Effects of Semaglutide on Clinical Outcomes and Metabolic Inflammation in Psoriasis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital Universitario Dr. Jose E. Gonzalez
About this trial
This study will evaluate the effects of oral semaglutide in combination with topical corticosteroid/calcipotriol on clinical outcomes and metabolic inflammation in patients with plaque psoriasis and overweight/obesity and/or type 2 diabetes mellitus. A total of 62 participants will be randomized to receive either semaglutide plus topical corticosteroid/calcipotriol or placebo plus topical corticosteroid/calcipotriol for 12 weeks. Clinical efficacy will be assessed using the Psoriasis Area and Severity Index (PASI), and quality of life will be evaluated using DLQI, PROMIS-29, and EQ-5D-5L. Systemic inflammatory markers will also be measured to assess metabolic inflammation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female participants aged ≥18 years at the time of randomization.
Clinical diagnosis of plaque psoriasis with Psoriasis Area and Severity Index (PASI) ≥3 and body surface area (BSA) ≥3%.
Body mass index (BMI) ≥25 kg/m², consistent with overweight or obesity.
Participants with or without type 2 diabetes mellitus.
Disqualifiers
Diagnosis of a non-plaque psoriasis subtype, including pustular, guttate, nail, inverse, psoriatic arthritis, or erythrodermic psoriasis.
Pregnancy or breastfeeding at the time of screening or enrollment.
Insulin-dependent diabetes mellitus or current use of sulfonylureas.
Active malignancy at the time of screening.
Trial design
Design model
Parallel
Treatments tested in this trial
Semaglutide (Rybelsus®)
DrugOral semaglutide will be administered once daily at a dose of 3 mg for the first 4 weeks, followed by 7 mg once daily for the next 4 weeks, and 14 mg once daily for the final 4 weeks (total treatment duration: 12 weeks). All participants will also receive conventional topical therapy for 12 weeks, consisting of a topical corticosteroid and a vitamin D analog (calcipotriol).
Placebo
DrugA total of 31 participants will be randomly assigned to the placebo intervention group. They will receive a daily placebo tablet containing starch for 12 weeks. All participants will also receive conventional topical therapy for 12 weeks, consisting of a topical corticosteroid and a vitamin D analog (calcipotriol).
Treatment groups
62 Participants
are divided into 2 treatment groupsGroup A: Semaglutide groupActive comparator 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Effect of GLP-1 Receptor Agonists on SCD-1 Activity
Change in SCD-1 activity, assessed via acylcarnitine profile (µmol/L), from baseline to Week 12.
Time frame
Baseline to Week 12Secondary outcomes
1
Proportion of Participants Achieving Psoriasis Area and Severity Index (PASI) 75
The proportion of participants achieving a 75% reduction from baseline in the Psoriasis Area and Severity Index (PASI 75) will be compared between the semaglutide and placebo groups. The Psoriasis Area and Severity Index (PASI) is a validated clinical severity score that ranges from 0 to 72, with higher scores indicating more severe psoriasis. Achievement of PASI 75 represents a clinically meaningful improvement in disease severity.
Time frame
Weeks 4, 8, and 122
Change in Body Weight
Change in body weight (kilograms) from baseline to Week 12 will be compared between the semaglutide and placebo groups.
Time frame
Baseline and Week 123
Change in Fasting Plasma Glucose
Change in fasting plasma glucose (mg/dL) from baseline to Week 12 will be compared between the semaglutide and placebo groups.
Time frame
Baseline and Week 124
Change in Total Cholesterol
Change in serum total cholesterol (mg/dL) from baseline to Week 12 will be compared between the semaglutide and placebo groups.
Time frame
Baseline and Week 12Sponsors and contacts
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Source ClinicalTrials.gov