Psoriasis (PsO)Phase 4SEMAPSONCT07401992
Effects of Semaglutide on Clinical Outcomes and Metabolic Inflammation in Psoriasis
A Phase 4 study testing Semaglutide (Rybelsus®) in people with Psoriasis (PsO) and Obesity & Overweight, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis (PsO), Obesity & Overweight, Diabetes Mellitus - Type 2
- What is being tested?
- Semaglutide (Rybelsus®)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteMexico
- Study dates
- 15 Jan 2026to 28 Feb 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Hospital Universitario Dr. José E. González
Monterrey, N.L., 64460
Jorge Valdespino Valdes, MD, +52 8771093680, jorge.valdespino@outlook.com
About this study
Official title: Effects of Semaglutide on Clinical Outcomes and Metabolic Inflammation in Psoriasis: A Randomized, Triple-Blind, Placebo-Controlled Clinical Trial
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.
Read the detailed description
Psoriasis is a chronic inflammatory skin disease frequently associated with metabolic comorbidities, including obesity and type 2 diabetes mellitus. Increasing evidence suggests that systemic metabolic inflammation may contribute to psoriasis severity and treatment response. Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist widely used in the management of type 2 diabetes and obesity, has demonstrated anti-inflammatory effects that may be relevant to psoriasis.
This study is a randomized, triple-blind, placebo-controlled clinical trial designed to evaluate the effects of oral semaglutide on clinical disease activity, quality of life, and metabolic inflammatory markers in patients with plaque psoriasis and overweight/obesity and/or type 2 diabetes mellitus.
A total of 62 participants will be enrolled and randomized in a 1:1 ratio to one of two treatment groups. One group will receive oral semaglutide in combination with topical corticosteroid/calcipotriol cream, while the comparator group will receive oral placebo in combination with topical corticosteroid/calcipotriol cream. All participants will receive treatment for 12 weeks.
Clinical assessments will be performed at baseline and at weeks 4, 8, and 12. Disease severity and clinical response will be evaluated using the Psoriasis Area and Severity Index (PASI) at each visit. Patient-reported quality of life will be assessed using the Dermatology Life Quality Index (DLQI), the Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29), and the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) at baseline and at week 12.
Blood samples will be collected at baseline and at week 12 to evaluate systemic inflammatory and metabolic biomarkers, allowing assessment of changes in metabolic inflammation associated with treatment.
The primary hypothesis is that participants receiving semaglutide in combination with topical corticosteroid/calcipotriol will demonstrate greater improvement in clinical severity and inflammatory markers compared with those receiving placebo plus topical corticosteroid/calcipotriol. Findings from this study may provide evidence supporting the role of metabolic-targeted therapies as adjunctive treatment in psoriasis patients with metabolic comorbidities.
- Being tested
- Semaglutide (Rybelsus®), Placebo
- Keywords
- clinical trial, psoriasis, dermatology, semaglutide, GLP-1, obesity, overweight, diabetes
- Medical subject headings
- Psoriasis, Obesity, Overweight, Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
PlaceboDrug
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 group | Role | What they receive |
|---|---|---|
| Semaglutide group | Active comparator | A total of 31 participants will be randomly assigned to the semaglutide intervention group. Receives: Drug: Semaglutide (Rybelsus®) |
| Placebo group | Placebo comparator | A total of 31 participants will be randomly assigned to the placebo intervention group. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 12
Secondary outcomes (55)
Proportion of Participants Achieving Psoriasis Area and Severity Index (PASI) 75
The proportion of participants achieving a 75% reduction from baseline in the Psoriasis Area and Severity Index (PASI 75) will be compared between the semaglutide and placebo groups.
The Psoriasis Area and Severity Index (PASI) is a validated clinical severity score that ranges from 0 to 72, with higher scores indicating more severe psoriasis. Achievement of PASI 75 represents a clinically meaningful improvement in disease severity.
Measured: Weeks 4, 8, and 12
Change in Body Weight
Change in body weight (kilograms) from baseline to Week 12 will be compared between the semaglutide and placebo groups.
