NCT07401992RecruitingPhase 4
Effects of Semaglutide on Clinical Outcomes and Metabolic Inflammation in Psoriasis
Effects of Semaglutide on Clinical Outcomes and Metabolic Inflammation in Psoriasis: A Randomized, Triple-Blind, Placebo-Controlled Clinical Trial
Source: ClinicalTrials.gov · Last updated 11 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 62 (estimated)
- First submitted
- 27 Jan 2026
- Start date
- 15 Jan 2026
- Primary completion date
- 28 Feb 2027
- Lead sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- Diseases
- Psoriasis, Obesity, Type 2 diabetes
- NCT number
- NCT07401992
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 62
- From 15 Jan 2026 to the primary completion date, 28 Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario Dr. Jose E. Gonzalez Coordinator of this site? Confirm its status | Monterrey | Mexico | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.