Effect of Semaglutide in Patients With Psoriasis and Obesity

NCT06937060 | Recruiting Phase 3

• 1 other identifier: UW 25-083
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Psoriasis (PsO); Obesity and Overweight

Keywords

semaglutide; obesity; psoriasis

Outcome Measures

Primary Outcomes (1)

• 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.

  36 weeks

Study Arms (1)

Active (alternative intervention)

EXPERIMENTAL

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

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)

Active (alternative intervention)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong, Department of Medicine

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Psoriasis; Obesity; Overweight

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Man Ho Martin Chung

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Man Ho Martin Chung

CONTACT

22553111; drcmhm@hku.hk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Honorary Clinical Assistant Professor

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: April 20, 2025
• Study Start: March 20, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: May 13, 2025

Record last verified: 2025-04

Locations

HK (1)