GLP-1 Receptor Agonists in Non-diabetic Patients With Psoriatic Arthritis

What this study is testing ClinicalTrials.gov NCT07251556 ↗

Description as written by the study sponsor.

Background Psoriatic arthritis (PsA) patients are at increased risk of cardiovascular disease. Glucagon-Like Peptide-1 (GLP-1) receptor agonists are cardiovascular protective in diabetics. They have also anti-inflammatory properties. It is hypothesized GLP-1 receptor agonists can prevent the progression of atherosclerosis due to the combination of metabolic factors and disease activity control in non-diabetic PsA patients. Objectives To investigate the vascular effects of GLP-1 receptor agonists in PsA patients without diabetes. Their metabolic and anti-inflammatory roles will also be examined. Design and subjects This is a pilot randomized open-labelled trial. We plan to enroll 40 non-diabetic patients with PsA. Participants will be randomized 1:1 to either GLP-1 receptor agonist (semaglutide) or control group. Study instruments Subclinical carotid artherosclerosis is assessed by high-resolution ultrasound. Arterial stiffness is measured using pulse wave velocity by a tonometry system, and augmentation index by the SphygmoCor device. These assessments will be done at baseline and 24 weeks. Drug adversities will also be documented. Anthropometric measurements, sugar metabolism and lipid levels as well as the PsA disease activity will be monitored.

Treatments tested

• Semaglutide 0.5 mg also known as ozempic Drug

  Then 4 weeks the dose will be increased to 0.5 mg once weekly.

• Semaglutide 1.0 mg also known as ozempic Drug

  1.0 mg once weekly for 16 weeks

• Semaglutide 0.25 mg also known as ozempic Drug

  Initial dose of semaglutide 0.25 mg once weekly for 4 weeks to assess the tolerability of the drug and to minimize potential gastrointestinal side effects.

• No intervention Other

  No intervention