Effects of Semaglutide on Clinical Outcomes and Metabolic Inflammation in Psoriasis: A Randomized, Triple-Blind, Placebo-Controlled Clinical Trial
New trial tests if a diabetes drug can improve psoriasis and inflammation
Plain English Summary
Effects of Semaglutide on Clinical Outcomes and Metabolic Inflammation in Psoriasis is a Phase 4 clinical trial sponsored by Hospital Universitario Dr. Jose E. Gonzalez studying Psoriasis (PsO), Obesity & Overweight, Diabetes Mellitus - Type 2. This study is testing if an oral diabetes medication, semaglutide, can help improve skin symptoms and reduce inflammation in people with psoriasis. It is for adults with plaque psoriasis who are also overweight or have type 2 diabetes. Participants will take either semaglutide or a placebo (inactive pill) by mouth daily for 12 weeks, along with their usual topical psoriasis treatment. Alternative treatments for psoriasis include topical creams, light therapy, and other oral or injectable medications. The trial aims to enroll 62 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are 18 or older and have been diagnosed with plaque psoriasis that affects at least 3% of your body surface area and scores 3 or higher on a severity scale. You must also be overweight or have a BMI of 25 or higher, and have or not have type 2 diabetes. If you have type 2 diabetes, it must be well-controlled with stable medication for at least 3 months. You cannot join if you have other forms of psoriasis, are pregnant or breastfeeding, have certain types of diabetes, a history of thyroid cancer, or other serious health conditions like heart or liver problems. This trial is studying Psoriasis (PsO), Obesity & Overweight, Diabetes Mellitus - Type 2, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures how the drug affects a specific marker of inflammation related to fat metabolism, indicating if the drug can reduce underlying inflammation in the body. The specific primary outcome measures are: Effect of GLP-1 Receptor Agonists on SCD-1 Activity (Baseline to Week 12). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This is a Phase 4 (post-marketing) study of a treatment that has already received FDA approval. Phase 4 trials monitor long-term safety, effectiveness in broader patient populations, and potential interactions with other treatments in real-world settings. These studies can involve thousands of patients and help identify rare side effects that may not have appeared in earlier, smaller trials.
Why This Trial Matters
This trial matters because it explores a new way to treat psoriasis by targeting inflammation and metabolic health, potentially offering a dual benefit for patients with psoriasis and related conditio This research targets Psoriasis (PsO), Obesity & Overweight, Diabetes Mellitus - Type 2, where improved treatment options are needed.
Investor Insight
This trial investigates semaglutide, a popular diabetes drug, for a new indication (psoriasis), suggesting potential for market expansion if successful, especially given the overlap between psoriasis This treatment is already approved and on the market. This post-marketing study monitors real-world outcomes.
Is This Trial Right for Me?
Ask your doctor if this trial is right for you, especially considering your current psoriasis treatments and overall health. You will need to take a pill daily for 12 weeks and attend regular study visits for assessments. Your skin condition, inflammation markers, and other health indicators will be monitored throughout the study. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: QUADRUPLE
- Enrollment: 62 participants
Interventions
- DRUG: Semaglutide (Rybelsus®) — 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).
- DRUG: Placebo — 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).
Primary Outcomes
- Effect of GLP-1 Receptor Agonists on SCD-1 Activity (Baseline to Week 12)
Secondary Outcomes
- 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)
Full Eligibility Criteria
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.
Trial Locations
- Hospital Universitario Dr. José E. González, Monterrey, N.L., Mexico
Frequently Asked Questions
What is clinical trial NCT07401992?
NCT07401992 is a Phase 4 INTERVENTIONAL study titled "Effects of Semaglutide on Clinical Outcomes and Metabolic Inflammation in Psoriasis." It is currently recruiting and is sponsored by Hospital Universitario Dr. Jose E. Gonzalez. The trial targets enrollment of 62 participants.
What conditions does NCT07401992 study?
This trial investigates treatments for Psoriasis (PsO), Obesity & Overweight, Diabetes Mellitus - Type 2. The primary condition under study is Psoriasis (PsO).
What treatments are being tested in NCT07401992?
The interventions being studied include: Semaglutide (Rybelsus®) (DRUG), Placebo (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).
What does Phase 4 mean for NCT07401992?
Phase 4 trials occur after a treatment is already approved and on the market. They monitor long-term effectiveness and safety in larger populations under real-world conditions.
What is the current status of NCT07401992?
This trial is currently "Recruiting." It started on 2026-01-15. The estimated completion date is 2027-02-28.
Who is sponsoring NCT07401992?
NCT07401992 is sponsored by Hospital Universitario Dr. Jose E. Gonzalez. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07401992?
The trial aims to enroll 62 participants. The trial is currently recruiting and accepting new participants.
How is NCT07401992 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs quadruple masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT07401992?
The primary outcome measures are: Effect of GLP-1 Receptor Agonists on SCD-1 Activity (Baseline to Week 12). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07401992 being conducted?
This trial is being conducted at 1 site, including Monterrey, N.L. (Mexico).
Where can I find official information about NCT07401992?
The official record for NCT07401992 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07401992. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07401992 testing in simple terms?
This study is testing if an oral diabetes medication, semaglutide, can help improve skin symptoms and reduce inflammation in people with psoriasis. It is for adults with plaque psoriasis who are also overweight or have type 2 diabetes.
Why is this trial significant?
This trial matters because it explores a new way to treat psoriasis by targeting inflammation and metabolic health, potentially offering a dual benefit for patients with psoriasis and related conditio
What are the potential risks of participating in NCT07401992?
Common side effects of semaglutide can include nausea, vomiting, diarrhea, and constipation. There is a risk of more serious side effects like pancreatitis or gallbladder problems, though these are less common. The topical treatments used in the trial can cause skin irritation or redness. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07401992?
Ask your doctor if this trial is right for you, especially considering your current psoriasis treatments and overall health. You will need to take a pill daily for 12 weeks and attend regular study visits for assessments. Your skin condition, inflammation markers, and other health indicators will be monitored throughout the study. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07401992 signal from an investment perspective?
This trial investigates semaglutide, a popular diabetes drug, for a new indication (psoriasis), suggesting potential for market expansion if successful, especially given the overlap between psoriasis This is a Phase 4 trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will take either semaglutide or a placebo (inactive pill) by mouth daily for 12 weeks, along with their usual topical psoriasis treatment. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.