Clinical trial NCT06937060: Effect of Semaglutide in Patients With Psoriasis and Obesity
Official title: Effect of Semaglutide in Patients With Psoriasis and Obesity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Psoriasis (PsO)
Obesity and Overweight
Keywords: semaglutide
obesity
psoriasis
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2025-04-20
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in mean Psoriasis Area and Severity Index (PASI) before and after semaglutide treatment.
timeFrame: 36 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong, Department of Medicine
Study officials:
affiliation: The University of Hong Kong
name: Man Ho Martin Chung
role: PRINCIPAL_INVESTIGATOR
References: