Clinical trial

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

Opening soon · Phase 4 · 0 countries · Registry ID NCT07251556

Opening soonPhase 4Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionPsoriasis Arthritis

Full registry criteria

Inclusion Criteria: 1. fulfill the ClASsification criteria for Psoriatic Arthritis, 2. are rheumatoid factor negative, 3. BMI \>=25 kg/m2, 4. are over 18 years old and 5. Chinese subjects Exclusion Criteria: 1. have prior therapy with GLP-1 receptor agonists during the last 24 weeks, 2. have pre-existing diabetes, 3. have liver or renal impairment, 4. have known or symptoms suggestive of CVD, 5. have chronic or previous acute pancreatitis, 6. have current malignancy, 7. are pregnant, breastfeeding or of childbearing potential, or 8. are unable to give written informed consent.

Treatments and study arms

Semaglutide 0.5 mg

Drug

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

Semaglutide 1.0 mg

Drug

1.0 mg once weekly for 16 weeks

Semaglutide 0.25 mg

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

Primary outcomes

Difference in the proportion of subjects with CIMT between the semaglutide group and control group over a period of 24 weeks.24 weeks

carotid artery intima media thickness by ultrasound

Study locations

0 locations were listed when this page was built. The first 40 are shown.

No public site location was included in this record. Check the original registry for updates.