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

Obesity Clinical Trial

— TELE-SEMA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06426446
• Other study ID #: APHP230587
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: June 1, 2025

Study information

• Verified date: April 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Josephine BRAUN
• Phone: 01 44 84 17 38
• Email: josephine.braun[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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®.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Obesity, Morbid

Intervention

Device:
• Withings Body Comp Pro
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)

Locations

Country	Name	City	State
France	Hôpital européen Georges Pompidou - APHP	Paris

Sponsors (3)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	BPIfrance, Withings

Country where clinical trial is conducted

France, 

References & Publications (20)

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

Beleigoli AM, Andrade AQ, Cancado AG, Paulo MN, Diniz MFH, Ribeiro AL. Web-Based Digital Health Interventions for Weight Loss and Lifestyle Habit Changes in Overweight and Obese Adults: Systematic Review and Meta-Analysis. J Med Internet Res. 2019 Jan 8;21(1):e298. doi: 10.2196/jmir.9609. — View Citation

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.

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. — View Citation

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. Erratum In: Diabetes Ther. 2022 Jun;13(6):1251. — View Citation

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. — View Citation

Garcia de Lucas MD, Miramontes-Gonzalez JP, Aviles-Bueno B, Jimenez-Millan AI, Rivas-Ruiz F, Perez-Belmonte LM. Real-world use of once-weekly semaglutide in patients with type 2 diabetes at an outpatient clinic in Spain. Front Endocrinol (Lausanne). 2022 Sep 16;13:995646. doi: 10.3389/fendo.2022.995646. eCollection 2022. — View Citation

Garcia-Ulloa AC, Almeda-Valdes P, Aguilar-Salinas CA, Hernandez-Jimenez S; Group of Study CAIPaDi. 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. J Diabetes Sci Technol. 2021 Mar;15(2):525-527. doi: 10.1177/1932296820949941. Epub 2020 Aug 19. No abstract available. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

Stewart T, Han H, Allen RH, Bathalon G, Ryan DH, Newton RL Jr, Williamson DA. H.E.A.L.T.H.: efficacy of an internet/population-based behavioral weight management program for the U.S. Army. J Diabetes Sci Technol. 2011 Jan 1;5(1):178-87. doi: 10.1177/193229681100500125. — View Citation

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. — View Citation

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.

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. — View Citation

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. — View Citation

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.

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

Yale JF, Bodholdt U, Catarig AM, Catrina S, Clark A, Ekberg NR, Erhan U, Holmes P, Knudsen ST, Liutkus J, Sathyapalan T, Schultes B, Rudofsky G. 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 Res Care. 2022 Apr;10(2):e002619. doi: 10.1136/bmjdrc-2021-002619. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The variation of body weight measured by the connected scale between participants receiving semaglutide at the maximum tolerated dose	Body weight measured weekly	6 months
Secondary	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	6 months
Secondary	The variation of pulse wave velocity measured by the connected scale between participants receiving semaglutide at the maximum tolerated dose	Pulse wave velocity	6 months
Secondary	The variation of arterial stiffness measured by the connected scale between participants receiving semaglutide at the maximum tolerated dose	Arterial stiffness	6 months
Secondary	The variation of vascular age measured by the connected scale between participants receiving semaglutide at the maximum tolerated dose	Vascular age	6 months
Secondary	The variation of heart rate measured by the connected scale between participants receiving semaglutide at the maximum tolerated dose	Heart rate	6 months
Secondary	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	6 months
Secondary	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	6 months
Secondary	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	6 months
Secondary	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	6 months
Secondary	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	6 months
Secondary	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	6 months
Secondary	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	6 months
Secondary	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	6 months