Effects of Semaglutide on Clinical Outcomes and Metabolic Inflammation in Psoriasis
Eligible age
18+ yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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About this study
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.
Sponsor: Hospital Universitario Dr. Jose E. Gonzalez
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.
Source: ClinicalTrials.gov · NCT07401992 · last updated 2026-02-11