Actively Recruiting
Effects of Semaglutide on Clinical Outcomes and Metabolic Inflammation in Psoriasis
Led by Hospital Universitario Dr. Jose E. Gonzalez · Updated on 2026-02-11
62
Participants Needed
1
Research Sites
58 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effects of Semaglutide on Clinical Outcomes and Metabolic Inflammation in Psoriasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 6518 years at the time of randomization
- Clinical diagnosis of plaque psoriasis with Psoriasis Area and Severity Index (PASI) 653 and body surface area (BSA) 653%
- Body mass index (BMI) 6525 kg/m�b2, 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 659.0% 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hospital Universitario Dr. José E. González
Monterrey, N.L., Mexico, 64460
Actively Recruiting
Research Team
J
Jorge Valdespino, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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