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
Qualifiers
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
Treatments tested in this trial
- Semaglutide (Rybelsus®)
- Placebo
Treatment groups
62 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov