Effect of Semaglutide in Patients With Psoriasis and Obesity (SEMPSO)

The University of Hong Kong (HKU)

Status and phase: Enrolling; Phase 3

Conditions: Obesity and Overweight; Psoriasis (PsO)

Treatments: Biological: semaglutide

Study type: Interventional

Funder types: Other

Identifiers

NCT06937060

UW 25-083

Details and patient eligibility

About

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.

Enrollment: 14 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Active (alternative intervention)

Experimental group

Description:

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.

Treatment:

Biological: semaglutide