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NOT YET RECRUITING
NCT07251556
PHASE4

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

Sponsor: Chinese University of Hong Kong

View on ClinicalTrials.gov

Summary

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.

Official title: Effect of Glucagon-Like Peptide-1 (GLP-1) Receptor Agonists on Subclinical Atherosclerosis in Non-diabetic Patients With Psoriatic Arthritis - a Proof-of-concept Randomized Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-12-01

Completion Date

2027-01-01

Last Updated

2025-12-02

Healthy Volunteers

No

Interventions

DRUG

Semaglutide 0.5 mg

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

DRUG

Semaglutide 1.0 mg

1.0 mg once weekly for 16 weeks

DRUG

Semaglutide 0.25 mg

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.

OTHER

No intervention

No intervention