Study of Oral Semaglutide Plus Topical Therapy to Improve Psoriasis and Metabolic Inflammation in Adults with Overweight or Type 2 Diabetes

What this Trial Is About

Researchers are evaluating the effects of oral semaglutide combined with topical corticosteroid and calcipotriol cream on clinical outcomes and metabolic inflammation in adults with plaque psoriasis who are overweight, obese, andor have type 2 diabetes. This randomized, triple-blind, placebo-controlled trial aims to study how semaglutide impacts psoriasis severity, quality of life, and systemic inflammatory markers compared to placebo. The study involves 62 participants with metabolic comorbidities linked to psoriasis severity and treatment response. Participants will be randomly assigned to receive either oral semaglutide or a placebo daily for 12 weeks. Semaglutide dosing starts at 3 mg daily for 4 weeks, then increases to 7 mg daily for 4 weeks, and finally 14 mg daily for the last 4 weeks. All participants will apply a topical corticosteroid and vitamin D analog calcipotriol cream during the treatment period. The trial includes two groups one receiving semaglutide plus topical therapy, and the other receiving placebo plus topical therapy. During the study, participants will undergo clinical assessments at baseline and weeks 4, 8, and 12. Psoriasis severity will be measured using the Psoriasis Area and Severity Index PASI, and quality of life will be assessed with the Dermatology Life Quality Index DLQI, PROMIS-29, and EQ-5D-5L questionnaires. Blood samples will be collected at baseline and week 12 to analyze metabolic and inflammatory biomarkers. The primary outcome is the effect on SCD-1 activity, with multiple secondary outcomes including changes in weight, glucose, cholesterol, inflammatory markers, and quality of life scores. Safety and adverse events will also be monitored throughout the 12-week treatment period.

Effects of Semaglutide on Clinical Outcomes and Metabolic Inflammation in Psoriasis