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New treatment option for Psoriasis (PsO)
Official title Effects of Semaglutide on Clinical Outcomes and Metabolic Inflammation in Psoriasis
ClinicalTrials.gov ID: NCT07401992
What this study is testing
What is Semaglutide (Rybelsus®)?
Semaglutide (Rybelsus®) is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for psoriasis (pso).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
You likely can't join 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Monterrey, N.L., Mexico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Monterrey, N.L., Mexico. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.