Effects of Semaglutide on Clinical Outcomes and Metabolic Inflammation in Psoriasis
- Status
- RecruitingResults none
- Why it is watched
- non-weight indication: inflammation, rheumatologic
- Who it enrolls
- age 18 Years to no upper limit; excludes diabetes; BMI ≥25 required; conditions: Psoriasis (PsO); Obesity & Overweight; Diabetes Mellitus - Type 2
- Interventions
- Semaglutide (Rybelsus®); Placebo
- Conditions
- Psoriasis (PsO); Obesity & Overweight; Diabetes Mellitus - Type 2
- Phase and size
- Phase 4 · 62 participants
- Dates
- Start 2026-01-15
Primary completion 2027-02-28 - Sponsor
- Hospital Universitario Dr. Jose E. Gonzalez (Other)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- Effect of GLP-1 Receptor Agonists on SCD-1 ActivityBaseline to Week 12
02Eligibility
Who can take part
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.
03Change log
Registry changes
No changes recorded since the trial was added.