Actively Recruiting
Effects of Semaglutide on Clinical Outcomes and Metabolic Inflammation in Psoriasis: A Randomized, Triple-Blind, Placebo-Controlled Clinical Trial
Led by Hospital Universitario Dr. Jose E. Gonzalez · Updated on 2026-02-11
62
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of oral semaglutide combined with topical corticosteroid and calcipotriol cream on clinical outcomes and metabolic inflammation in adults with plaque psoriasis who are overweight, obese, and/or have type 2 diabetes. This randomized, triple-blind, placebo-controlled trial aims to study how semaglutide impacts psoriasis severity, quality of life, and systemic inflammatory markers compared to placebo. The study involves 62 participants with metabolic comorbidities linked to psoriasis severity and treatment response. Participants will be randomly assigned to receive either oral semaglutide or a placebo daily for 12 weeks. Semaglutide dosing starts at 3 mg daily for 4 weeks, then increases to 7 mg daily for 4 weeks, and finally 14 mg daily for the last 4 weeks. All participants will apply a topical corticosteroid and vitamin D analog (calcipotriol) cream during the treatment period. The trial includes two groups: one receiving semaglutide plus topical therapy, and the other receiving placebo plus topical therapy. During the study, participants will undergo clinical assessments at baseline and weeks 4, 8, and 12. Psoriasis severity will be measured using the Psoriasis Area and Severity Index (PASI), and quality of life will be assessed with the Dermatology Life Quality Index (DLQI), PROMIS-29, and EQ-5D-5L questionnaires. Blood samples will be collected at baseline and week 12 to analyze metabolic and inflammatory biomarkers. The primary outcome is the effect on SCD-1 activity, with multiple secondary outcomes including changes in weight, glucose, cholesterol, inflammatory markers, and quality of life scores. Safety and adverse events will also be monitored throughout the 12-week treatment period.
CONDITIONS
Brief 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 18 years or older at the time of randomization.
- Clinical diagnosis of plaque psoriasis with Psoriasis Area and Severity Index (PASI) of 3 or higher and body surface area (BSA) of 3% or more.
- Body mass index (BMI) of 25 kg/m² or higher, indicating overweight or obesity.
- Participants with or without type 2 diabetes mellitus.
- Participants with diabetes must be on stable antidiabetic therapy with no medication or dosage changes in the previous 3 months and have HbA1c of 9.0% or less at baseline.
- No use of systemic psoriasis therapies 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 non-plaque psoriasis subtypes including pustular, guttate, nail, inverse, psoriatic arthritis, or erythrodermic psoriasis.
- Pregnancy or breastfeeding at screening or enrollment.
- Insulin-dependent diabetes mellitus or current use of sulfonylureas.
- Active malignancy at 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
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive either oral semaglutide or placebo daily in combination with a topical corticosteroid and vitamin D analog cream for psoriasis management. Treatment includes dose escalation of the oral medication over 12 weeks.
4 visits (baseline, Week 4, Week 8, and Week 12)
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
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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