Measured: Baseline and Week 12
Change in Fasting Plasma Glucose
Change in fasting plasma glucose (mg/dL) from baseline to Week 12 will be compared between the semaglutide and placebo groups.
Measured: Baseline and Week 12
Change in Total Cholesterol
Change in serum total cholesterol (mg/dL) from baseline to Week 12 will be compared between the semaglutide and placebo groups.
Measured: Baseline and Week 12
Correlation Between Metabolic Parameters and PASI Improvement
Correlations between PASI improvement and glycemic control (fasting plasma glucose, HbA1c), lipid profile, and anthropometric and hemodynamic parameters (body weight, BMI, waist circumference, hip circumference, waist-to-hip ratio, and blood pressure) will be evaluated overall and by treatment group.
Measured: Baseline to Week 12
Change in Dermatology Life Quality Index (DLQI)
Change from baseline to Week 12 in the Dermatology Life Quality Index (DLQI) score will be compared between the semaglutide and placebo groups.
The Dermatology Life Quality Index (DLQI) is a validated dermatology-specific quality-of-life questionnaire consisting of 10 items, with total scores ranging from 0 to 30, where higher scores indicate greater impairment in quality of life.
Measured: Baseline and Week 12
Correlation Between Psoriasis Severity and Quality of Life Measures
The correlation between psoriasis severity, measured by the Psoriasis Area and Severity Index (PASI), and quality of life, measured by the Dermatology Life Quality Index (DLQI), Patient-Reported Outcomes Measurement Information System 29-Item Profile (PROMIS-29), and EuroQol 5-Dimensions 5-Levels (EQ-5D-5L), will be assessed overall and by treatment group from baseline to Week 12.
PASI ranges from 0 to 72, with higher scores indicating more severe psoriasis. DLQI ranges from 0 to 30, with higher scores indicating greater quality-of-life impairment. PROMIS-29 domain scores are reported as T-scores (mean 50, SD 10); higher scores indicate worse symptoms for most domains, except physical function and social roles, where higher scores indicate better functioning. EQ-5D-5L index scores typically range from less than 0 to 1.0, with higher scores indicating better health-related quality of life.
Measured: Baseline to Week 12
Change in Serum Interleukin-6 (IL-6)
Change in serum interleukin-6 (IL-6) levels from baseline to Week 12 will be compared between the semaglutide and placebo groups.
Measured: Baseline and Week 12
Correlation Between PASI and Inflammatory Biomarkers
Correlations between PASI scores and serum levels of IL-6, IL-17, IL-23, TNF-α, CRP, and ESR will be evaluated overall and by treatment group.
Measured: Baseline to Week 12
PASI Response by Type 2 Diabetes Status
Improvement in PASI scores and the proportion of participants achieving PASI 75 and PASI 90 will be compared between participants with and without type 2 diabetes mellitus, stratified by treatment group.
Measured: Baseline to Week 12
Change in Body Weight in Participants with Type 2 Diabetes
Change in body weight (kg) from baseline to Week 12 in participants with type 2 diabetes mellitus.
Measured: Baseline and Week 12
Change in Serum IL-6 by Diabetes Status
Change in serum interleukin-6 (IL-6) levels from baseline to Week 12 will be compared between participants with and without type 2 diabetes mellitus to evaluate differences in semaglutide-induced inflammatory modulation.
Measured: Baseline and Week 12
Correlation Between Baseline Glycemic Control and Change in Psoriasis Severity
The correlation between baseline glycemic control, measured by fasting plasma glucose (mg/dL) and glycated hemoglobin (HbA1c, %), and change in psoriasis severity, measured by the Psoriasis Area and Severity Index (PASI), will be assessed overall and by treatment group from baseline to Week 12.
The Psoriasis Area and Severity Index (PASI) ranges from 0 to 72, with higher scores indicating more severe psoriasis.
Measured: Baseline to Week 12
Incidence and Type of Adverse Events
Incidence, type, and severity of adverse events associated with semaglutide, reported as number (%) of participants, up to Week 12.
Measured: Up to Week 12
Change in Body Mass Index (BMI)
Change in body mass index (BMI, kg/m²) from baseline to Week 12 will be compared between the semaglutide and placebo groups.
