Psoriasis (PsO)Phase 3SEMPSONCT06937060
Effect of Semaglutide in Patients With Psoriasis and Obesity
A Phase 3 study testing semaglutide in people with Psoriasis (PsO) and Obesity and Overweight, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psoriasis (PsO), Obesity and Overweight
- What is being tested?
- semaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteHong Kong
- Study dates
- 20 Mar 2025to 31 Jan 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The University of Hong Kong, Department of Medicine
Hong Kong
Honorary Clinical Assistant Professor, +85222553111, cmh327@ha.org.hk
About this study
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.
Read more
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
- Being tested
- semaglutide
- Keywords
- semaglutide, obesity, psoriasis
- Medical subject headings
- Psoriasis, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semaglutideBiological
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start20 Mar 2025
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis (PsO)Studies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chung Man Ho Martin, The University of Hong Kong
- Investigators
- Man Ho Martin Chung, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06937060
- Sponsor's protocol ID
- UW 25-083
- Acronym
- SEMPSO
- Status last verified
- Apr 2025
- First submitted
- 15 Apr 2025
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Semaglutide in Patients With Psoriasis and Obesity
- ClinicalTrials.gov ID
- NCT06937060
- Acronym / sponsor ID
- SEMPSO / UW 25-083
- Conditions
- Psoriasis (PsO), Obesity and Overweight
- Keywords
- semaglutide, obesity, psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 20 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active (alternative intervention) | Experimental | Biological: semaglutideSemaglutide 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| semaglutideSemaglutide 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) | Biological | Active (alternative intervention) |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Man Ho Martin Chung principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing semaglutide in people with Psoriasis (PsO) and Obesity and Overweight, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Man Ho Martin Chung (22553111, drcmhm@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean Psoriasis Area and Severity Index (PASI) before and after semaglutide treatment. (time frame: 36 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.