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ObesityTELE-SEMANCT06426446

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

A study testing Withings Body Comp Pro in people with Obesity, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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®. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity
What is being tested?
Withings Body Comp Pro
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteFrance
Study dates
1 Jun 2024to 1 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

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

France1 site

  • Hôpital européen Georges Pompidou - APHP

    Paris, 75015

    Sébastien Czernichow, MD, PhD, sebastien.czernichow@aphp.fr

    Nathalie Alrassy, PhD, nathalie.alrassy@aphp.fr

Other trials in France

About this study

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®.

Read the detailed 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.

Conditions
Obesity
Being tested
Withings Body Comp Pro
Keywords
Obesity, Wegovy, Semaglutide 2.4 mg/week
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Withings Body Comp ProDevice

    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)

Study groups in NCT06426446
Study groupRoleWhat they receive
Connected scaleExperimentalPatients receiving connected scale
Receives: Device: Withings Body Comp Pro

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 6 months

Secondary outcomes (14)

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

    Body weight measured weekly

    Measured: 6 months

  2. 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

    Body composition measured weekly

    Measured: 6 months

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

    Pulse wave velocity

    Measured: 6 months

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

    Arterial stiffness

    Measured: 6 months

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

    Vascular age

    Measured: 6 months

  6. The variation of heart rate measured by the connected scale between participants receiving semaglutide at the maximum tolerated dose

    Heart rate

    Measured: 6 months

  7. The variation of nervous system health (electrochemical skin conductance) measured by the connected scale between participants receiving semaglutide at the maximum tolerated dose

    Nervous system health measured weekly

    Measured: 6 months

  8. Difference in mean pulse wave velocity before and after 6 months of treatment with semaglutide at the maximum tolerated dose

    Pulse wave velocity at month 0 and 6

    Measured: 6 months

  9. Difference in mean arterial stiffness before and after 6 months of treatment with semaglutide at the maximum tolerated dose

    Arterial stiffness at month 0 and 6

    Measured: 6 months

  10. Difference in mean vascular age before and after 6 months of treatment with semaglutide at the maximum tolerated dose

    Vascular age at month 0 and 6

    Measured: 6 months

  11. Difference in mean heart rate before and after 6 months of treatment with semaglutide at the maximum tolerated dose

    Heart rate at month 0 and 6

    Measured: 6 months

  12. Difference in eating behavior assessed by the BES questionnaire before and after 6 months of treatment with semaglutide at the maximum tolerated dose

    Eating behavior at month 0 and 6

    Measured: 6 months

  13. Difference in the level of physical activity assessed by the IPAQ short version questionnaire before and after 6 months of treatment with semaglutide at the maximum tolerated dose

    Level of physical activity at month 0 and 6

    Measured: 6 months

  14. Percentage of missed doses compared to the total number of prescribed doses after 6 months of treatment at the maximum tolerated dose

    missed doses compared to the total number of prescribed doses at month 6

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2024
  2. Study start1 Jun 2024 (estimated)
  3. Primary completion1 Jun 2025 (estimated)
  4. Study completion1 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06426446
Sponsor's protocol ID
APHP230587
Acronym
TELE-SEMA
Status last verified
Apr 2024
First submitted
13 May 2024
Last updated
23 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

Publications

  • World Obesity Federation. World obesity atlas 2022. Ludgate House, London; 2022.

  • ANAES. Rapport sur la chirurgie de l'obésité morbide de l'adulte. 2001.

  • Czernichow S, Renuy A, Rives-Lange C, Carette C, Airagnes G, Wiernik E, Ozguler A, Kab S, Goldberg M, Zins M, Matta J. Evolution of the prevalence of obesity in the adult population in France, 2013-2016: the Constances study. Sci Rep. 2021 Jul 8;11(1):14152. doi: 10.1038/s41598-021-93432-0.

    PubMed 34238998

  • Pan A, Sun Q, Czernichow S, Kivimaki M, Okereke OI, Lucas M, Manson JE, Ascherio A, Hu FB. Bidirectional association between depression and obesity in middle-aged and older women. Int J Obes (Lond). 2012 Apr;36(4):595-602. doi: 10.1038/ijo.2011.111. Epub 2011 Jun 7.

    PubMed 21654630

  • Schneider P, Popkin B, Shekar M, Eberwein JD, Block C, Okamura KS. Health and Economic Impacts of Overweight/Obesity. In: Obesity: Health and Economic Consequences of an Impending Global Challenge [Internet]. The World Bank; 2020 [cited 2021 Nov 5]. p. 69-94. (Human Development Perspectives). Available from: https://elibrary.worldbank.org/doi/10.1596/978-1-4648-1491-4_ch3

  • Thereaux J, Lesuffleur T, Czernichow S, Basdevant A, Msika S, Nocca D, Millat B, Fagot-Campagna A. Long-term adverse events after sleeve gastrectomy or gastric bypass: a 7-year nationwide, observational, population-based, cohort study. Lancet Diabetes Endocrinol. 2019 Oct;7(10):786-795. doi: 10.1016/S2213-8587(19)30191-3. Epub 2019 Aug 2.

    PubMed 31383618

  • 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.

    PubMed 33567185

  • 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.

  • Kosiborod MN, Bhatta M, Davies M, Deanfield JE, Garvey WT, Khalid U, Kushner R, Rubino DM, Zeuthen N, Verma S. Semaglutide improves cardiometabolic risk factors in adults with overweight or obesity: STEP 1 and 4 exploratory analyses. Diabetes Obes Metab. 2023 Feb;25(2):468-478. doi: 10.1111/dom.14890. Epub 2022 Oct 28.

    PubMed 36200477

  • Gabery S, Salinas CG, Paulsen SJ, Ahnfelt-Ronne J, Alanentalo T, Baquero AF, Buckley ST, Farkas E, Fekete C, Frederiksen KS, Helms HCC, Jeppesen JF, John LM, Pyke C, Nohr J, Lu TT, Polex-Wolf J, Prevot V, Raun K, Simonsen L, Sun G, Szilvasy-Szabo A, Willenbrock H, Secher A, Knudsen LB, Hogendorf WFJ. Semaglutide lowers body weight in rodents via distributed neural pathways. JCI Insight. 2020 Mar 26;5(6):e133429. doi: 10.1172/jci.insight.133429.

    PubMed 32213703

  • Wharton S, Batterham RL, Bhatta M, Buscemi S, Christensen LN, Frias JP, Jodar E, Kandler K, Rigas G, Wadden TA, Garvey WT. Two-year effect of semaglutide 2.4 mg on control of eating in adults with overweight/obesity: STEP 5. Obesity (Silver Spring). 2023 Mar;31(3):703-715. doi: 10.1002/oby.23673. Epub 2023 Jan 18.

    PubMed 36655300

  • 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.

  • VISARIA J, DANG-TAN T, PETRARO PV, NEPAL BK, WILLEY V. 1006-P: Real-World Effectiveness of Semaglutide in Early Users from a U.S. Commercially Insured (CI) and Medicare Advantage (MA) Population. Diabetes. 2019 Jun 1;68(Supplement_1):1006-P.

  • 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.

    PubMed 35230650

  • 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.

    PubMed 34183269

Questions about this trial

What is this clinical trial studying?

A study testing Withings Body Comp Pro in people with Obesity, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Josephine BRAUN (01 44 84 17 38, josephine.braun@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06426446, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2024.

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