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A 26-Week (with 26 Week Extension) Randomized, Multi-Center, Double-Blind Phase 2 Study to Evaluate the Efficacy and Safety of XC001 Gene Therapy as an Adjunct to Coronary Artery Bypass Graft Surgery for Patients with Symptomatic Coronary Artery Disease with Left Ventricular Dysfunction at Risk for Incomplete Revascularization

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-521325-33-00
Acronym
XC001-1003
Enrollment
90
Registered
2025-11-11
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic angina and left ventricular dysfunction due to coronary artery disease that is considered high risk for incomplete revascularization via coronary artery bypass grafting

Brief summary

Change from Baseline (post-CABG at Day 4-6) in treated segment(s) comparing XC001 and placebo in CMR imaging parameters at Weeks 12 and 26 post-surgery. The 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 (see details in the Protocol).

Detailed description

Change from Baseline (post-CABG at Day 4-6) in treated segment(s) comparing XC001 and placebo in CMR parameters at 12 and 26 weeks, as well as at 52 weeks (during the extension period) (unless stated otherwise). Baseline CMR is defined as CMR analysis at Day 4-6 post-CABG (see details regarding CMR parameters in the Protocol).

Interventions

DRUGDiluent A195
DRUGGADOBUTROL
DRUGADENOSINE
DRUGREGADENOSON
DRUGXC001

Sponsors

Xylocor Therapeutics Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change from Baseline (post-CABG at Day 4-6) in treated segment(s) comparing XC001 and placebo in CMR imaging parameters at Weeks 12 and 26 post-surgery. The 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 (see details in the Protocol).

Secondary

MeasureTime frame
Change from Baseline (post-CABG at Day 4-6) in treated segment(s) comparing XC001 and placebo in CMR parameters at 12 and 26 weeks, as well as at 52 weeks (during the extension period) (unless stated otherwise). Baseline CMR is defined as CMR analysis at Day 4-6 post-CABG (see details regarding CMR parameters in the Protocol).

Countries

Germany, Hungary, Netherlands, Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026