A Phase 3 interventional study of semaglutide in Psoriasis (PsO) and Obesity and Overweight, sponsored by The University of Hong Kong. Recruiting at 1 site in Hong Kong. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-05-13.
Sponsored by The University of Hong Kong · Phase 3, Interventional, and Treatment
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.
1,928 studies on the registry are indexed under Psoriasis; 234 are open to participants now.
This study's planned enrollment of 14 is below the median of 70 across 1,472 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →The University of Hong Kong is the lead sponsor of 1,286 studies on the registry; 343 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Semaglutide is act as an adjunct to a reduced calorie diet and increase physical activity for chronic weight management in obesity or overweighted adult. Initiate Semaglutide with a dosage of 0.25 mg injected subcutaneously once-weekly, from week 1 to week 24, i.e. 24 dosage of Semaglutide in total.
Biological: semaglutide
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)
Change in mean Psoriasis Area and Severity Index (PASI) before and after semaglutide treatment.
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.
Time frame: 36 weeks
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Studies of the drug tested here: Semaglutide