← Trials/Trial dossier/NCT07251556
GLP-1 Receptor Agonists in Non-diabetic Patients With Psoriatic Arthritis
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
Lead sponsor
Asset
Semaglutide
GLP-1 agonist
Listed sites
0
Recruiting sites
—
Enrollment
40
estimated
Study population
Obesity / overweight, Psoriasis / psoriatic arthritis
Key I/E criterion
•BMI ≥25
Primary endpoint
•The proportion of subjects with CIMT between the semaglutide group
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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.
Endpoints (12)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
2 endpointsBMI
Time frame:24 weeks
BMI, change
change from baseline, improvement
waist circumferences
Time frame:24 weeks
Waist circumference, change
change from baseline, improvement
Glycemic / diabetes
2 endpointssugar profile
Time frame:24 weeks
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
sugar profile
Time frame:24 weeks
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Cardiometabolic biomarkers
4 endpointsDifference in the proportion of subjects with CIMT between the semaglutide group and control group over a period of 24 weeks.
Time frame:24 weeks
threshold achievement, improvement
Carotid plaque progression
Time frame:24 weeks
categorical status, improvement
lipid profile
Time frame:24 weeks
LDL-C, change
change from baseline, improvement
LOINC 13457-7
lipid profile
Time frame:24 weeks
Triglycerides, change
change from baseline, improvement
LOINC 2571-8
Safety / tolerability / PK
1 endpointOccurrence of adverse events.
Time frame:24 weeks
Treatment-emergent AEs (any)
event count, event
Other clinical outcomes
2 endpointsPsA disease activity (MDA)
Time frame:24 weeks
threshold achievement, improvement
componentsswollen joint count, tender joint count, pain vas, patient global vas, leeds enthesitis index, pasi score, haq di score
PsA disease activity (DAPSA)
Time frame:24 weeks
descriptive, improvement
componentshs-CRP, change, patient pain vas, patient global vas, swollen joint count, tender joint count
Other (unclassified)
1 endpointtotal plaque area (TPA)
Time frame:24 weeks
descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.