A Phase 4 interventional study of Semaglutide (Rybelsus®) and Placebo in Psoriasis (PsO), Obesity & Overweight and Diabetes Mellitus - Type 2, sponsored by Hospital Universitario Dr. Jose E. Gonzalez. Recruiting at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-11.
Sponsored by Hospital Universitario Dr. Jose E. Gonzalez · Phase 4, Interventional, and Treatment
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.
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.
2,028 studies on the registry are indexed under Psoriasis; 275 are open to participants now.
This study's planned enrollment of 62 is below the median of 75 across 1,565 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Hospital Universitario Dr. Jose E. Gonzalez is the lead sponsor of 83 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A total of 31 participants will be randomly assigned to the semaglutide intervention group.
Drug: Semaglutide (Rybelsus®)
A total of 31 participants will be randomly assigned to the placebo intervention group.
Drug: Placebo
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).
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).
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.
Time frame: Baseline to Week 12
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and Week 12
Change in HbA1c
Change in glycated hemoglobin (HbA1c, %) from baseline to Week 12.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to Week 12
Plan to share: Yes — Upon reasonable request.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
No publications or documents are linked to this record.
Started Jan 2026 (actual). Primary completion is estimated for Feb 2027, 13 months after the start.
Of 75 non-industry phase 4 interventional studies under Psoriasis, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 49. This study's planned 13 months is below that.
Counting every sponsor, half of 115 studies reached it within 23 months; a quarter within 12 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Semaglutide
Hospital Universitario Dr. Jose E. Gonzalez