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

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

Plain Language Summary

Simplified for easier understanding

This study is testing whether semaglutide — a medication used for weight loss and diabetes — can also improve symptoms of psoriasis (a skin condition causing red, scaly patches) and reduce inflammation in overweight people. Researchers believe semaglutide's effect on metabolism and inflammation may help the skin. **You may be eligible if...** - You are 18 years or older - You have plaque psoriasis covering at least 3% of your body and a moderate severity score (PASI ≥3) - Your BMI is 25 or higher (overweight or obese) - You have not used systemic psoriasis medications (like methotrexate) for at least 8 weeks - You have not used biologic psoriasis treatments for at least 3 months **You may NOT be eligible if...** - You have a type of psoriasis other than plaque psoriasis - You have uncontrolled diabetes (HbA1c above 9%) - You have a history of pancreatitis or thyroid cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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).