## Protocol Section
### Identification Module
**NCT ID:** NCT06426446

**Acronym:** TELE-SEMA

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

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

#### Organization Study ID Info
**ID:** APHP230587
#### Organization
**Class:** OTHER
**Full Name:** Assistance Publique - Hôpitaux de Paris
### Status Module
#### Completion Date
**Date:** 2025-06-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-06-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** BPIfrance

**Class:** INDUSTRY

**Name:** Withings

#### Lead Sponsor

**Class:** OTHER

**Name:** Assistance Publique - Hôpitaux de Paris

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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®.

**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 Module

**Conditions:**

- Obesity

**Keywords:**

- Obesity

- Wegovy

- Semaglutide 2.4 mg/week

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** HEALTH_SERVICES_RESEARCH

#### Enrollment Info

**Count:** 80

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients receiving connected scale

**Intervention Names:**

- Device: Withings Body Comp Pro

**Label:** Connected scale

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Connected scale

**Description:** 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)

**Name:** Withings Body Comp Pro

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Body weight measured at month 0 and 6

**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

#### Secondary Outcomes

**Description:** Body weight measured weekly

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

**Time Frame:** 6 months

**Description:** Body composition measured weekly

**Measure:** 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

**Description:** Pulse wave velocity

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

**Time Frame:** 6 months

**Description:** Arterial stiffness

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

**Time Frame:** 6 months

**Description:** Vascular age

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

**Time Frame:** 6 months

**Description:** Heart rate

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

**Time Frame:** 6 months

**Description:** Nervous system health measured weekly

**Measure:** 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

**Description:** Pulse wave velocity at month 0 and 6

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

**Time Frame:** 6 months

**Description:** Arterial stiffness at month 0 and 6

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

**Time Frame:** 6 months

**Description:** Vascular age at month 0 and 6

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

**Time Frame:** 6 months

**Description:** Heart rate at month 0 and 6

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

**Time Frame:** 6 months

**Description:** Eating behavior at month 0 and 6

**Measure:** 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

**Description:** Level of physical activity at month 0 and 6

**Measure:** 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

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

**Measure:** 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

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** josephine.braun@aphp.fr

**Name:** Josephine BRAUN

**Phone:** 01 44 84 17 38

**Role:** CONTACT

**Contact 2:**

**Email:** liliane.berkani@aphp.fr

**Name:** Liliane HAMMANI-BERKANI

**Phone:** 01 56 09 37 62

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Paris

**Contacts:**

***Contact 1:***

- **Email:** sebastien.czernichow@aphp.fr

- **Name:** Sébastien Czernichow, MD, PhD

- **Role:** CONTACT

***Contact 2:***

- **Email:** nathalie.alrassy@aphp.fr

- **Name:** Nathalie Alrassy, PhD

- **Role:** CONTACT

**Country:** France

**Facility:** Hôpital européen Georges Pompidou - APHP

**Zip:** 75015

#### Overall Officials

**Official 1:**

**Affiliation:** Assistance Publique - Hôpitaux de Paris

**Name:** Sébastien Czernichow, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**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)

**Description:** Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

**Info Types:**

- STUDY_PROTOCOL

- ICF

**IPD Sharing:** YES

**Time Frame:** Two years after the last publication

### References Module

#### References

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**PMID:** 34238998

**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.

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**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

**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.

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**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.

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**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.

**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.

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**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.

**PMID:** 32213703

**Citation:** 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.

**PMID:** 36655300

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**PMID:** 32814459

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000050177

- Term: Overweight

- ID: D000044343

- Term: Overnutrition

- ID: D000009748

- Term: Nutrition Disorders

- ID: D000001835

- Term: Body Weight

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12701

- Name: Obesity

- Relevance: HIGH

- As Found: Obesity

- ID: M12702

- Name: Obesity, Morbid

- Relevance: HIGH

- As Found: Severe Obesity

- ID: M26186

- Name: Overweight

- Relevance: LOW

- As Found: Unknown

- ID: M25307

- Name: Overnutrition

- Relevance: LOW

- As Found: Unknown

- ID: M12684

- Name: Nutrition Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5114

- Name: Body Weight

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009765

- Term: Obesity

- ID: D000009767

- Term: Obesity, Morbid

### Intervention Browse Module - Browse Branches

- Abbrev: Hypo

- Name: Hypoglycemic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M353561

- Name: Semaglutide

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
