Skip to content

Trial · Interventional

Status unknownNot applicableRegistry data

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

Short name TELE-SEMA

NCTNCT06426446 (opens ClinicalTrials.gov in a new tab)Other idAPHP230587
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Measures Semaglutide, does not give it. It appears in an outcome measure.

Overview

Status
Status unknown
Phase
Not applicable
Enrollment
80 participants (estimated)
Sponsor
Assistance Publique - Hôpitaux de Paris · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

France

Start
1 Jun 2024 (estimated)
Primary completion
1 Jun 2025 (estimated)
Completion
1 Jun 2025 (estimated)
First posted
23 May 2024
Last update posted
23 May 2024
Conditions
Obesity

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202420252026
  1. N/A

    TELE-SEMA

    NCT06426446

    est. 1 Jun 2024 to est. 1 Jun 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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®.

Interventions

  • Withings Body Comp ProDevice

Arms1

  • Experimental

    Connected scale

    Patients receiving connected scale

Primary outcomes1

Outcomes the sponsor listed as primary.

  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)

    Time frame · 6 months

    Registry description

    Body weight measured at month 0 and 6

Secondary outcomes(14)

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

    Time frame · 6 months

    Registry description

    Body weight measured weekly

  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

    Time frame · 6 months

    Registry description

    Body composition measured weekly

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

    Time frame · 6 months

    Registry description

    Pulse wave velocity

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

    Time frame · 6 months

    Registry description

    Arterial stiffness

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

    Time frame · 6 months

    Registry description

    Vascular age

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

    Time frame · 6 months

    Registry description

    Heart rate

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

    Time frame · 6 months

    Registry description

    Nervous system health measured weekly

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

    Time frame · 6 months

    Registry description

    Pulse wave velocity at month 0 and 6

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

    Time frame · 6 months

    Registry description

    Arterial stiffness at month 0 and 6

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

    Time frame · 6 months

    Registry description

    Vascular age at month 0 and 6

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

    Time frame · 6 months

    Registry description

    Heart rate at month 0 and 6

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

    Time frame · 6 months

    Registry description

    Eating behavior at month 0 and 6

  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

    Time frame · 6 months

    Registry description

    Level of physical activity at month 0 and 6

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

    Time frame · 6 months

    Registry description

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies8

Studies that cite this trial.

Studies with results

4 studies on this page

Indexing hint: Randomized controlled trial · 2023

12 results

Two-year effect of semaglutide 2.4 mg on control of eating in adults with overweight/obesity: STEP 5.

Wharton et al. 2023Obesity (Silver Spring, Md.)cited by 92

PMID 36655300DOI 10.1002/oby.23673PUB-36655300

Full text at the publisher12 results
Publisher pageSee results (12)

Indexing hint: Observational study · 2022

9 results

Real-world use of once-weekly semaglutide in patients with type 2 diabetes at an outpatient clinic in Spain.

Garcia de Lucas et al. 2022Frontiers in endocrinologycited by 15

PMID 36187123PMC9523693DOI 10.3389/fendo.2022.995646PUB-36187123

CC BY9 results
Download PDFSee results (9)

Indexing hint: Randomized controlled trial · 2021

10 results

Once-Weekly Semaglutide in Adults with Overweight or Obesity.

Wilding et al. 2021The New England journal of medicinecited by 3,862

PMID 33567185DOI 10.1056/nejmoa2032183PUB-33567185

Full text at the publisher10 results
Publisher pageSee results (10)

Indexing hint: Observational study · 2021

5 results

Real-world use of once-weekly semaglutide in patients with type 2 diabetes: Results from the SURE Denmark/Sweden multicentre, prospective, observational study.

Rajamand Ekberg et al. 2021Primary care diabetescited by 55

PMID 34183269DOI 10.1016/j.pcd.2021.06.008PUB-34183269

CC BY5 results
Download PDFSee results (5)

More studies

4 studies on this page

PubMed tag: none · 2023

Semaglutide improves cardiometabolic risk factors in adults with overweight or obesity: STEP 1 and 4 exploratory analyses.

Kosiborod et al. 2023Diabetes, obesity & metabolismcited by 98

PMID 36200477PMC10092593DOI 10.1111/dom.14890PUB-36200477

Free to read · publisher termsCC BY-NC
Read at source

PubMed tag: none · 2022

Corrected

Effectiveness in Real World of Once Weekly Semaglutide in People with Type 2 Diabetes: Glucagon-Like Peptide Receptor Agonist Naïve or Switchers from Other Glucagon-Like Peptide Receptor Agonists: Results from a Retrospective Observational Study in Umbria.

Di Loreto et al. 2022Diabetes therapy : research, treatment and education of diabetes and related disorderscited by 17

PMID 35230650PMC8886341DOI 10.1007/s13300-022-01218-yPUB-35230650

Free to read · publisher termsCC BY-NC
Read at sourceRead the notice

PubMed tag: none · 2022

Real-world use of once-weekly semaglutide in patients with type 2 diabetes: pooled analysis of data from four SURE studies by baseline characteristic subgroups.

Yale et al. 2022BMJ open diabetes research & carecited by 46

PMID 35383100PMC8984040DOI 10.1136/bmjdrc-2021-002619PUB-35383100

Free to read · publisher termsCC BY-NC
Read at source

Indexing hint: Animal study · 2020

Semaglutide lowers body weight in rodents via distributed neural pathways.

Gabery et al. 2020JCI insightcited by 607

PMID 32213703PMC7213778DOI 10.1172/jci.insight.133429PUB-32213703

Rights unknown
Source link

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

PepBank is a research reference. Talk to a doctor before you use any peptide.