Measured: Baseline and week 12
Change in Waist Circumference
Change in waist circumference (centimeters) from baseline to Week 12 will be compared between the semaglutide and placebo groups.
Measured: Baseline and Week 12
Change in Hip Circumference
Change in hip circumference (centimeters) from baseline to Week 12 will be compared between the semaglutide and placebo groups.
Measured: Baseline and Week 12
Change in Waist-to-Hip Ratio
Change in waist-to-hip ratio from baseline to Week 12 will be compared between the semaglutide and placebo groups.
Measured: Baseline and Week 12
Change in Blood Pressure
Change in systolic and diastolic blood pressure (mmHg) from baseline to Week 12 will be compared between the semaglutide and placebo groups.
Measured: Baseline and Week 12
Time to First Achievement of PASI 75
Time to first achievement of a 75% reduction from baseline in the Psoriasis Area and Severity Index (PASI 75) will be compared between the semaglutide and placebo groups.
The Psoriasis Area and Severity Index (PASI) ranges from 0 to 72, with higher scores indicating more severe psoriasis. Shorter time to PASI 75 represents a better clinical outcome.
Measured: Up to Week 12
Change in PROMIS-29 Profile Score
Change from baseline to Week 12 in Patient-Reported Outcomes Measurement Information System 29-Item Profile (PROMIS-29) scores will be compared between the semaglutide and placebo groups.
PROMIS-29 is a validated patient-reported outcome instrument that assesses multiple health domains. Domain scores are reported as T-scores standardized to a mean of 50 and a standard deviation of 10. For most domains, higher scores indicate worse symptoms or greater impairment, except for physical function and social roles, where higher scores indicate better functioning.
Measured: Baseline and Week 12
Change in EQ-5D-5L Index Score
Change from baseline to Week 12 in the EuroQol 5-Dimensions 5-Levels (EQ-5D-5L) index score will be compared between the semaglutide and placebo groups.
The EQ-5D-5L is a standardized instrument for measuring health-related quality of life. Index scores typically range from less than 0 (health states worse than death) to 1.0, where higher scores indicate better health status.
Measured: Baseline and Week 12
Change in Serum Interleukin-17 (IL-17)
Change in serum interleukin-17 (IL-17) levels from baseline to Week 12 will be compared between the semaglutide and placebo groups.
Measured: Baseline and Week 12
Change in Serum Interleukin-23 (IL-23)
Change in serum interleukin-23 (IL-23) levels from baseline to Week 12 will be compared between the semaglutide and placebo groups.
Measured: Baseline and Week 12
Change in Serum Tumor Necrosis Factor-Alpha (TNF-α)
Change in serum tumor necrosis factor-alpha (TNF-α) levels from baseline to Week 12 will be compared between the semaglutide and placebo groups.
Measured: Baseline and Week 12
Change in Serum C-Reactive Protein (CRP)
Change in serum C-reactive protein (CRP) levels from baseline to Week 12 will be compared between the semaglutide and placebo groups.
Measured: Baseline and Week 12
Change in Erythrocyte Sedimentation Rate (ESR)
Change in erythrocyte sedimentation rate (ESR) from baseline to Week 12 will be compared between the semaglutide and placebo groups.
Measured: Baseline and Week 12
Correlation Between Baseline Glycemic Control and Change in Metabolic Parameters
The correlation between baseline glycemic control, measured by fasting plasma glucose (mg/dL) and glycated hemoglobin (HbA1c, %), and changes in metabolic parameters, including body weight (kg), body mass index (kg/m²), and serum acylcarnitine profile, will be assessed overall and by treatment group from baseline to Week 12.
Measured: Baseline to Week 12
Change in Body Mass Index (BMI) by Diabetes Status
Change in body mass index (BMI, kg/m²) from baseline to Week 12 will be compared between participants with and without type 2 diabetes mellitus.
Measured: Baseline and Week 12
Change in Acylcarnitine Profile by Diabetes Status
Change in serum acylcarnitine profile from baseline to Week 12 will be compared between participants with and without type 2 diabetes mellitus.
