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RECRUITINGPhase 4INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This 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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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 conditions (where your immune system attacks your own body)s. - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Semaglutide (Rybelsus®)

Oral semaglutide will be administered once daily at a dose of 3 mg for the first 4 weeks, followed by 7 mg once daily for the next 4 weeks, and 14 mg once daily for the final 4 weeks (total treatment duration: 12 weeks). All participants will also receive conventional topical therapy for 12 weeks, consisting of a topical corticosteroid and a vitamin D analog (calcipotriol).

DRUG

Placebo

A total of 31 participants will be randomly assigned to the placebo intervention group. They will receive a daily placebo tablet containing starch for 12 weeks. All participants will also receive conventional topical therapy for 12 weeks, consisting of a topical corticosteroid and a vitamin D analog (calcipotriol).

Locations (1)

Hospital Universitario Dr. José E. González
Monterrey, N.L., Mexico