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

Conditions

• Psoriasis Arthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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

Study Details

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.

Key Dates

Start date

Dec 1, 2025

Status verified

Nov 2025

Primary completion

Jan 1, 2027

Completion

Jan 1, 2027

Study Design

Enrollment

40 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: semaglutide
  Patients in the treatment group will be started on an 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. Then 4 weeks the dose will be increased to 0.5 mg once weekly. After 8 weeks the dose will be increased to 1.0mg once weekly for a total treatment period of 24 weeks.
• Other: Control
  No active drug administered

Primary Outcome Measure

Difference in the proportion of subjects with CIMT between the semaglutide group and control group over a period of 24 weeks. [ Time Frame: 24 weeks ]