Measured: Baseline and Week 12
Change in Serum IL-17 by Diabetes Status
Change in serum interleukin-17 (IL-17) levels from baseline to Week 12 will be compared between participants with and without type 2 diabetes mellitus.
Measured: Baseline and Week 12
Change in Serum IL-23 by Diabetes Status
Change in serum interleukin-23 (IL-23) levels from baseline to Week 12 will be compared between participants with and without type 2 diabetes mellitus.
Measured: Baseline and Week 12
Change in Serum TNF-α by Diabetes Status
Change in serum tumor necrosis factor-alpha (TNF-α) levels from baseline to Week 12 will be compared between participants with and without type 2 diabetes mellitus.
Measured: Baseline and Week 12
Change in Serum CRP by Diabetes Status
Change in serum C-reactive protein (CRP) levels from baseline to Week 12 will be compared between participants with and without type 2 diabetes mellitus.
Measured: Baseline and Week 12
Change in ESR by Diabetes Status
Change in erythrocyte sedimentation rate (ESR) from baseline to Week 12 will be compared between participants with and without type 2 diabetes mellitus.
Measured: Baseline and Week 12
Change in HbA1c
Change in glycated hemoglobin (HbA1c, %) from baseline to Week 12.
Measured: Baseline to Week 12
Change in HDL Cholesterol
Change in HDL cholesterol (mg/dL) from baseline to Week 12 will be compared between the semaglutide and placebo groups.
Measured: Baseline to Week 12
Change in LDL Cholesterol
Change in LDL cholesterol (mg/dL) from baseline to Week 12 will be compared between the semaglutide and placebo groups.
Measured: Baseline to Week 12
Change in VLDL Cholesterol
Change in VLDL cholesterol (mg/dL) from baseline to Week 12 will be compared between the semaglutide and placebo groups.
Measured: Baseline to Week 12
Change in Triglycerides
Change in triglycerides (mg/dL) from baseline to Week 12 will be compared between the semaglutide and placebo groups.
Measured: Baseline to Week 12
Change in Body Weight in Participants without Type 2 Diabetes
Change in body weight (kg) from baseline to Week 12 in participants without type 2 diabetes mellitus.
Measured: Baseline to Week 12
Change in Body Mass Index (BMI) in Participants with Type 2 Diabetes
Change in BMI (kg/m²) from baseline to Week 12 in participants with type 2 diabetes mellitus.
Measured: Baseline to Week 12
Change in Body Mass Index (BMI) in Participants without Type 2 Diabetes
Change in BMI (kg/m²) from baseline to Week 12 in participants without type 2 diabetes mellitus.
Measured: Baseline to Week 12
Change in Serum IL-6 in Participants with Type 2 Diabetes
Change in serum interleukin-6 (IL-6, pg/mL) from baseline to Week 12 in participants with type 2 diabetes mellitus.
Measured: Baseline to Week 12
Change in Serum IL-6 in Participants without Type 2 Diabetes
Change in serum interleukin-6 (IL-6, pg/mL) from baseline to Week 12 in participants without type 2 diabetes mellitus.
Measured: Baseline to Week 12
Change in Serum IL-17 in Participants without Type 2 Diabetes
Change in serum interleukin-17 (IL-17, pg/mL) from baseline to Week 12 in participants without type 2 diabetes mellitus.
Measured: Baseline to Week 12
Change in Serum IL-17 in Participants with Type 2 Diabetes
Change in serum interleukin-17 (IL-17, pg/mL) from baseline to Week 12 in participants with type 2 diabetes mellitus.
Measured: Baseline to Week 12
Change in Serum IL-23 in Participants with Type 2 Diabetes
Change in serum interleukin-23 (IL-23, pg/mL) from baseline to Week 12 in participants with type 2 diabetes mellitus.
Measured: Baseline to Week 12
Change in Serum IL-23 in Participants without Type 2 Diabetes
Change in serum interleukin-23 (IL-23, pg/mL) from baseline to Week 12 in participants without type 2 diabetes mellitus.
Measured: Baseline to Week 12
Change in Serum TNF-α in Participants with Type 2 Diabetes
Change in serum tumor necrosis factor-alpha (TNF-α, pg/mL) from baseline to Week 12 in participants with type 2 diabetes mellitus.
