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

May 7, 2025 updated by: Chung Man Ho Martin, The University of Hong Kong

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

14

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Man Ho Martin Chung
  • Phone Number: 22553111
  • Email: drcmhm@hku.hk

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • The University of Hong Kong, Department of Medicine
        • Contact:
          • Honorary Clinical Assistant Professor
          • Phone Number: +85222553111
          • Email: cmh327@ha.org.hk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
36 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: Man Ho Martin Chung, The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2025

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

April 15, 2025

First Submitted That Met QC Criteria

April 17, 2025

First Posted (Actual)

April 20, 2025

Study Record Updates

Last Update Posted (Actual)

May 13, 2025

Last Update Submitted That Met QC Criteria

May 7, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW 25-083

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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