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. 2025 May;51(3):101625.
doi: 10.1016/j.diabet.2025.101625. Epub 2025 Feb 17.

Semaglutide 2.4 mg in French people living with Class 3 obesity and comorbidities: Baseline characteristics and real-world safety data

Emmanuel Disse  1 , Judith Aron-Wisnewsky  2 , David Jacobi  3 , Karine Clément  2 , Martine Laville  4 , Cyril Gauthier  5 , François Pattou  6 , Julie Molleville  7 , Melissa Akerib  8 , Lysiane Jubin  9 , Blandine Gatta-Cherifi  10 , Bénédicte Gaborit  11 , Emilie Montastier  12 , Fabien Stenard  13 , Claire Carette  14 , Najate Achamrah  15 , Antoine Avignon  16 , Sébastien Czernichow  9 ; SEMAFEAP Study Group
Collaborators, Affiliations

Semaglutide 2.4 mg in French people living with Class 3 obesity and comorbidities: Baseline characteristics and real-world safety data

Emmanuel Disse et al. Diabetes Metab. 2025 May.

Abstract

Aim: - To describe baseline characteristics and safety data of real-world use of semaglutide 2.4 mg.

Methods: - Patients with a body mass index (BMI) ≥40 kg/m2 and at least one of the following treated weight-related comorbidities (WRC: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease) were eligible to receive treatment through Temporary Utilization Authorization (TUA: March to June 2022) or Early Access Program (EAP: July 2022 to October 2023). Data were collected according to Health Authorities' requirements. Only descriptive statistics were used.

Results: - Overall, 5,797 (62.8%) treatment requests were sent by sites specialized in obesity management. In total, 478 and 8,568 patients were treated within TUA and EAP cohorts respectively, with mean follow-up durations of 1.2 and 4.5 months, respectively. Mean (SD) BMI was 48.9 (9.7) and 47.0 (7.4) kg/m2, respectively. Age ranged from 18 to 81 years. In the EAP, 57.4%, 26.5%, 12.3% and 3.7% of patients had 1, 2, 3 and 4 WRC. In addition, 15.5% had type 2 diabetes, 18.1% reported depression and 15.4% had osteoarthritis. In the EAP, 247 (2.9%) patients discontinued treatment after a median time of 2.8 months (IQR: 1.2-5.1), mainly due to adverse events (AEs) (47.0%). During TUA, 3 patients discontinued due to AEs. Pancreatitis was reported in 7 cases overall.

Conclusion: - The high number of treatment prescriptions in a short period highlights the high unmet medical need. No new safety concerns were identified in this population with severe obesity treated in a real-world setting.

Keywords: Early access; Obesity; Real-world data; Safety; Semaglutide.

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Conflict of interest statement

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Emmanuel Disse has received consulting and/or lecturing fees from Lilly, Sanofi, Rhythm Pharmaceuticals, Novo Nordisk, AstraZeneca, Boehringer, Amryt, Pfizer and Medtronic outside the current manuscript. He was also an investigator of the STEP 1, STEP 9, REDEFINE 1 & REDEFINE 9 trials. Sebastien Czernichow has received consulting and/or lecturing fees from Lilly, Fresenius, Novartis, Novo Nordisk, BMS, Boehringer, Pfizer and Bariatek outside the current manuscript. He was also an investigator of the STEP 1 & STEP 9 trials. Judith Aron-Wisnewsky has no disclosure to declare David Jacobi has received consulting and/or lecturing fees from Lilly, Novo Nordisk, Pfizer, and Amgen outside the current manuscript. Karine Clement's research group has received research funds from Rhythm pharmaceutical, outside the current manuscript. Martine Laville has received consulting and/or lecturing fees from Lilly, Novo Nordisk, Pfizer, outside the current manuscript. Cyril Gauthier has received consulting and/or lecturing fees from Novo Nordisk outside the current manuscript. François Pattou has received consulting and/or lecturing fees from Novo Nordisk outside the current manuscript. Julie Molleville has received consulting and/or lecturing fees from Novo Nordisk, outside the current manuscript. Melissa Akerib is an employee at Novo Nordisk. Lysiane Jubin was an employee at Novo Nordisk at the time of the Early access program and current manuscript. Blandine Gatta-Cherifi has received consulting and/or lecturing fees from Rhythm pharmaceutical and Novo Nordisk outside the current manuscript Benedicte Gaborit has received consulting and/or lecturing fees from Lilly, Boehringer Ingelheim, Sanofi, Pfizer, Novo Nordisk outside the current manuscript Emilie Montastier has received consulting and/or lecturing fees from Amgen, Rhythm pharmaceutical and Lilly outside the current manuscript. Fabien Stenard has received consulting fees from Novo Nordisk outside the current manuscript. Claire Carette has received consulting and/or lecturing fees from Novo Nordisk, Lilly, Boehringer Ingelheim, Sanofi, Pfizer, Rhythm, Bioproject Pharma, Novartis, MSD and Astra Zeneca outside the current manuscript. Najate Achamrah has no disclosures. Antoine Avignon has received consulting and/or lecturing fees from Novo Nordisk outside the current manuscript.

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