EXCEL-CLTI

Not yet recruiting

Expression of GLP1 Receptor on Peripheral Blood Mononuclear Cells in Advanced Peripheral Artery Disease: Paving the Way for GLP1R Agonists Treatment in Chronic Limb Threatening Ischemia

Lead sponsor

University Hospital, Strasbourg, France

Asset

GLP-1 / incretin class catch-all

Listed sites

Recruiting sites

Estimated enrollment

Study population

Eligibility highlights

Primary endpoint

•Level of GLP-1 Receptor (GLP-1R) Gene Expression in PBMCs

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07340112

Org study ID9908

Timeline

Milestones

Study first posted2026-01-14actual

Last update posted2026-01-14actual

Study start2026-06estimated (month precision)

Primary completion2028-06estimated (month precision)

Study completion2028-06estimated (month precision)

Assets

Investigational agents

GLP-1 / incretin class catch-all

Who can enroll

Minimum age40 Years

SexAll

Healthy volunteersNot accepted

Sampling methodNon probability sample

Study population text

Study participants will be recruited from the patient population managed at the Strasbourg University Hospital (CHU de Strasbourg), France. The cohort consists of individuals referred to the vascular surgery and vascular medicine departments for specialized tertiary care. Participants are identified and enrolled during their scheduled medical or surgical hospitalizations, including both outpatient day-hospital units and conventional inpatient wards. The population represents a real-world clinical sample of symptomatic patients undergoing standardized diagnostic or therapeutic evaluations for peripheral arterial conditions.

Inclusion criteria

•Patients aged 40 years or older

•Documented Peripheral Artery Disease (PAD): Patients must fall into one of the two following severity groups:

1. Intermittent Claudication (IC) Group: Defined by a maximum walking distance limited by intermittent claudication, associated with an Ankle-Brachial Index (ABI) < 0.9 at rest.

2. Chronic Limb-Threatening Ischemia (CLTI) Group: Defined by ischemic rest pain and/or tissue loss (ulcers or gangrene) persisting for at least 15 days, associated with a toe pressure or a transcutaneous oxygen tension (tcPO2) < 30 mmHg, according to the 2024 ESC guidelines.

Exclusion criteria

•Diabetes Mellitus: Diagnosis of Type 1 or Type 2 diabetes

•Current Specific Pharmacotherapy: Ongoing treatment with SGLT2 inhibitors (SGLT2i) or GLP-1 receptor agonists (GLP-1RA).

•Infection: Presence of sepsis or an active systemic infection.

•Malignancy: Active cancer or hematologic malignancies.

•Immunosuppression: History of organ transplantation or autoimmune diseases currently requiring immunosuppressive therapy.

•Known chronic inflammatory diseases.

•Advanced Renal Failure: End-stage renal disease requiring dialysis.

Endpoints (3)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Cardiometabolic biomarkers

1 endpoint

Secondary/protocol endpoint

Systemic Pro-inflammatory Cytokine Profile

Time frame:Day 1

descriptive

Other (unclassified)

2 endpoints

Primary/protocol endpoint/low confidence

Level of GLP-1 Receptor (GLP-1R) Gene Expression in PBMCs

Time frame:Day 1 (at the time of the one-time blood sampling)

descriptive

Secondary/protocol endpoint/low confidence

Oxidative and Nitrosative Stress Markers in PBMCs

Time frame:Day 1

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.