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TELE-SEMA

UnknownPhase NA

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

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Asset

Semaglutide

GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

estimated

Study population

Obesity / overweight

Key I/E criterion

—

Primary endpoint

•Body weight, % change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06426446

Org study IDAPHP230587

Timeline

Milestones

Study first posted2024-05-23actual

Last update posted2024-05-23actual

Study start2024-06-01estimated

Primary completion2025-06-01estimated

Study completion2025-06-01estimated

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (15)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiometabolic biomarkers

Weight & body composition

Patient-reported / QoL

Other clinical outcomes

Other (unclassified)

Weight & body composition

3 endpoints

Primary/protocol endpoint

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

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:6 months

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint/low confidence

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

change from baseline, improvement

Cardiometabolic biomarkers

7 endpoints

Secondary/protocol endpoint

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

Time frame:6 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

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

Time frame:6 months

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:6 months

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:6 months

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:6 months

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:6 months

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:6 months

Heart rate, change

change from baseline, improvement

Patient-reported / QoL

2 endpoints

Secondary/protocol endpoint

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

change from baseline, improvement

Secondary/protocol endpoint

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

change from baseline, improvement

Other clinical outcomes

2 endpoints

Secondary/protocol endpoint/low confidence

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

change from baseline, improvement

Secondary/protocol endpoint/low confidence

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

descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

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

Time frame:6 months

change from baseline, improvement

Publications (14)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Two-year effect of semaglutide 2.4 mg on control of eating in adults with overweight/obesity: STEP 5.
Obesity (Silver Spring, Md.)2023 Mar (month)PMID36655300doi:10.1002/oby.23673via CT.gov background
Semaglutide improves cardiometabolic risk factors in adults with overweight or obesity: STEP 1 and 4 exploratory analyses.
Diabetes, obesity & metabolism2023 Feb (month)PMID36200477doi:10.1111/dom.14890via CT.gov background
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.
BMJ open diabetes research & care2022 Apr (month)PMID35383100doi:10.1136/bmjdrc-2021-002619via CT.gov background
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.
Diabetes therapy : research, treatment and education of diabetes and related disorders2022 Mar (month)PMID35230650doi:10.1007/s13300-022-01218-yvia CT.gov background
Real-world use of once-weekly semaglutide in patients with type 2 diabetes at an outpatient clinic in Spain.
Frontiers in endocrinology2022 (year)PMID36187123doi:10.3389/fendo.2022.995646via CT.gov background
Real-world use of once-weekly semaglutide in patients with type 2 diabetes: Results from the SURE Denmark/Sweden multicentre, prospective, observational study.
Primary care diabetes2021 Oct (month)PMID34183269doi:10.1016/j.pcd.2021.06.008via CT.gov background
Evolution of the prevalence of obesity in the adult population in France, 2013-2016: the Constances study.
Scientific reports2021 Jul 8PMID34238998doi:10.1038/s41598-021-93432-0via CT.gov background
Once-Weekly Semaglutide in Adults with Overweight or Obesity.
The New England journal of medicine2021 Mar 18PMID33567185doi:10.1056/NEJMoa2032183via CT.gov background
Development and Validation of a Software Linked to an Internet Portal That Facilitates the Medical Treatment and Empowerment of Patients with Type 2 Diabetes, Interaction with Medical Personnel, and the Generation of a Real-Time Registry.
Journal of diabetes science and technology2021 Mar (month)PMID32814459doi:10.1177/1932296820949941via CT.gov background
Semaglutide lowers body weight in rodents via distributed neural pathways.
JCI insight2020 Mar 26PMID32213703doi:10.1172/jci.insight.133429via CT.gov background
Long-term adverse events after sleeve gastrectomy or gastric bypass: a 7-year nationwide, observational, population-based, cohort study.
The lancet. Diabetes & endocrinology2019 Oct (month)PMID31383618doi:10.1016/S2213-8587(19)30191-3via CT.gov background
Web-Based Digital Health Interventions for Weight Loss and Lifestyle Habit Changes in Overweight and Obese Adults: Systematic Review and Meta-Analysis.
Journal of medical Internet research2019 Jan 8PMID30622090doi:10.2196/jmir.9609via CT.gov background
Bidirectional association between depression and obesity in middle-aged and older women.
International journal of obesity (2005)2012 Apr (month)PMID21654630doi:10.1038/ijo.2011.111via CT.gov background
H.E.A.L.T.H.: efficacy of an internet/population-based behavioral weight management program for the U.S. Army.
Journal of diabetes science and technology2011 Jan 1PMID21303642doi:10.1177/193229681100500125via CT.gov background

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.