Effects of Semaglutide on Clinical Outcomes and Metabolic Inflammation in Psoriasis

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Psoriasis (PsO), Obesity & Overweight, Diabetes Mellitus - Type 2

In brief

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.

Key facts

Study ID

NCT07401992

Run by

Hospital Universitario Dr. Jose E. Gonzalez

People needed

62

Starts

2026-01-15

Expected to finish

2027-02-28

Last updated by the study team

2026-02-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Hospital Universitario Dr. José E. González — Monterrey, N.L., Mexico (enrolling)

Full record on ClinicalTrials.gov

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