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

Peking University

Status: Not yet enrolling

Conditions: Psoriasis

Treatments: Combination Product: psoriasis treatment; Combination Product: Weight loss and psoriasis treatment

Study type: Observational

Funder types: Other

Identifiers

NCT07382388

M20260001

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

70 participants in 2 patient groups

Weight Loss Group

Description:

receiving standard psoriasis care plus a personalized weight management program

Treatment:

Combination Product: Weight loss and psoriasis treatment

Control Group

Description:

receiving standard psoriasis care only

Treatment:

Combination Product: psoriasis treatment