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SEMAPSO

RecruitingPhase 4

Effects of Semaglutide on Clinical Outcomes and Metabolic Inflammation in Psoriasis

Effects of Semaglutide on Clinical Outcomes and Metabolic Inflammation in Psoriasis: A Randomized, Triple-Blind, Placebo-Controlled Clinical Trial

Lead sponsor

Hospital Universitario Dr. Jose E. Gonzalez

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Obesity / overweight, Psoriasis / psoriatic arthritis

Key I/E criteria

•BMI ≥25•HbA1c ≤9%

Primary endpoint

•Effect of GLP-1 Receptor Agonists on SCD-1 Activity

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07401992

Org study IDDE26-00001

Timeline

Milestones

Study start2026-01-15actual

Study first posted2026-02-11actual

Last update posted2026-02-11actual

Primary completion2027-02-28estimated

Study completion2027-02-28estimated

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Obesity / overweightPsoriasis / psoriatic arthritis

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (56)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Cardiometabolic biomarkers

Weight & body composition

Other clinical outcomes

Patient-reported / QoL

Glycemic / diabetes

Safety / tolerability / PK

Weight & body composition

10 endpoints

Secondary/protocol endpoint

Change in Body Weight

Time frame:Baseline and Week 12

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in Body Weight in Participants with Type 2 Diabetes

Time frame:Baseline and Week 12

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in Body Mass Index (BMI)

Time frame:Baseline and week 12

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Waist Circumference

Time frame:Baseline and Week 12

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Hip Circumference

Time frame:Baseline and Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change in Waist-to-Hip Ratio

Time frame:Baseline and Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change in Body Mass Index (BMI) by Diabetes Status

Time frame:Baseline and Week 12

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Body Weight in Participants without Type 2 Diabetes

Time frame:Baseline to Week 12

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in Body Mass Index (BMI) in Participants with Type 2 Diabetes

Time frame:Baseline to Week 12

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Body Mass Index (BMI) in Participants without Type 2 Diabetes

Time frame:Baseline to Week 12

BMI, change

change from baseline, improvement

Glycemic / diabetes

2 endpoints

Secondary/protocol endpoint

Change in Fasting Plasma Glucose

Time frame:Baseline and Week 12

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in HbA1c

Time frame:Baseline to Week 12

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Cardiometabolic biomarkers

16 endpoints

Primary/protocol endpoint/low confidence

Effect of GLP-1 Receptor Agonists on SCD-1 Activity

Time frame:Baseline to Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change in Total Cholesterol

Time frame:Baseline and Week 12

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change in Serum Interleukin-6 (IL-6)

Time frame:Baseline and Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change in Blood Pressure

Time frame:Baseline and Week 12

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change in Serum Tumor Necrosis Factor-Alpha (TNF-α)

Time frame:Baseline and Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change in Serum C-Reactive Protein (CRP)

Time frame:Baseline and Week 12

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Secondary/protocol endpoint

Change in Serum CRP by Diabetes Status

Time frame:Baseline and Week 12

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Secondary/protocol endpoint

Change in HDL Cholesterol

Time frame:Baseline to Week 12

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change in LDL Cholesterol

Time frame:Baseline to Week 12

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Change in VLDL Cholesterol

Time frame:Baseline to Week 12

VLDL, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Triglycerides

Time frame:Baseline to Week 12

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change in Serum TNF-α in Participants with Type 2 Diabetes

Time frame:Baseline to Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change in Serum TNF-α in Participants without Type 2 Diabetes

Time frame:Baseline to Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change in Serum C-Reactive Protein (CRP) in Participants with Type 2 Diabetes

Time frame:Baseline to Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change in Serum C-Reactive Protein (CRP) in Participants without Type 2 Diabetes

Time frame:Baseline to Week 12

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Secondary/protocol endpoint

Change in Erythrocyte Sedimentation Rate (ESR) in Participants with Type 2 Diabetes

Time frame:Baseline to Week 12

change from baseline, improvement

Patient-reported / QoL

4 endpoints

Secondary/protocol endpoint

Change in Dermatology Life Quality Index (DLQI)

Time frame:Baseline and Week 12

change from baseline, improvement

Secondary/protocol endpoint

Correlation Between Psoriasis Severity and Quality of Life Measures

Time frame:Baseline to Week 12

descriptive

Secondary/protocol endpoint

Change in PROMIS-29 Profile Score

Time frame:Baseline and Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change in EQ-5D-5L Index Score

Time frame:Baseline and Week 12

EQ-5D index

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Incidence and Type of Adverse Events

Time frame:Up to Week 12

Treatment-emergent AEs (any)

event count, event

Other clinical outcomes

5 endpoints

Secondary/protocol endpoint/low confidence

Proportion of Participants Achieving Psoriasis Area and Severity Index (PASI) 75

Time frame:Weeks 4, 8, and 12

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

Correlation Between PASI and Inflammatory Biomarkers

Time frame:Baseline to Week 12

descriptive

Secondary/protocol endpoint

PASI Response by Type 2 Diabetes Status

Time frame:Baseline to Week 12

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

Correlation Between Baseline Glycemic Control and Change in Psoriasis Severity

Time frame:Baseline to Week 12

change from baseline, improvement

Secondary/protocol endpoint

Time to First Achievement of PASI 75

Time frame:Up to Week 12

time to event, improvement

Other (unclassified)

18 endpoints

Secondary/protocol endpoint/low confidence

Correlation Between Metabolic Parameters and PASI Improvement

Time frame:Baseline to Week 12

descriptive

Secondary/protocol endpoint/low confidence

Change in Serum IL-6 by Diabetes Status

Time frame:Baseline and Week 12

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Serum Interleukin-17 (IL-17)

Time frame:Baseline and Week 12

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Serum Interleukin-23 (IL-23)

Time frame:Baseline and Week 12

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Erythrocyte Sedimentation Rate (ESR)

Time frame:Baseline and Week 12

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Correlation Between Baseline Glycemic Control and Change in Metabolic Parameters

Time frame:Baseline to Week 12

descriptive

Secondary/protocol endpoint/low confidence

Change in Acylcarnitine Profile by Diabetes Status

Time frame:Baseline and Week 12

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in Serum IL-17 by Diabetes Status

Time frame:Baseline and Week 12

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Serum IL-23 by Diabetes Status

Time frame:Baseline and Week 12

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Serum TNF-α by Diabetes Status

Time frame:Baseline and Week 12

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in ESR by Diabetes Status

Time frame:Baseline and Week 12

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Serum IL-6 in Participants with Type 2 Diabetes

Time frame:Baseline to Week 12

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Serum IL-6 in Participants without Type 2 Diabetes

Time frame:Baseline to Week 12

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Serum IL-17 in Participants without Type 2 Diabetes

Time frame:Baseline to Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change in Serum IL-17 in Participants with Type 2 Diabetes

Time frame:Baseline to Week 12

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Serum IL-23 in Participants with Type 2 Diabetes

Time frame:Baseline to Week 12

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Serum IL-23 in Participants without Type 2 Diabetes

Time frame:Baseline to Week 12

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Erythrocyte Sedimentation Rate (ESR) in Participants without Type 2 Diabetes

Time frame:Baseline to Week 12

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.