Monitoring Patients With Severe Obesity Treated With Wegovy® Using Connected Device: Real-world Data (TELE-SEMA)

Assistance Publique - Hôpitaux de Paris

Status: Not yet enrolling

Conditions: Obesity

Treatments: Device: Withings Body Comp Pro

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06426446

APHP230587

Details and patient eligibility

About

This study involves collecting real-world data on body weight, body composition, cardiovascular parameters, and neurovegetative parameters using a connected scale in patients with severe obesity treated with Wegovy®.

Full description

Obesity is a chronic disease associated with numerous co-morbidities. New treatments for obesity, notably GLP-1 (Glucagon-like peptide 1) analogs, have led to promising advances. Semaglutide 2.4 mg weekly subcutaneous injection, marketed under the brand name Wegovy®, was recently approved in France for weight loss in patients with severe obesity and at least one comorbidity. Several real-world studies have confirmed the effectiveness of semaglutide in reducing body weight and HbA1c. However, few studies have evaluated the kinetics and interindividual variability of changes in body weight and composition as well as cardiovascular health. There appears to be a need for a comprehensive real-world assessment of patients living with severe obesity receiving Wegovy®.

The TELE-SEMA project involves collecting real-world data on body weight, body composition, cardiovascular and neurovegetative parameters via connected scales in patients with severe obesity treated with Wegovy®.

The main objectives will be to assess inter-individual weight variability and explore the determinants that may influence weight loss, body composition and possible eating disorders.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Man or woman aged over 18 years
• Patients who have reached the maximum dose of their treatment with Wegovy®
• Written consent

Exclusion criteria

• Patient on AME (state medical aid)
• Pregnant or breastfeeding woman
• Patient who does not speak French
• Adults under legal protection

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Connected scale

Experimental group

Description:

Patients receiving connected scale

Treatment:

Device: Withings Body Comp Pro