Effects of Semaglutide on Clinical Outcomes and Metabolic Inflammation in Psoriasis

NCT07401992 | Recruiting Phase 4 DMC

• 1 other identifier: DE26-00001
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

clinical trial; psoriasis; dermatology; semaglutide; GLP-1; obesity; overweight; diabetes

Outcome Measures

Primary Outcomes (1)

• Effect of GLP-1 Receptor Agonists on SCD-1 Activity

  Change in SCD-1 activity, assessed via acylcarnitine profile (µmol/L), from baseline to Week 12.

  Baseline to Week 12

Secondary Outcomes (55)

• Proportion of Participants Achieving Psoriasis Area and Severity Index (PASI) 75

  Weeks 4, 8, and 12

• Change in Body Weight

  Baseline and Week 12

• Change in Fasting Plasma Glucose

  Baseline and Week 12

• Change in Total Cholesterol

  Baseline and Week 12

• Correlation Between Metabolic Parameters and PASI Improvement

  Baseline to Week 12

Study Arms (2)

Semaglutide group

ACTIVE COMPARATOR

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

Drug: Semaglutide (Rybelsus®)

Placebo group

PLACEBO COMPARATOR

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

Drug: Placebo

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).

Semaglutide group

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).

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario Dr. Jose E. Gonzalez: lead

Study Sites (1)

Hospital Universitario Dr. José E. González

Monterrey, N.L., 64460, Mexico

RECRUITING

MeSH Terms

Conditions

Psoriasis; Obesity; Overweight; Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Jorge Valdespino, MD

CONTACT

+52 8771093680; jorge.valdespino@outlook.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 11, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

ME (1)