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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with plaque psoriasis who are also overweight or obese, with or without type 2 diabetes. It tests oral semaglutide plus a topical cream against placebo plus the cream for 12 weeks.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Plaque psoriasis with PASI ≥3 and body surface area (BSA) ≥3%. BMI ≥25 kg/m². People with diabetes need HbA1c ≤9.0% (75 mmol/mol) at baseline.
- Earlier treatment
- No systemic psoriasis treatment (for example methotrexate, cyclosporine) for at least 8 weeks. No biologic treatment for at least 3 months. People with diabetes must be on stable diabetes treatment, with no change in medicine or dose in the previous 3 months.
Main reasons for not taking part
- Other psoriasis types (pustular, guttate, nail, inverse, psoriatic arthritis, erythrodermic)
- Pregnancy or breastfeeding
- Insulin-dependent diabetes or current use of sulfonylureas
- Current treatment with other GLP-1 receptor agonists
- History of pancreatitis, thyroid tumour or inflammatory bowel disease
Read by machine on 9 November 2026.
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.