PsoriasisNCT07382388
A Real-World Study on the Impact of Weight Loss on Treatment Efficacy in Overweight/Obese Patients With Plaque Psoriasis
An observational study of Psoriasis, run by Peking University Third Hospital.
Trial summary
The goal of this investigator-initiated, real-world, observational study is to investigate the impact of weight loss on treatment efficacy in overweight or obese Chinese patients with moderate-to-severe plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Weight loss and psoriasis treatment and psoriasis treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 28 Jan 2026to 31 Dec 2027
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Clinical diagnosis of plaque psoriasis and Body Mass Index (BMI) categorized as overweight or obese.
Who may be able to join
- Age ≥ 18 years, regardless of gender.
- Having signed the informed consent form.
- Clinical diagnosis of plaque psoriasis.
- Body Mass Index (BMI) categorized as overweight or obese.
- For female patients: No plans for pregnancy or oocyte donation during the study period and voluntary use of highly effective physical contraception.
Who cannot join
- Pregnant or lactating women.
- Individuals deemed by the investigator to be unsuitable for participation in this study.
About this study
The goal of this investigator-initiated, real-world, observational study is to investigate the impact of weight loss on treatment efficacy in overweight or obese Chinese patients with moderate-to-severe plaque psoriasis.
The main question it aims to answer is:
Read more
Does a structured weight loss intervention (including dietary management, exercise, and/or pharmacotherapy) improve the clinical response to psoriasis therapy in this population, as measured by the proportion of patients achieving a Psoriasis Area and Severity Index (PASI) score below 3 at Week 24?
Researchers will compare the Weight Loss Intervention Group (receiving standard psoriasis care plus a personalized weight management program) to the Control Group (receiving standard psoriasis care only) to see if the addition of weight loss strategies leads to superior improvements in psoriasis severity, metabolic parameters, and quality of life.
Participants will:
Receive standardized treatment for their psoriasis based on disease severity.
Be allocated (based on patient preference and clinical judgment) to either the intervention or control group.
In the intervention group, receive and follow a personalized weight management plan, which may include dietary counseling, a tailored exercise regimen, and/or Glucagon-Like Peptide-1（GLP-1） receptor agonist therapy (e.g., Semaglutide, Tirzepatide) if indicated.
Undergo scheduled assessments at baseline, Week 12, and Week 24, including:
Clinical evaluations (PASI, Physician's Global Assessment, body surface area).
Anthropometric measurements (weight, BMI, waist/hip circumference).
Quality of life assessment (Dermatology Life Quality Index).
Safety monitoring for adverse events. To investigate the impact of weight loss on treatment efficacy among overweight/obese Chinese patients with plaque psoriasis.
- Conditions
- Psoriasis
- Being tested
- Weight loss and psoriasis treatment, psoriasis treatment
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight loss and psoriasis treatmentCombination product
In the weight loss group, receive standardized treatment for their psoriasis based on disease severity and follow a personalized weight management plan, which may include dietary counseling, a tailored exercise regimen, and/or GLP-1 receptor agonist therapy (e.g., Semaglutide, Tirzepatide) if indicated.
psoriasis treatmentCombination product
Receive standardized treatment for their psoriasis based on disease severity.
| Study group | Role | What they receive |
|---|---|---|
| Weight Loss Group | receiving standard psoriasis care plus a personalized weight management program Receives: Combination Product: Weight loss and psoriasis treatment | |
| Control Group | receiving standard psoriasis care only Receives: Combination Product: psoriasis treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of PASI<3 at Week 24
Proportion of patients undergoing weight loss treatment who achieve a Psoriasis Area and Severity Index (PASI) score below 3 at Week 24.
Measured: Week 24
Secondary outcomes (4)
Proportion of PASI<3 at Week 12
Proportion of patients undergoing weight loss treatment who achieve a PASI score below 3 at Week 12.
Measured: Week 12
Changes of BMI
Changes from baseline in Body Mass Index (BMI) at Week 12 and Week 24 in patients undergoing weight loss treatment.
Measured: Week 12 and Week 24
Proportion of PGA 0/1 (Physician's Global Assessment)
Proportion of patients undergoing weight loss treatment who achieve a Physician's Global Assessment (PGA) score of 0 or 1 at Week 12 and Week 24.
