of 30 participants at one designated site."

Answered by AI

What are the risks associated with Part A: EDG-7500 Single Dose for individuals?

"Based on the trial phase, our team at Power assesses the safety of Part A: EDG-7500 Single Dose as a 2. This suggests that while there is existing safety data, efficacy evidence is lacking."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of EDG-7500 in Adult Patients With Obstructive Hypertrophic Cardiomyopathy (CIRRUS-HCM)

2024. "A Study of EDG-7500 in Adult Patients With Obstructive Hypertrophic Cardiomyopathy (CIRRUS-HCM)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06347159.

All > Hypertrophic Cardiomyopathy > Philadelphia