A Phase 2 interventional study of XC001 and A195/placebo in Coronary Artery Disease (CAD), sponsored by XyloCor Therapeutics, Inc.. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-08-12.
Sponsored by XyloCor Therapeutics, Inc. · Phase 2, Interventional, and Treatment
This is a 26-week (with a 26-week extension) multicenter, randomized, double-blind, placebo-controlled Phase 2 study of XC001 versus placebo. Approximately 116 participants who have CAD and have been referred for revascularization by CABG and who have, according to assessment by stress imaging multiple myocardial segments that are substantially ischemic, and that are unlikely to be fully revascularized during CABG for technical reasons, including diffuse atherosclerosis, lack of conduits, or insufficient target vessels.
Patients will be randomized in a 1:1 to XC001 or placebo injections during the final stages of the CABG procedure. Patients will have a baseline CMR at day 4-6 post CABG and additional assessments in the primary study period will be performed on Day 14, and Weeks 4, 12, and 26, (and during the extension period at 52 weeks).
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's planned enrollment of 116 is close to the median of 124 across 3,006 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →XyloCor Therapeutics, Inc. is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
1. Males and females, age 18 to 80 years, inclusive, at the time of signing the ICF.
2. Has multivessel epicardial CAD and is clinically indicated for coronary revascularization that is best treated via elective (stand-alone, i.e., not associated with valve surgery) and on-pump CABG at high risk for incomplete revascularization as assessed by local cardiothoracic surgeon and independent Eligibility Review Committee (ERC).
3. by standard quantitative imaging technique of 25% to 50%. 4. Anatomical findings on coronary angiography and/or stress imaging that increase the likelihood of incomplete revascularization post-CABG and that supply LV segments determined to be ischemic on pre-operative stress imaging (detailed in the ERC Charter). These include, but are not exclusively:
a. Diffuse distal coronary artery atherosclerotic disease and/or small coronary target vessels deemed unsuitable for grafting within a major coronary artery b. Multiple segmental lesions along a defined major coronary artery c. In a major coronary artery - "missing vessel" where the vessel is not seen on an angiogram d. Major coronary arteries that are ungraftable due to a long segment of failed stents e. High likelihood of available conduits being insufficient for target lesions in major coronary arteries f. Ischemic regions identified on stress imaging that are not likely to be benefited by CABG (ischemic region greater in size than that portion of myocardium supplied by the target vessel(s) that will likely be successfully grafted). Further detailed in the ERC Charter.
5. All participants capable of procreation with their partners must agree to use a highly effective and medically accepted method of for 6 months following the study procedure (Day 1) to avoid pregnancy. This is not required of female participants who are either:
Surgically sterile (i.e., hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) at least 1 month prior to Screening 6. Female participants agree to not donate oocytes and male participants must agree not to donate sperm for 6 months following administration of protocol.
7. Capable of providing and undergoing all the required tests and procedures in the protocol.
Exclusion Criteria:
1. Any of the following:
Current mitral or aortic valvular heart disease requiring mechanical intervention anticipated during the study period (including percutaneous intervention).
2. Participants with uncontrolled coagulation disorder (that cannot be corrected by pharmacotherapy).
3. Participants with documented, active proliferative retinopathy from any cause (ETDRS [Early Treatment Diabetic Retinopathy Study] score >35).
4. Indication for combination of CABG with any valvuloplasty or valvular replacement and/or arrhythmia surgery (for instance a Cox-maze IV surgical procedure for atrial fibrillation).
5. (BMI) > 45 kg/m2. 6. \< 10 g/dL, \< 1.2 × 103 per µL, count \< 75,000 per µL, and aspartate aminotransferase > 3 × (ULN), total > 2 × ULN unless the participant has a previously known history of Gilbert's syndrome 7. Diabetic individuals with glycosylated hemoglobin () > 9.5% or with active proliferative diabetic retinopathy.
8. A history or evidence of (HIV) or active virus (HCV), active virus (HBV).
9. Severely immune compromised participants, including participants currently treated with chronic high dose of therapy and/or cytostatic (oncolytic) therapy.
10. Diagnosis of, or treatment for, any cancer within the last 5 years, except for basal or squamous cell carcinoma or carcinomas in situ where surgical excision was considered curative. Past medical history of cancer is not exclusionary as long as the participant has been disease free for at least 5 years since the time of diagnosis and treatment.
11. Known or any other to the formulation buffer used to suspend the viral vector or contrast agents used in any of the radiographic procedures, or contraindication to general anesthesia.
12. Pregnancy or currently lactating. 13. Absolute contraindication to CMR: metallic implant (including pacemaker, or implantable cardioverter defibrillator), uncontrolled claustrophobia, severe renal dysfunction (\<30 mL/minute/1.73 m2), or on renal dialysis.
14. Recurrent or persistent atrial fibrillation with rapid ventricular response (>100 bpm) that precludes the analysis of CMR stress imaging (to assess ischemic burden, cardiac dimensions and cardiac function).
15. Receiving an intervention or participating in another clinical study within 30 days or within 5 half-lives (whichever is longer) of the drug prior to Screening. An exception may be made if the individual is enrolled in a nontherapeutic observational study (registry) or the observational portion of a therapeutic study where the sponsoring authority authorizes enrollment.
16. Prior participation in any gene therapy; however, if the study was unblinded or documentation otherwise exists that the participant was randomized to the placebo control group and did not receive active gene transfer agent, the participant may be considered for this study.
17. Has a serious or unstable medical (including unstable under adequate treatment) or psychological condition (including drugs or alcohol abuse) that, in the opinion of the Investigator (with input from the ERC as appropriate), would compromise the participant's safety or successful participation in the study or interpretation of study results.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Administration of study drug (XC001) at the end of the CABG procedure.
Drug: XC001
Administration of A195/placebo at the end of the CABG procedure.
Drug: A195/placebo
22 injections will be administered at the end of the CABG procedure as a one time treatment.
22 injections of A195/placebo will be administered at the end of the CABG procedure.
Change from Baseline (Day 4-6 CMR) in treated segment(s) comparing XC001 and placebo in CMR imaging parameters at Weeks 12 and 26 post-surgery.
Endpoint at the participant level is the proportion of qualifying segments that improve at 12 and/or 26 weeks as determined by myocardial ischemic burden, as measured by the following: * Global and segmental perfusion measured as sum of 32 subsegmental American Heart Association (AHA) LV segments with myocardial ischemia at 12- and 26-weeks follow-up compared to baseline (defined as a subsegment with myocardial ischemia without subendocardial late gadolinium enhancement) * Segmental myocardial blood flow measuring extent of ischemic defect in each of 16 (combined subendocardial and subepicardial) AHA LV segments defined as below at 12 and 26 weeks follow-up compared with Baseline: * Segment is abnormal if one (subendocardial) or both subsegments are ischemic at Baseline * Segment is defined as improved at follow-up if one or both subsegments normalize To qualify for analysis of the primary endpoint, at least 3 of 32 subsegments will have will have to be ischemic on the baseline CMR.
Time frame: Week 26
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Aug 2025; primary completion for Dec 2026, 16 months later.
Of 26 industry-sponsored phase 2 interventional studies under Coronary Artery Disease, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 29. This study's planned 16 months is close to that.
Counting every sponsor, half of 55 studies reached it within 28 months; a quarter within 16 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Encoberminogene rezmadenovec
XyloCor Therapeutics, Inc.