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Clinical Trials

Skeletal

Becker Muscular Dystrophy (Becker)

A Pivotal Cohort within CANYON of sevasemten in Adults with Becker

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Recruiting

Adults with Becker aged 18 to 50 years

GRAND CANYON is a global, placebo-controlled study to assess the effect of sevasemten over an 18-month period on safety and efficacy, with North Star Ambulatory Assessment (NSAA) as the primary endpoint.

A Phase 2 Trial of sevasemten in Individuals with Becker

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Active, Not Recruiting

Individuals with Becker aged 12 to 50 years

CANYON is a placebo-controlled trial to assess the effect of sevasemten over a 12-month period on safety, PK, biomarkers such as creatine kinase (CK) and functional measures.

A Study of sevasemten in Adult Males With Becker

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Completed

Adults with Becker aged 18 to 55 years old

ARCH is an open-label trial to assess the effect of escalating doses of sevasemten over 2 years on safety, PK, biomarkers of muscle damage such as CK and fast skeletal muscle troponin I, measures of function with North Star Ambulatory Assessment (NSAA) and North Star Assessment for Limb Girdle Type Muscular Dystrophies (NSAD), time function tests and patient-reported outcomes.

Duchenne Muscular Dystrophy (Duchenne)

A Phase 2 Trial of sevasemten in Children with Duchenne

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Recruiting

Children with Duchenne aged 4 to 9 years

LYNX is a placebo-controlled trial to assess the effect of different dose levels of sevasemten over 12 weeks on safety, pharmacokinetics and biomarkers of muscle damage. Study participants include boys with Duchenne on stable corticosteroids as well as a single cohort of boys not currently treated with corticosteroids. After the initial 12 weeks, LYNX participants will then continue on open-label sevasemten for an additional 21 months to gain further insights into safety and functional measures.

A Phase 2 Trial of sevasemten in Children and Adolescents with Duchenne

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Recruiting

Individuals aged 6 to 14 years with Duchenne previously treated with gene therapy

FOX is a placebo-controlled trial to assess the effect of multiple doses of sevasemten over 12 weeks on safety, pharmacokinetics and biomarkers of muscle damage. After the initial 12 weeks, FOX participants will then continue on open-label sevasemten for an additional 9 months to gain further insights into safety and functional measures.

For more information about our skeletal muscle trials, email studies@edgewisetx.com.

Sevasemten is an investigational therapy not approved in any territory.

Cardiovascular

Hypertrophic Cardiomyopathy (HCM)

A Phase 2 Trial of EDG-7500 in Adults with HCM

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Recruiting

An open label study to assess the effect of EDG-7500 on safety, tolerability, pharmacokinetics and pharmacodynamics of different doses of EDG-7500 as a single dose in adults with obstructive hypertrophic cardiomyopathy and multiple doses in adults with obstructive or nonobstructive hypertrophic cardiomyopathy.

Healthy Adults

Phase 1 Trial of EDG-7500

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Completed

A Phase 1 trial designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of EDG-7500 in healthy adults.

For more information about our cardiac trials, email cardiacstudies@edgewisetx.com.

EDG-7500 is an investigational therapy. Individuals should talk with their healthcare provider(s) to see if a clinical trial may be right for them.

Developing new therapies for people with muscle disorders.


Edgewise is committed to developing new therapies for people living with severe, genetic neuromuscular or cardiac disorders. Novel therapies require years of laboratory research and clinical testing to evaluate safety and efficacy. Volunteers who enroll in clinical trials help Edgewise evaluate the potential benefits and safety profile of these investigational therapies in humans. Additionally, investigational therapies must successfully progress through various phases of clinical research before they can be approved for use in the clinical setting.

Please click the orange buttons to learn more about our active clinical trials and see if you qualify to participate. By taking part in one of our clinical trials, you can help us make a difference for the entire community of people living with severe, genetic neuromuscular or cardiac disorders.