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

NCT06426446 | Not Yet Recruiting

• 1 other identifier: APHP230587
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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®.

Conditions

Obesity

Keywords

Obesity; Wegovy; Semaglutide 2.4 mg/week

Outcome Measures

Primary Outcomes (1)

• The relative difference in weight loss achieved at 6 months of treatment at the maximum tolerated dose ((weight after 6 months of treatment at the maximum tolerated dose - baseline weight) / baseline weight)

  Body weight measured at month 0 and 6

  6 months

Secondary Outcomes (14)

• The variation of body weight measured by the connected scale between participants receiving semaglutide at the maximum tolerated dose

  6 months

• The variation of body composition (fat mass, muscle mass, and bone mass) measured by the connected scale between participants receiving semaglutide at the maximum tolerated dose

  6 months

• The variation of pulse wave velocity measured by the connected scale between participants receiving semaglutide at the maximum tolerated dose

  6 months

• The variation of arterial stiffness measured by the connected scale between participants receiving semaglutide at the maximum tolerated dose

  6 months

• The variation of vascular age measured by the connected scale between participants receiving semaglutide at the maximum tolerated dose

  6 months

Study Arms (1)

Connected scale

EXPERIMENTAL

Patients receiving connected scale

Device: Withings Body Comp Pro

Interventions

Withings Body Comp Pro DEVICE

Withings Body Comp Pro from which the following features will be used: body weight, body composition (fat, muscle and bone mass, cardiovascular health (pulse wave velocity, arterial stiffness, vascular age, standing heart rate), nervous health (electrochemical skin conductance)

Connected scale

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• BPIfrance: collaborator
• Withings: collaborator

Study Sites (1)

Hôpital européen Georges Pompidou - APHP

Paris, 75015, France

Location

Related Publications (20)

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  PMID: 31383618 BACKGROUND

• Wilding JPH, Batterham RL, Calanna S, Davies M, Van Gaal LF, Lingvay I, McGowan BM, Rosenstock J, Tran MTD, Wadden TA, Wharton S, Yokote K, Zeuthen N, Kushner RF; STEP 1 Study Group. Once-Weekly Semaglutide in Adults with Overweight or Obesity. N Engl J Med. 2021 Mar 18;384(11):989-1002. doi: 10.1056/NEJMoa2032183. Epub 2021 Feb 10.

  PMID: 33567185 BACKGROUND

• Wilding JPH, Batterham RL, Calanna S, Van Gaal LF, McGowan BM, Rosenstock J, et al. Impact of Semaglutide on Body Composition in Adults With Overweight or Obesity: Exploratory Analysis of the STEP 1 Study. J Endocr Soc. 2021 May 3;5(Suppl 1):A16-7.

  BACKGROUND

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  PMID: 36200477 BACKGROUND

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  PMID: 32213703 BACKGROUND

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  PMID: 36655300 BACKGROUND

• BROWN RE, LIU AR, MAHBUBANI R, ARONSON R. 995-P: Semaglutide in Patients with Type 2 Diabetes: Real-World Analysis in the Canadian LMC Diabetes Registry: The SPARE Study. Diabetes. 2019 Jun 1;68(Supplement_1):995-P.

  BACKGROUND

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  BACKGROUND

• Di Loreto C, Minarelli V, Nasini G, Norgiolini R, Del Sindaco P. Effectiveness in Real World of Once Weekly Semaglutide in People with Type 2 Diabetes: Glucagon-Like Peptide Receptor Agonist Naive or Switchers from Other Glucagon-Like Peptide Receptor Agonists: Results from a Retrospective Observational Study in Umbria. Diabetes Ther. 2022 Mar;13(3):551-567. doi: 10.1007/s13300-022-01218-y. Epub 2022 Mar 1.

  PMID: 35230650 BACKGROUND

• Rajamand Ekberg N, Bodholdt U, Catarig AM, Catrina SB, Grau K, Holmberg CN, Klanger B, Knudsen ST. Real-world use of once-weekly semaglutide in patients with type 2 diabetes: Results from the SURE Denmark/Sweden multicentre, prospective, observational study. Prim Care Diabetes. 2021 Oct;15(5):871-878. doi: 10.1016/j.pcd.2021.06.008. Epub 2021 Jun 25.

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MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sébastien Czernichow, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Josephine BRAUN

CONTACT

01 44 84 17 38; josephine.braun@aphp.fr

Liliane HAMMANI-BERKANI

CONTACT

01 56 09 37 62; liliane.berkani@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: May 23, 2024
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: May 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Two years after the last publication
• Access Criteria: Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. The founder could be involved in the decision. Teams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization. Processing of shared data must comply with European General Data Protection Regulation (GDPR)

Locations

FR (1)