Measured: Baseline to Week 12
Change in Serum TNF-α in Participants without Type 2 Diabetes
Change in serum tumor necrosis factor-alpha (TNF-α, pg/mL) from baseline to Week 12 in participants without type 2 diabetes mellitus.
Measured: Baseline to Week 12
Change in Serum C-Reactive Protein (CRP) in Participants with Type 2 Diabetes
Change in serum C-reactive protein (CRP, mg/L) from baseline to Week 12 in participants with type 2 diabetes mellitus.
Measured: Baseline to Week 12
Change in Serum C-Reactive Protein (CRP) in Participants without Type 2 Diabetes
Change in serum C-reactive protein (CRP, mg/L) from baseline to Week 12 in participants without type 2 diabetes mellitus.
Measured: Baseline to Week 12
Change in Erythrocyte Sedimentation Rate (ESR) in Participants with Type 2 Diabetes
Change in erythrocyte sedimentation rate (ESR, mm/h) from baseline to Week 12 in participants with type 2 diabetes mellitus.
Measured: Baseline to Week 12
Change in Erythrocyte Sedimentation Rate (ESR) in Participants without Type 2 Diabetes
Change in erythrocyte sedimentation rate (ESR, mm/h) from baseline to Week 12 in participants without type 2 diabetes mellitus.
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start15 Jan 2026
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis (PsO)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jorge Valdespino Valdes, Hospital Universitario Dr. Jose E. Gonzalez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07401992
- Sponsor's protocol ID
- DE26-00001
- Acronym
- SEMAPSO
- Status last verified
- Feb 2026
- First submitted
- 27 Jan 2026
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Semaglutide on Clinical Outcomes and Metabolic Inflammation in Psoriasis: A Randomized, Triple-Blind, Placebo-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07401992
- Acronym / sponsor ID
- SEMAPSO / DE26-00001
- Keywords
- clinical trial, psoriasis, dermatology, semaglutide, GLP-1, obesity, overweight, diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Hospital Universitario Dr. Jose E. GonzalezUniversity, hospital or other
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Psoriasis is a chronic inflammatory skin disease frequently associated with metabolic comorbidities, including obesity and type 2 diabetes mellitus. Increasing evidence suggests that systemic metabolic inflammation may contribute to psoriasis severity and treatment response. Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist widely used in the management of type 2 diabetes and obesity, has demonstrated anti-inflammatory effects that may be relevant to psoriasis.
This study is a randomized, triple-blind, placebo-controlled clinical trial designed to evaluate the effects of oral semaglutide on clinical disease activity, quality of life, and metabolic inflammatory markers in patients with plaque psoriasis and overweight/obesity and/or type 2 diabetes mellitus.
A total of 62 participants will be enrolled and randomized in a 1:1 ratio to one of two treatment groups. One group will receive oral semaglutide in combination with topical corticosteroid/calcipotriol cream, while the comparator group will receive oral placebo in combination with topical corticosteroid/calcipotriol cream. All participants will receive treatment for 12 weeks.
Clinical assessments will be performed at baseline and at weeks 4, 8, and 12. Disease severity and clinical response will be evaluated using the Psoriasis Area and Severity Index (PASI) at each visit. Patient-reported quality of life will be assessed using the Dermatology Life Quality Index (DLQI), the Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29), and the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) at baseline and at week 12.
Blood samples will be collected at baseline and at week 12 to evaluate systemic inflammatory and metabolic biomarkers, allowing assessment of changes in metabolic inflammation associated with treatment.
The primary hypothesis is that participants receiving semaglutide in combination with topical corticosteroid/calcipotriol will demonstrate greater improvement in clinical severity and inflammatory markers compared with those receiving placebo plus topical corticosteroid/calcipotriol. Findings from this study may provide evidence supporting the role of metabolic-targeted therapies as adjunctive treatment in psoriasis patients with metabolic comorbidities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semaglutide group | Active comparator | Drug: Semaglutide (Rybelsus®)A total of 31 participants will be randomly assigned to the semaglutide intervention group. |
| Placebo group | Placebo comparator | Drug: PlaceboA total of 31 participants will be randomly assigned to the placebo intervention group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Semaglutide group |
| PlaceboA 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). | Drug | Placebo group |
Primary outcome
Effect of GLP-1 Receptor Agonists on SCD-1 Activity
Time frame: Baseline to Week 12
Change in SCD-1 activity, assessed via acylcarnitine profile (µmol/L), from baseline to Week 12.
