Oral semaglutide for plaque psoriasis in people with overweight, obesity or type 2 diabetes
Tests semaglutide tablets in adults with psoriasis and overweight, obesity or diabetes.
Plain-language title generated from the registry record
Registry title: Effects of Semaglutide on Clinical Outcomes and Metabolic Inflammation in Psoriasis
Key facts
- Where
- Monterrey, MexicoSee the site
- Phase
- Phase 4
Where in Mexico
- Hospital Universitario Dr. Jose E. GonzalezMonterrey, MexicoTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hospital Universitario Dr. Jose E. Gonzalez
- Trial code
- NCT07401992
- Record updated
- 11 February 2026
- Original description
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.Read full original descriptionShow less
Effects of Semaglutide on Clinical Outcomes and Metabolic Inflammation in Psoriasis: A Randomized, Triple-Blind, Placebo-Controlled Clinical Trial
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.
Inclusion: 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.
Exclusion: Use of systemic therapies within 8 weeks prior to randomization; Use of biologic therapies within 3 months prior to randomization; Current treatment with other GLP-1 receptor agonists; Insulin-dependent diabetes mellitus or current use of sulfonylureas; Active malignancy at the time of screening; History of thyroid neoplasia; Presence of autoimmune diseases; Renal insufficiency; Heart failure; Hepatic insufficiency; History of pancreatitis; History of inflammatory bowel disease; Known allergy to starch; 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.