RecruitingPhase 4NCT07401992

Effects of Semaglutide on Clinical Outcomes and Metabolic Inflammation in Psoriasis

Effects of Semaglutide on Clinical Outcomes and Metabolic Inflammation in Psoriasis: A Randomized, Triple-Blind, Placebo-Controlled Clinical Trial

Sponsor

Hospital Universitario Dr. Jose E. Gonzalez

Enrollment

62 participants

Start Date

Jan 15, 2026

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus, Type 2 Obesity, Overweight Psoriasis (PsO)

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

Min Age: 18 Years

Inclusion Criteria7

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 Criteria15

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.

Interventions

DRUGSemaglutide (Rybelsus®)

Oral 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).

DRUGPlacebo

A 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).