Health TrialsbyHealthPanel

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

ConditionPsoriasis Arthritis
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorChinese University of Hong Kong

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

fulfill the ClASsification criteria for Psoriatic Arthritis,

are rheumatoid factor negative,

BMI >=25 kg/m2,

are over 18 years old and

Disqualifiers

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,

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    No intervention

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: semaglutideExperimental treatment 3 interventions
Group B: ControlOther 1 intervention

Trial outcomes

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

Time frame
24 weeks

Secondary outcomes

1

Carotid plaque progression

Plaque progression is defined as an incident plaque in a segment without plaque before or an increase in number of plaque.

Time frame
24 weeks
2

total plaque area (TPA)

For TPA, the plane for measurement of each plaque will be chosen by reviewing the video of the scan to find the largest extent of plaque as seen on the longitudinal view.

Time frame
24 weeks
3

BMI

weight in kilograms/the square of height in meters

Time frame
24 weeks
4

waist circumferences

in centimeters

Time frame
24 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chinese University of Hong Kong

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: