Effect of Semaglutide in Patients With Psoriasis and Obesity

Sponsor
The University of Hong Kong
Study ID
NCT06937060
Phase
PHASE3
Status
Recruiting
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Conditions

  • Obesity and Overweight
  • Psoriasis (PsO)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 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)

Study Details

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.

Key Dates

Start date
Mar 20, 2025
Status verified
Apr 2025
Primary completion
Jul 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
14 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Active (alternative intervention)
    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.

Primary Outcome Measure

Change in mean Psoriasis Area and Severity Index (PASI) before and after semaglutide treatment. [ Time Frame: 36 weeks ]

Central Contacts

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