Effects of Semaglutide on Clinical Outcomes and Metabolic Inflammation in Psoriasis

What Was Tested

The trial (phase 4) is built around Semaglutide for psoriasis and psoriatic arthritis.

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.

It had two arms (groups): Semaglutide group (active comparator) and Placebo group (placebo comparator).

A total of 31 participants will be randomly assigned to the semaglutide intervention group.

A total of 31 participants will be randomly assigned to the placebo intervention group.

The registry classes the interventions as drug.

More on the Plan

This study is a randomized, triple-blind, placebo-controlled clinical trial designed to evaluate the effects of oral semaglutide on clinical disease activity, quality of life, and metabolic inflammatory markers in patients with plaque psoriasis and overweight/obesity and/or type 2 diabetes mellitus.

A total of 62 participants will be enrolled and randomized in a 1:1 ratio to one of two treatment groups.

One group will receive oral semaglutide in combination with topical corticosteroid/calcipotriol cream, while the comparator group will receive oral placebo in combination with topical corticosteroid/calcipotriol cream.

All participants will receive treatment for 12 weeks.

Who Took Part

62 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male or female participants aged ≥18 years at the time of randomization. Body mass index (BMI) ≥25 kg/m², consistent with overweight or obesity. Participants with or without type 2 diabetes mellitus. 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.

The full record lists 7 inclusion and 15 exclusion criteria; among the exclusions: 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.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.

Groups ran in parallel: each of the psoriasis and psoriatic arthritis participants stayed in one arm throughout.

Neither the psoriasis and psoriatic arthritis participants nor the staff measuring them knew who was on Semaglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2026-01-15 with completion listed for 2027-02-28.

It ran at 1 site in Mexico.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Effect of GLP-1 Receptor Agonists on SCD-1 Activity (time frame: Baseline to Week 12).

It also tracked 55 secondary outcomes, for example Proportion of Participants Achieving Psoriasis Area and Severity Index (PASI) 75, Change in Body Weight, Change in Fasting Plasma Glucose, Change in Total Cholesterol, Change in Dermatology Life Quality Index (DLQI) and Correlation Between Psoriasis Severity and Quality of Life Measures.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Semaglutide in 62 people with psoriasis and psoriatic arthritis.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, Psoriasis and psoriatic arthritis research.