Semaglutide plus topical steroid/calcipotriol for plaque psoriasis in adults with overweight, obesity, or type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, triple-blind, placebo-controlled Phase 4 trial will enroll 62 adults with plaque psoriasis and BMI ≥25 kg/m², with or without type 2 diabetes. Participants will be randomized 1:1 to receive oral semaglutide or matching placebo alongside topical corticosteroid/calcipotriol cream for 12 weeks. Clinical efficacy will be measured by Psoriasis Area and Severity Index (PASI) at baseline and weeks 4, 8, and 12, and quality of life will be assessed with DLQI, PROMIS-29, and EQ-5D-5L. Blood-based systemic inflammatory and metabolic markers will be measured to explore changes in metabolic inflammation associated with treatment.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital Universitario Dr. José E. González
  Monterrey, N.l., Mexico Recruiting

Study contacts

• Study coordinator: Jorge Valdespino, MD
• Email: jorge.valdespino@outlook.com
• Phone: +52 8771093680

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• How incretin treatments affect muscle mass and function in people with overweight or obesity

  This study will see how drugs like semaglutide and tirzepatide influence fat-free mass, muscle strength, and physical function in adults with overweight or obesity.

  Recruiting Radboud University Medical Center · Amsterdam and 1 other locations · NCT07929831

• Proliverenol for liver fat and insulin resistance in type 2 diabetes

  This study tests whether adding Proliverenol to standard diabetes care can improve liver fat and blood sugar control in adults with type 2 diabetes.

  Recruiting Phase 2 Universitas Sriwijaya · Palembang, South Sumatera · NCT07928661

• Dose find for remimazolam plus alfentanil for gastroscopy in obese adults

  This trial tests what dose of remimazolam besylate with alfentanil best sedates obese adults during gastroscopy.

  Recruiting Qianfoshan Hospital · Jinan, Shandong · NCT07925684

• Whole-Body Vibration Training in Women With Obesity With and Without Type 2 Diabetes

  This study tests whether eight weeks of supervised whole-body vibration training changes ankle muscle activity and walking performance in women with obesity, comparing those with and without type 2 diabetes.

  Recruiting Pamukkale University · Denizli · NCT07924436

• Two-Year Weight Loss With GLP-1 Medications Compared With Sleeve Gastrectomy in Adults

  This study compares how much weight adults lose over two years when starting GLP-1 medicines versus adults who had sleeve gastrectomy at the same center.

  Recruiting Yuzuncu Yil University · Van · NCT07901777

• Safety test of NNC9836-0001 in adults with overweight/obesity or type 2 diabetes

  This study tests whether the new medicine NNC9836-0001 is safe and tolerable in adults who are overweight or have type 2 diabetes, compared to placebo.

  Recruiting Phase 1 Novo Nordisk A/S · Neuss · NCT07896109

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.