{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,11]],"date-time":"2026-03-11T14:04:37Z","timestamp":1773237877130,"version":"3.50.1"},"reference-count":20,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2023,1,20]],"date-time":"2023-01-20T00:00:00Z","timestamp":1674172800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["The Journal of Clinical Pharma"],"published-print":{"date-parts":[[2023,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Although estimates of the prevalence of cardiac arrhythmias in healthy volunteers exist, there is a lack of baseline data in other specific populations, such as people living with overweight and obesity, who are increasingly involved in clinical trials. This study investigated the baseline prevalence of arrhythmias in participants with overweight or obesity in 2 phase 1 trials of weight management medications (NCT03661879, NCT03308721). Participants aged 18\u201355 years, without a history of cardiovascular disease, and with body mass index (BMI) of 25.0\u201339.9\u00a0kg\/m<jats:sup>2<\/jats:sup>, were screened for abnormalities in vital signs, electrocardiogram (ECG) recordings, and electrolytes. Baseline 24\u2010hour ECG (Holter) data were collected and manually reviewed by a cardiologist. The primary endpoint was the proportion of participants with \u22651 episode of the predefined cardiac arrhythmias. Continuous 12\u2010lead ECG data were obtained from 207 participants. Most arrhythmias occurred in &lt;3% of participants. Atrioventricular blocks and other potentially malignant arrhythmias were uncommon. There were no associations with age, sex, or BMI. Prevalence of atrioventricular blocks, nonsustained ventricular tachycardia, and other potentially malignant arrhythmias mirrored those reported in healthy participants with normal weight. In clinical trials of weight management medication, knowledge of the baseline prevalence of arrhythmias in people with overweight and obesity may inform trial eligibility criteria, improve on\u2010trial decisions, and could be useful in discussions with health authorities. Baseline Holter readings and real\u2010time ECG telemetry monitoring should be considered in such trials if arrhythmia risk is intrinsic to the molecule, or when signals have been observed in preclinical studies.<\/jats:p>","DOI":"10.1002\/jcph.2193","type":"journal-article","created":{"date-parts":[[2022,12,16]],"date-time":"2022-12-16T10:46:50Z","timestamp":1671187610000},"page":"539-543","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Prevalence of Baseline Cardiac Arrhythmias in Participants with Overweight or Obesity in Phase 1 Clinical Trials: Analysis of 24\u2010Hour Holter Electrocardiogram Recordings"],"prefix":"10.1002","volume":"63","author":[{"given":"Dorthe","family":"Skovgaard","sequence":"first","affiliation":[{"name":"Novo Nordisk A\/S S\u00f8borg Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Poul\u2010Martin","family":"Haahr","sequence":"additional","affiliation":[{"name":"Novo Nordisk A\/S S\u00f8borg Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robert","family":"Lester","sequence":"additional","affiliation":[{"name":"Celerion Tempe Arizona USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Katherine","family":"Clark","sequence":"additional","affiliation":[{"name":"Celerion Tempe Arizona USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sabina","family":"Paglialunga","sequence":"additional","affiliation":[{"name":"Celerion Tempe Arizona USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nick","family":"Finer","sequence":"additional","affiliation":[{"name":"Novo Nordisk A\/S S\u00f8borg Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Martin H.","family":"Friedrichsen","sequence":"additional","affiliation":[{"name":"Novo Nordisk A\/S S\u00f8borg Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Julie B.","family":"Hjerpsted","sequence":"additional","affiliation":[{"name":"Novo Nordisk A\/S M\u00e5lev Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mads D.M.","family":"Engelmann","sequence":"additional","affiliation":[{"name":"Novo Nordisk A\/S S\u00f8borg Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2023,1,20]]},"reference":[{"key":"e_1_2_11_2_1","unstructured":"U.S. Food and Drug Administration.Guidance for industry: E14 clinical evaluation of QT\/QTc interval prolongation and proarrhythmic potential for non\u2010antiarrhythmic drugs.https:\/\/www.fda.gov\/media\/71372\/download. Published October2005. Accessed December 20 2021."},{"key":"e_1_2_11_3_1","first-page":"22","article-title":"Cardiac safety investigations 10 years after ICH guidance E14: evolving industry and regulatory viewpoints on evaluation of proarrhythmic risk during new drug development","volume":"7","author":"Kothari S","year":"2015","journal-title":"J Clin Stud"},{"key":"e_1_2_11_4_1","unstructured":"European Medicines Agency.ICH guideline E14: the clinical evaluation of QT\/QTc interval prolongation and proarrhythmic potential for non\u2010antiarrhythmic drugs (R3) \u2010 questions and answers.https:\/\/www.ema.europa.eu\/en\/documents\/scientific\u2010guideline\/ich\u2010guideline\u2010e14\u2010clinical\u2010evaluation\u2010qt\/qtc\u2010interval\u2010prolongation\u2010proarrhythmic\u2010potential\u2010non\u2010antiarrhythmic\u2010drugs\u2010r3\u2010questions\u2010answers\u2010step_en.pdf. Published January 25 2016. 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