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

NCT07382388 | Not Yet Recruiting DMC

• 1 other identifier: M20260001
• Study Type: observational
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 24

Secondary Outcomes (4)

• Proportion of PASI<3 at Week 12

  Week 12

• Changes of BMI

  Week 12 and Week 24

• Proportion of PGA 0/1 (Physician's Global Assessment)

  Week 12 and Week 24

• Proportion of DLQI<6

  Week 12 and Week 24

Study Arms (2)

Weight Loss Group

receiving standard psoriasis care plus a personalized weight management program

Combination Product: Weight loss and psoriasis treatment

Control Group

receiving standard psoriasis care only

Combination Product: psoriasis treatment

Interventions

psoriasis treatment COMBINATION_PRODUCT

Receive standardized treatment for their psoriasis based on disease severity.

Control Group

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.

Weight Loss Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Peking University Third Hospital: lead

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: February 2, 2026
• Study Start: January 28, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 2, 2026

Record last verified: 2026-01