Measured: Week 12 and Week 24
Proportion of DLQI<6
Proportion of patients undergoing weight loss treatment who achieve a Dermatology Life Quality Index (DLQI) score below 6 at Week 12 and Week 24
Measured: Week 12 and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start28 Jan 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guo Jin-Zhu, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07382388
- Sponsor's protocol ID
- M20260001
- Status last verified
- Jan 2026
- First submitted
- 20 Jan 2026
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-World Study on the Impact of Weight Loss on Treatment Efficacy in Overweight/Obese Patients With Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT07382388
- Acronym / sponsor ID
- M20260001
- Conditions
- Psoriasis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 28 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Feb 2026 (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.
The goal of this investigator-initiated, real-world, observational study is to investigate the impact of weight loss on treatment efficacy in overweight or obese Chinese patients with moderate-to-severe plaque psoriasis.
The main question it aims to answer is:
Does a structured weight loss intervention (including dietary management, exercise, and/or pharmacotherapy) improve the clinical response to psoriasis therapy in this population, as measured by the proportion of patients achieving a Psoriasis Area and Severity Index (PASI) score below 3 at Week 24?
Researchers will compare the Weight Loss Intervention Group (receiving standard psoriasis care plus a personalized weight management program) to the Control Group (receiving standard psoriasis care only) to see if the addition of weight loss strategies leads to superior improvements in psoriasis severity, metabolic parameters, and quality of life.
Participants will:
Receive standardized treatment for their psoriasis based on disease severity.
Be allocated (based on patient preference and clinical judgment) to either the intervention or control group.
In the intervention group, receive and follow a personalized weight management plan, which may include dietary counseling, a tailored exercise regimen, and/or Glucagon-Like Peptide-1（GLP-1） receptor agonist therapy (e.g., Semaglutide, Tirzepatide) if indicated.
Undergo scheduled assessments at baseline, Week 12, and Week 24, including:
Clinical evaluations (PASI, Physician's Global Assessment, body surface area).
Anthropometric measurements (weight, BMI, waist/hip circumference).
Quality of life assessment (Dermatology Life Quality Index).
Safety monitoring for adverse events. To investigate the impact of weight loss on treatment efficacy among overweight/obese Chinese patients with plaque psoriasis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weight Loss Group | – | Combination Product: Weight loss and psoriasis treatmentreceiving standard psoriasis care plus a personalized weight management program |
| Control Group | – | Combination Product: psoriasis treatmentreceiving standard psoriasis care only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clinical diagnosis of plaque psoriasis and Body Mass Index (BMI) categorized as overweight or obese.
Key inclusion criteria (5 listed)
- Age ≥ 18 years, regardless of gender.
- Having signed the informed consent form.
- Clinical diagnosis of plaque psoriasis.
- Body Mass Index (BMI) categorized as overweight or obese.
- For female patients: No plans for pregnancy or oocyte donation during the study period and voluntary use of highly effective physical contraception.
Key exclusion criteria (2 listed)
- Pregnant or lactating women.
- Individuals deemed by the investigator to be unsuitable for participation in this study.
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 |
|---|---|---|
| Weight loss and psoriasis treatmentIn the weight loss group, receive standardized treatment for their psoriasis based on disease severity and follow a personalized weight management plan, which may include dietary counseling, a tailored exercise regimen, and/or GLP-1 receptor agonist therapy (e.g., Semaglutide, Tirzepatide) if indicated. | Combination product | Weight Loss Group |
| psoriasis treatmentReceive standardized treatment for their psoriasis based on disease severity. | Combination product | Control Group |
Primary outcome
Proportion of PASI<3 at Week 24
Time frame: Week 24
Proportion of patients undergoing weight loss treatment who achieve a Psoriasis Area and Severity Index (PASI) score below 3 at Week 24.
4 secondary outcomes
Proportion of PASI<3 at Week 12
Time frame: Week 12
Changes of BMI
Time frame: Week 12 and Week 24
Proportion of PGA 0/1 (Physician's Global Assessment)
Time frame: Week 12 and Week 24
Proportion of DLQI<6
Time frame: Week 12 and Week 24
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 2 Feb 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by Peking University Third Hospital.
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 5 inclusion and 2 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: opening soon, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of PASI<3 at Week 24 (time frame: Week 24). 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 2 Feb 2026; AzTrials last refreshed its copy on 7 Nov 2026.