Semaglutide plus topical steroid/calcipotriol for plaque psoriasis in adults with overweight, obesity, or type 2 diabetes
Effects of Semaglutide on Clinical Outcomes and Metabolic Inflammation in Psoriasis: A Randomized, Triple-Blind, Placebo-Controlled Clinical Trial
This trial will test whether taking oral semaglutide along with a topical steroid/calcipotriol cream improves skin symptoms and reduces metabolic inflammation in adults with plaque psoriasis who are overweight, obese, or have type 2 diabetes.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Universitario Dr. Jose E. Gonzalez Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Monterrey, N.L.) |
| Trial ID | NCT07401992 on ClinicalTrials.gov |
What this trial studies
This randomized, triple-blind, placebo-controlled Phase 4 trial will enroll 62 adults with plaque psoriasis and BMI ≥25 kg/m², with or without type 2 diabetes. Participants will be randomized 1:1 to receive oral semaglutide or matching placebo alongside topical corticosteroid/calcipotriol cream for 12 weeks. Clinical efficacy will be measured by Psoriasis Area and Severity Index (PASI) at baseline and weeks 4, 8, and 12, and quality of life will be assessed with DLQI, PROMIS-29, and EQ-5D-5L. Blood-based systemic inflammatory and metabolic markers will be measured to explore changes in metabolic inflammation associated with treatment.
Who should consider this trial
Good fit: Adults (≥18 years) with plaque psoriasis meeting PASI ≥3 and BSA ≥3% who have a BMI ≥25 kg/m², with or without type 2 diabetes (people with diabetes must be on stable therapy and have HbA1c ≤9.0%).
Not a fit: People with non-plaque psoriasis subtypes (for example pustular, guttate, inverse, erythrodermic, nail psoriasis, or psoriatic arthritis), pregnant or breastfeeding individuals, those recently treated with systemic or biologic psoriasis therapies, or insulin-dependent patients are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the treatment could reduce psoriasis severity and improve quality of life while lowering systemic metabolic inflammation, especially for patients with obesity or type 2 diabetes.
How similar studies have performed: Smaller studies and case reports of GLP-1 receptor agonists have suggested skin and metabolic improvements, but randomized controlled data specifically testing semaglutide in psoriasis are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Monterrey, N.L.
- Hospital Universitario Dr. José E. González — Monterrey, N.l., Mexico (Recruiting)
Study contacts
- Study coordinator: Jorge Valdespino, MD
- Email: jorge.valdespino@outlook.com
- Phone: +52 8771093680
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.