Trial intelligence / Profile preview

Semaglutide for Psoriasis in T2DM

NCT06475586Phase 4

Key facts

Status
Completed
Start
May 2023
Primary completion
Mar 2024
Countries
1
Sponsor
University of Banja Luka
Modality
Peptides, Recombinant Proteins and Enzymes
Conditions
psoriasistype 2 diabetes mellitus (T2DM)
01

Overview

Phase 4, randomised, open-label trial of semaglutide in psoriasis and type 2 diabetes mellitus (T2DM) (2 arms), sponsored by University of Banja Luka. Primary endpoints: Psoriasis Area and Severity Index at 12 weeks, Body Mass Index at 12 weeks and 7 more. Started May 2023; status: completed.

02

Design

2 arms
Study design
RandomizedOpen-label
  • Semaglutide Arm

    Semaglutide added to Metformin

  • Control Arm

    Standard of Care (Metformin)

03

Who it enrols

Patients with type 2 diabetes mellitus (diagnosed >6 months) and moderate-to-severe plaque psoriasis (PASI >= 10) on maximally tolerated metformin. Excludes patients on other GLP-1 RAs, SGLT-2 inhibitors, or recent systemic psoriasis therapy.

04

Endpoints

Primary

  • Psoriasis Area and Severity Index

  • Body Mass Index

  • Serum values of TNFa, IL-1b, IL-6, IL-17 and IL-23

  • Hemoglobin A1c

  • Lipid Status

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