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NCT Number: NCT07382388

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Weight loss and psoriasis treatment

Combination 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 treatment

Combination Product

Receive standardized treatment for their psoriasis based on disease severity.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 2, 2026
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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