NCT06937060 Effect of Semaglutide in Patients With Psoriasis and Obesity
| NCT ID | NCT06937060 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | The University of Hong Kong |
| Condition | Psoriasis (PsO) |
| Study Type | INTERVENTIONAL |
| Enrollment | 14 participants |
| Start Date | 2025-03-20 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 14 participants in total. It began in 2025-03-20 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Man Ho Martin Chung
PRINCIPAL INVESTIGATOR
The University of Hong Kong
Frequently Asked Questions
Who can join the NCT06937060 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Psoriasis (PsO). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06937060 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 14 participants.
Is NCT06937060 currently recruiting?
Yes, NCT06937060 is actively recruiting participants. Contact the research team at drcmhm@hku.hk for enrollment information.
Where is the NCT06937060 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong.
Who is sponsoring the NCT06937060 clinical trial?
NCT06937060 is sponsored by The University of Hong Kong. The principal investigator is Man Ho Martin Chung at The University of Hong Kong. The trial plans to enroll 14 participants.
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