55 secondary outcomes
Proportion of Participants Achieving Psoriasis Area and Severity Index (PASI) 75
Time frame: Weeks 4, 8, and 12
Change in Body Weight
Time frame: Baseline and Week 12
Change in Fasting Plasma Glucose
Time frame: Baseline and Week 12
Change in Total Cholesterol
Time frame: Baseline and Week 12
Correlation Between Metabolic Parameters and PASI Improvement
Time frame: Baseline to Week 12
Change in Dermatology Life Quality Index (DLQI)
Time frame: Baseline and Week 12
Correlation Between Psoriasis Severity and Quality of Life Measures
Time frame: Baseline to Week 12
Change in Serum Interleukin-6 (IL-6)
Time frame: Baseline and Week 12
Correlation Between PASI and Inflammatory Biomarkers
Time frame: Baseline to Week 12
PASI Response by Type 2 Diabetes Status
Time frame: Baseline to Week 12
Change in Body Weight in Participants with Type 2 Diabetes
Time frame: Baseline and Week 12
Change in Serum IL-6 by Diabetes Status
Time frame: Baseline and Week 12
Correlation Between Baseline Glycemic Control and Change in Psoriasis Severity
Time frame: Baseline to Week 12
Incidence and Type of Adverse Events
Time frame: Up to Week 12
Change in Body Mass Index (BMI)
Time frame: Baseline and week 12
Change in Waist Circumference
Time frame: Baseline and Week 12
Change in Hip Circumference
Time frame: Baseline and Week 12
Change in Waist-to-Hip Ratio
Time frame: Baseline and Week 12
Change in Blood Pressure
Time frame: Baseline and Week 12
Time to First Achievement of PASI 75
Time frame: Up to Week 12
Change in PROMIS-29 Profile Score
Time frame: Baseline and Week 12
Change in EQ-5D-5L Index Score
Time frame: Baseline and Week 12
Change in Serum Interleukin-17 (IL-17)
Time frame: Baseline and Week 12
Change in Serum Interleukin-23 (IL-23)
Time frame: Baseline and Week 12
Change in Serum Tumor Necrosis Factor-Alpha (TNF-α)
Time frame: Baseline and Week 12
Change in Serum C-Reactive Protein (CRP)
Time frame: Baseline and Week 12
Change in Erythrocyte Sedimentation Rate (ESR)
Time frame: Baseline and Week 12
Correlation Between Baseline Glycemic Control and Change in Metabolic Parameters
Time frame: Baseline to Week 12
Change in Body Mass Index (BMI) by Diabetes Status
Time frame: Baseline and Week 12
Change in Acylcarnitine Profile by Diabetes Status
Time frame: Baseline and Week 12
Change in Serum IL-17 by Diabetes Status
Time frame: Baseline and Week 12
Change in Serum IL-23 by Diabetes Status
Time frame: Baseline and Week 12
Change in Serum TNF-α by Diabetes Status
Time frame: Baseline and Week 12
Change in Serum CRP by Diabetes Status
Time frame: Baseline and Week 12
Change in ESR by Diabetes Status
Time frame: Baseline and Week 12
Change in HbA1c
Time frame: Baseline to Week 12
Change in HDL Cholesterol
Time frame: Baseline to Week 12
Change in LDL Cholesterol
Time frame: Baseline to Week 12
Change in VLDL Cholesterol
Time frame: Baseline to Week 12
Change in Triglycerides
Time frame: Baseline to Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Individual participant dataSharing planned: Yes. Upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Semaglutide (Rybelsus®) in people with Psoriasis (PsO) and Obesity & Overweight, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jorge Valdespino, MD (+52 8771093680, jorge.valdespino@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of GLP-1 Receptor Agonists on SCD-1 Activity (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.