A Real-World Study on the Impact of Weight Loss on Treatment Efficacy in Overweight/Obese Patients With Plaque Psoriasis

January 28, 2026 updated by: Guo Jin-Zhu, Peking University Third Hospital

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 Overview

Study Type

Observational

Enrollment (Estimated)

70

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

Sampling Method

Non-Probability Sample

Study Population

Clinical diagnosis of plaque psoriasis and Body Mass Index (BMI) categorized as overweight or obese.

Description

Inclusion Criteria:

  1. Age ≥ 18 years, regardless of gender.
  2. Having signed the informed consent form.
  3. Clinical diagnosis of plaque psoriasis.
  4. Body Mass Index (BMI) categorized as overweight or obese.
  5. For female patients: No plans for pregnancy or oocyte donation during the study period and voluntary use of highly effective physical contraception.

Exclusion Criteria:

  1. Pregnant or lactating women.
  2. Individuals deemed by the investigator to be unsuitable for participation in this study.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Weight Loss Group
receiving standard psoriasis care plus a personalized weight management program
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.
Control Group
receiving standard psoriasis care only
Receive standardized treatment for their psoriasis based on disease severity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of PASI<3 at Week 12
Time Frame: Week 12
Proportion of patients undergoing weight loss treatment who achieve a PASI score below 3 at Week 12.
Week 12
Changes of BMI
Time Frame: Week 12 and Week 24
Changes from baseline in Body Mass Index (BMI) at Week 12 and Week 24 in patients undergoing weight loss treatment.
Week 12 and Week 24
Proportion of PGA 0/1 (Physician's Global Assessment)
Time Frame: Week 12 and Week 24
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.
Week 12 and Week 24
Proportion of DLQI<6
Time Frame: Week 12 and Week 24
Proportion of patients undergoing weight loss treatment who achieve a Dermatology Life Quality Index (DLQI) score below 6 at Week 12 and Week 24
Week 12 and Week 24

Collaborators and Investigators

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

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 (Estimated)

January 28, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

January 20, 2026

First Submitted That Met QC Criteria

January 28, 2026

First Posted (Actual)

February 2, 2026

Study Record Updates

Last Update Posted (Actual)

February 2, 2026

Last Update Submitted That Met QC Criteria

January 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • M20260001

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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