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Randomized Controlled Trial
. 2026 Feb 1;11(2):156-164.
doi: 10.1001/jamacardio.2025.4824.

Semaglutide and Hospitalizations in Patients With Obesity and Established Cardiovascular Disease: An Exploratory Analysis of the SELECT Randomized Clinical Trial

Stephen J Nicholls  1 , Donna H Ryan  2 , John Deanfield  3 , Daniel Ferreira  4 , Chim C Lang  5   6 , A Michael Lincoff  7 , Ildiko Lingvay  8 , Christopher Lübker  9 , Paula Pérez Terns  10 , Søren Rasmussen  9 , Signe Stensen  9 , Peter E Weeke  9 , Steven E Kahn  11 ; SELECT Trial Investigators
Collaborators, Affiliations
Randomized Controlled Trial

Semaglutide and Hospitalizations in Patients With Obesity and Established Cardiovascular Disease: An Exploratory Analysis of the SELECT Randomized Clinical Trial

Stephen J Nicholls et al. JAMA Cardiol. .

Abstract

Importance: The primary analysis of the SELECT randomized clinical trial suggests that semaglutide reduced the rates of cardiovascular (CV) death, myocardial infarction, and stroke in patients with established CV disease (CVD) and overweight or obesity without diabetes. However, the effect of semaglutide on hospitalizations in this population remains unknown.

Objective: To determine the impact of semaglutide on total hospital admissions and duration of hospital stay.

Design, setting, and participants: The SELECT trial included patients aged 45 years or older with established CVD and a body mass index (BMI, calculated as weight in kilograms divided by height in meters squared) of 27 or higher without diabetes at 804 clinical settings across North America, South America, Europe, Asia, Africa, and Australia. Patients were randomized from October 2018 to March 2021. This prespecified exploratory analysis was conducted from February 2024 to September 2025.

Interventions: Once-weekly subcutaneous semaglutide, 2.4 mg, or placebo.

Main outcomes and measures: The total number of hospital admissions and days in hospital between the semaglutide and placebo groups.

Results: A total of 17 604 patients (median [IQR] age, 61.0 [55.0-68.0] years; 4872 female patients [27.7%]; median [IQR] BMI, 32.1 [29.7-35.7]) were followed up for a median (IQR) period of 41.8 (33.0-47.0) months. There were 11 287 hospital admissions. The number of total hospitalizations was lower in the semaglutide group vs placebo for any indication (18.3 vs 20.4 admissions per 100 patient-years; mean ratio [MR], 0.90; 95% CI, 0.85-0.95; P < .001) and for serious adverse events (15.2 vs 17.1 admissions per 100 patient-years; MR, 0.89; 95% CI, 0.84-0.94; P < .001). The number of days hospitalized for any indication per 100 patient-years was lower in the semaglutide group vs placebo (157.2 vs 176.2 days; rate ratio [RR], 0.89; 95% CI, 0.82-0.98; P = .01), as well as hospitalizations for serious adverse events (137.6 vs 153.9 days; RR, 0.89; 95% CI, 0.81-0.98; P = .02). No heterogeneity was observed for the reduction of hospital admissions with semaglutide in selected subgroups, including BMI, age, and sex.

Conclusions and relevance: In this prespecified exploratory analysis of the SELECT randomized clinical trial, the trial cohort had a high rate of hospital admissions. Treatment with once-weekly semaglutide was associated with significant reductions in hospital admissions and overall time spent in hospital, extending its benefits beyond CV risk reduction.

Trial registration: ClinicalTrials.gov Identifier: NCT03574597.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Nicholls reported consulting fees paid to his institution from Novo Nordisk during the conduct of the study; grants paid to his institution from Amgen, Anthera, AstraZeneca, Cerenis Therapeutics, Cyclarity Therapeutics, Eli Lilly, Esperion, Infraredx, LipoScience, NewAmsterdam Pharma, Novartis, Resverlogix, Roche, Sanofi-Regeneron, and The Medicines Company; and consulting fees paid to his institution from Abcentra, Akcea Therapeutics, Amarin, Anthera Pharmaceuticals, AstraZeneca, Boehringer Ingelheim, CSL Behring, CSL Seqirus, Daiichi Sankyo, Eli Lilly, Esperion, Merck, Omthera Pharmaceuticals, Resverlogix, Sanofi-Regeneron, Scribe Therapeutics, Silence Therapeutics, Takeda, and Vaxxinity outside the submitted work. Dr Ryan reported personal fees from served on the Steering Committee for the SELECT trial from Novo Nordisk during the conduct of the study; holding stock options in Calibrate and Scientific Intake; and personal fees from AbbVie, Altimmune, Amgen, AstraZeneca, Biohaven, Boehringer Ingelheim, Carmo Therapeutics/Roche/Regeneron, CinRx Pharma, Currax Pharmaceuticals, eMed, Epitomee Medical, Fractyl Health, Gila Therapeutics, Lilly, Nestle, Novo Nordisk, Source Bio, Structure Therapeutics, Tenvie, Wondr Health, and Zealand Pharma outside the submitted work. Dr Deanfield reported grants from Alzheimer’s Research UK and the British Heart Foundation; consulting honoraria from Aegerion Pharmaceuticals, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Merck, Novartis, Novo Nordisk, Pfizer, and Sanofi; and serving as a member of the steering committees for the SOUL and SELECT trials outside the submitted work. Dr Lang reported grants from Novo Nordisk during the conduct of the study and grants from AstraZeneca, Boehringer Ingelheim, Moderna, and Roche Diagnostics outside the submitted work. Dr Lincoff reported Steering Committee fees from Novo Nordisk during the conduct of the study; consulting fees from Amgen and Eli Lilly; and research funding to institution from Esperion and Novartis outside the submitted work. Dr Lingvay reported funding for clinical trials to institution from Boehringer Ingelheim, Dexcom, Lilly, Novo Nordisk, Pfizer, and Roche; research-related consulting fees paid to institution from Novo Nordisk; and personal fees from AbbVie, Altimmune, Alveus Therapeutics, Amgen, Antag Therapeutics, AstraZeneca, Bain Capital, Bayer, Betagenon AB, Bioio Inc, Biomea, Boehringer Ingelheim, Boston Scientific, Carmot Therapeutics, Corxel, Cytoki Pharma, Eli Lilly, Genentech, Intercept, Janssen/Johnson & Johnson, Juvena Therapeutics, Keros Therapeutic Inc, Mediflix, Merck, Metsera, Neurocrine, Novo Nordisk, Pfizer, Regeneron, Roche, Sanofi, Shionogi, Skye Bioscience, Source Bio, Structure Therapeutics, Terns Pharma, The Comm Group, Verdiva Bio, WebMD, and Zealand Pharma outside the submitted work. Drs Lübker, Rasmussen, and Stensen reported being employees of and shareholders in Novo Nordisk A/S. Dr Weeke reported being an employee of Novo Nordisk . Dr Kahn reported personal fees from Novo Nordisk during the conduct of the study and personal fees from Amgen, Biomea Fusion, Eli Lilly, Merck, Neurimmune, and Oramed; and having stock options in AltPep outside the submitted work. No other disclosures were reported.

References

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    1. Colhoun HM, Lingvay I, Brown PM, et al. Long-term kidney outcomes of semaglutide in obesity and cardiovascular disease in the SELECT trial. Nat Med. 2024;30(7):2058-2066. doi: 10.1038/s41591-024-03015-5 - DOI - PMC - PubMed

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