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NCT Number: NCT06937060

Effect of Semaglutide in Patients With Psoriasis and Obesity

Obesity is well known to be an important comorbidity of psoriasis. It gives rise to higher risk of psoriatic arthritis, more severe disease and also poorer response to biologics. Weight loss can lead to reduction in psoriasis severity. Previous studies had demonstrated the efficacy of older glucagon-like peptide-1 receptor agonist (GLP1 RA) on improvement of psoriatic disease activity. Effective weight loss has been achieved by newer GLP1 RA.7 It is also known to reduce cardiovascular outcomes in patient without diabetes. Trials on the effect of semaglutide on psoriasis has not been performed except case reports.

Semaglutide is an injectable prescription medicine that may help adults and children aged 12 years and older with obesity or some adults with excess weight (overweight) who also have weight-related medical problem to help them lose weight. It contains a GLP1 RA indicated as an adjunct to diet and exercise to improve glycemic control. It has potential anti-inflammatory effects on top of weight reduction, that may lead to improvement in psoriatic disease activity.

This is an open-label, single-armed, prospective pilot trial on obese, psoriasis patients. The investigators aim to recruit 14 patients. Patients will be maintained on standard care for their psoriasis. Add-on treatment with semaglutide of up to 2.0mg per week will be administered to the intervention arm in addition to lifestyle intervention. Treatment with previous systemic immunosuppressants is allowed.

The maximum study duration for a single subject in the study will be approximately 36 weeks, 4 weeks of screening, 24-week treatment period, and a 12-week safety follow up period after the last study dose of semaglutide at week 24.

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Key information

Conditions

Psoriasis (PsO) Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity and Overweight Overnutrition Overweight Pathological Conditions, Signs and Symptoms Psoriasis Signs and Symptoms Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The University of Hong Kong, Department of Medicine

Hong Kong

Location status: Recruiting

Location contact

Honorary Clinical Assistant Professor

CONTACT

[email protected]

+85222553111

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

a clinical diagnosed Psoriatic disease of at least 6 months before signing of informed consent.
Women who are sexually active and not postmenopausal, agreement to remain abstinent or use 2 effective methods of contraception
>18 years of age, up to 75 years of age
Adult with an initial body mass index (BMI) of 30 kg/m2 or greater (obesity) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia)
Moderate to severe psoriasis (PASI score 5-10= moderate, >10 = severe)
Chinese ethnicity
On stable dose of standard treatment
Ability to comply with stud

Exclusion criteria

Patients who refuse to give consent
Contraindication to use of GLP1 RA
History of pancreatitis
History of MEN / MTC
Known hypersensitivity to semaglutide or excipients in semaglutide
Type 1 diabetes
Gallbladder disease
Active malignancy or History of malignancy within 5 years
Active chronic or acute infection requiring treatment with systemic antibiotics, antiviral, antiparasitic, antiprotozoal, or antifungals within 4 weeks before baseline visit
Pregnancy or breastfeeding, subjects should inform their healthcare provider of a known or suspected pregnancy
History of allergic reaction assessed as related to investigational product by the investigator
Major psychiatric illness
Treatment with live/ attenuated vaccine within the last 28 days prior to randomisation
History of alcohol or substance abuse within 6 months prior to initial screening
Patients with a history of suicidal attempts or active suicidal ideation

Treatment and study plan

Semaglutide

Biological

Semaglutide is act as an adjunct to a reduced calorie diet and increase physical activity for chronic weight management in adult with an initial body mass index (BMI) of 30 kg/m2 or greater (obesity) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia)

Primary outcomes

Change in mean Psoriasis Area and Severity Index (PASI) before and after semaglutide treatment.

Time frame: 36 weeks

The change in mean Psoriasis Area and Severity Index (PASI) score before and after semaglutide treatment will be assessed. The PASI score is a widely used tool to measure the severity and extent of psoriasis. It combines the assessment of the severity of lesions (erythema, induration, and desquamation) and the area affected into a single score. The PASI score ranges from 0 to 72, where 0 indicates no disease and 72 represents the most severe disease.

Study contacts

Contact information is provided by the study sponsor or research team.

Man Ho Martin Chung

CONTACT

[email protected]

22553111

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Acronym: SEMPSO

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2027
First posted: Apr 20, 2025
Registry last updated: May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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