Effects of Semaglutide on Clinical Outcomes and Metabolic Inflammation in Psoriasis

Sponsor
Hospital Universitario Dr. Jose E. Gonzalez
Study ID
NCT07401992
Phase
PHASE4
Status
Recruiting
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Conditions

  • Diabetes Mellitus - Type 2
  • Obesity & Overweight
  • Psoriasis (PsO)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Semaglutide (Rybelsus®) — DRUG
    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).
  • Placebo — DRUG
    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).

Study Details

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.

Key Dates

Start date
Jan 15, 2026
Status verified
Feb 2026
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
62 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Semaglutide group
    A total of 31 participants will be randomly assigned to the semaglutide intervention group.
  • Placebo Comparator: Placebo group
    A total of 31 participants will be randomly assigned to the placebo intervention group.

Primary Outcome Measure

Effect of GLP-1 Receptor Agonists on SCD-1 Activity [ Time Frame: Baseline to Week 12 ]

Central Contacts

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