Effects of Semaglutide on Clinical Outcomes and Metabolic Inflammation in Psoriasis

Summary

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

Inclusion Criteria:

* 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.
* Participants with diabetes must be on stable antidiabetic therapy (no changes in medication or dosage within the previous 3 months) and have adequate glycemic control, defined as HbA1c ≤9.0% at baseline.
* No use of systemic psoriasis therapies (e.g., methotrexate, cyclosporine) for at least 8 weeks prior to randomization.
* No use of biologic therapies for at least 3 months prior to randomization.

Exclusion Criteria:

* 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.
* History of thyroid neoplasia.
* Presence of autoimmune diseases.
* Use of systemic therapies within 8 weeks prior to randomization.
* Use of biologic therapies within 3 months prior to randomization.
* Renal insufficiency.
* Heart failure.
* Hepatic insufficiency.
* History of pancreatitis.
* Current treatment with other GLP-1 receptor agonists.
* History of inflammatory bowel disease.
* Known allergy to starch.

Conditions4

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