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Investigational Trial for XC001 in Chronic Angina

This study is testing a treatment called XC001, delivered directly to the heart using a special catheter (a thin, flexible tube). It's for people aged 18 to 85 who have chronic angina (chest pain) due to coronary artery disease (blocked heart arteries) that hasn't improved with other treatments and can't be fixed with surgery or stents. The study aims to see if XC001 can improve your condition. Success will be measured by a combination of factors after 6 months. The study is currently unclear about its recruitment status, but it plans to enroll 106 participants. Some participants will receive XC001, while others will have a "sham" procedure, which mimics the treatment procedure without delivering the actual drug.

Study design
This is a two-part study. The first part involves 3 participants to check safety, followed by a larger, randomized, double-blind study where 106 participants will either receive XC001 or a sham procedure.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 6 months after the treatment.

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NCT07048808

Investigational Trial to Evaluate XC001 Delivered Via an Cardiac Catheter in Subjects With Chronic Angina.

Recruiting
PHASE2Ages 18–85InterventionalTreatment
XyloCor Therapeutics, Inc.
~106 participants
Updated 2025-08-03 on ClinicalTrials.gov
What's tested:XC001Sham (No Treatment)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Composite endpoint
Measured over 6 months

Conditions

Refractory Angina
Coronary Artery Disease

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Coronary Artery DiseaseRefractory angina

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Tim Henry, MD · PRINCIPAL_INVESTIGATOR · Christ Hospital

Who to contact

Dawn VP Clinical Operation, MSc.
[email protected]
888-290-0081
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Postmenopausal (defined as no menses for 12 months without an alternative medical cause) prior to screening. In addition, at least 2 high follicle stimulating hormone (FSH) measurements in the postmenopausal range must be used to confirm a postmenopausal state in women with less than 12 months of amenorrhea and not using hormonal contraception or hormonal replacement therapy; OR
Surgically sterile (i.e., hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) at least 1 month prior to Screening 10. Female subjects agree to not donate oocytes and male subjects must agree not to donate sperm for 6 months following administration of the investigational product (IP). 11. Capable of providing informed consent and undergoing all the required tests and procedures in the protocol.

What this trial measures

  • Composite endpoint6 months

    The primary objective of this study is to evaluate the effect of XC001 on a composite endpoint of a) TED from a graded treadmill test (ETT), as assessed by a core lab, b) angina frequency from a diary (extracting the 2 weeks prior to the Week 12 and Week 26 visit) and c) ischemic burden, as quantified by stress imaging by PET (as assessed by a core lab) at 12 and 26 weeks following a one-time endocardial administration to CAD patients with RA compared to the sham procedure.