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

NCT07251556 | Not Yet Recruiting Phase 4

• 1 other identifier: GLP-1
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Psoriasis Arthritis

Outcome Measures

Primary Outcomes (1)

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

  carotid artery intima media thickness by ultrasound

  24 weeks

Secondary Outcomes (11)

• Carotid plaque progression

  24 weeks

• total plaque area (TPA)

  24 weeks

• BMI

  24 weeks

• waist circumferences

  24 weeks

• sugar profile

  24 weeks

Study Arms (2)

semaglutide

EXPERIMENTAL

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.

Drug: Semaglutide 0.5 mg; Drug: Semaglutide 1.0 mg; Drug: Semaglutide 0.25 mg

Control

OTHER

No active drug administered

Other: No intervention

Interventions

Semaglutide 0.5 mg DRUG

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

Also known as: ozempic

semaglutide

Semaglutide 1.0 mg DRUG

1.0 mg once weekly for 16 weeks

Also known as: ozempic

semaglutide

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.

Also known as: ozempic

semaglutide

No intervention OTHER

No intervention

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• fulfill the ClASsification criteria for Psoriatic Arthritis,
• are rheumatoid factor negative,
• BMI \>=25 kg/m2,
• are over 18 years old and
• Chinese subjects

You may not qualify if:

• have prior therapy with GLP-1 receptor agonists during the last 24 weeks,
• have pre-existing diabetes,
• have liver or renal impairment,
• have known or symptoms suggestive of CVD,
• have chronic or previous acute pancreatitis,
• have current malignancy,
• are pregnant, breastfeeding or of childbearing potential, or
• are unable to give written informed consent.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

MeSH Terms

Interventions

semaglutide

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: November 26, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 2, 2025

Record last verified: 2025-11