{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T18:49:18Z","timestamp":1790621358583,"version":"4.1.0"},"reference-count":24,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2024,9,16]],"date-time":"2024-09-16T00:00:00Z","timestamp":1726444800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["dom-pubs.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Diabetes Obesity Metabolism"],"published-print":{"date-parts":[[2024,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>The combination of cagrilintide and semaglutide (CagriSema) is being developed for the treatment of obesity and type 2 diabetes. The objective of this thorough QT study was to confirm that cagrilintide does not result in a clinically relevant prolongation in cardiac repolarization compared with placebo.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and Methods<\/jats:title>\n                    <jats:p>This was a double\u2010blind study (NCT05804162) in which healthy participants were randomized to cagrilintide, administered as a once\u2010weekly subcutaneous injection dose escalated to 4.5\u2009mg, or a placebo. The primary end point was the time\u2010matched change from baseline in Fridericia heart rate\u2013corrected QT interval (QTcF) at 12\u2010, 24\u2010, 48\u2010 and 72\u2009h after the last cagrilintide 4.5\u2010mg dose. To conclude that cagrilintide does not induce a clinically relevant prolongation, the upper limit of the two\u2010sided 90% confidence interval (CI) for the treatment difference at each of the four time points must fall below 10\u2009ms. To establish QT assay sensitivity, participants in the placebo arms received a single 400\u2010mg oral moxifloxacin dose as a positive control and moxifloxacin placebo in a nested cross\u2010over fashion.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      A total of 105 participants received cagrilintide (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200953) or placebo (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200952). No clinically relevant QTcF prolongation occurred after the last cagrilintide 4.5\u2010mg dose; the upper limits of the two\u2010sided 90% CIs of the placebo\u2010adjusted QTcF changes from baseline were below 10\u2009ms at all time points. QT assay sensitivity was demonstrated with moxifloxacin as a positive control.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Cagrilintide did not result in clinically relevant QTcF prolongation, indicating no increased risk of ventricular tachyarrhythmias.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/dom.15951","type":"journal-article","created":{"date-parts":[[2024,9,16]],"date-time":"2024-09-16T04:59:25Z","timestamp":1726462765000},"page":"5805-5811","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Cagrilintide is not associated with clinically relevant\n                    <scp>QTc<\/scp>\n                    prolongation: A thorough\n                    <scp>QT<\/scp>\n                    study in healthy participants"],"prefix":"10.1111","volume":"26","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2559-862X","authenticated-orcid":false,"given":"Maria B. N.","family":"Gabe","sequence":"first","affiliation":[{"name":"Novo Nordisk A\/S  S\u00f8borg Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rainard","family":"Fuhr","sequence":"additional","affiliation":[{"name":"Parexel International GmbH  Berlin Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Angela","family":"Sinn","sequence":"additional","affiliation":[{"name":"Parexel International GmbH  Berlin Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2261-0323","authenticated-orcid":false,"given":"Astrid","family":"Eliasen","sequence":"additional","affiliation":[{"name":"Novo Nordisk A\/S  S\u00f8borg Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kasper K.","family":"Berthelsen","sequence":"additional","affiliation":[{"name":"Novo Nordisk A\/S  S\u00f8borg Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8893-8498","authenticated-orcid":false,"given":"Anja B.","family":"Kuhlman","sequence":"additional","affiliation":[{"name":"Novo Nordisk A\/S  S\u00f8borg Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1348-0352","authenticated-orcid":false,"given":"Tine A.","family":"B\u00e6kdal","sequence":"additional","affiliation":[{"name":"Novo Nordisk A\/S  S\u00f8borg Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4688-7877","authenticated-orcid":false,"given":"Ayna B.","family":"Nejad","sequence":"additional","affiliation":[{"name":"Novo Nordisk A\/S  S\u00f8borg Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,9,16]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1093\/qjmed\/hcx152"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41366\u2010024\u201001473\u2010y"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.mcna.2017.08.012"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2023.19897"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1021\/acs.jmedchem.1c00565"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/s0899\u20109007(98)00044\u20106"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140\u20106736(21)00845\u2010X"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140\u20106736(21)01751\u20107"},{"key":"e_1_2_9_10_1","unstructured":"European Medicines Agency.Ozempic Summary of Product Characteristics.2018https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/ozempic#product-info"},{"key":"e_1_2_9_11_1","unstructured":"European Medicines Agency.Wegovy Summary of Product Characteristics.2022https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/wegovy#product-info"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1607141"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2307563"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140\u20106736(23)01163\u20107"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365\u20102125.2010.03660.x"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1136\/heart.89.11.1363"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2005.08.067"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1177\/2042098612454283"},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1520-765X(01)90009-4"},{"key":"e_1_2_9_20_1","unstructured":"The clinical evaluation of QT\/QTc interval.Prolongation and proarrhythmic potential for non\u2010antiarrhythmic drugs E14.2005https:\/\/www.ema.europa.eu\/en\/ich\u2010e14\u2010clinical\u2010evaluation\u2010qt\u2010qtc\u2010interval\u2010prolongation\u2010proarrhythmic\u2010potential\u2010non\u2010antiarrhythmic\u2010drugs\u2010scientific\u2010guideline"},{"key":"e_1_2_9_21_1","unstructured":"Guidance for industry.E14 clinical evaluation of QT\/QTc interval prolongation and proarrhythmic potential for non\u2010antiarrhythmic drugs. Food and Drug Administration (FDA) Docket Number: FDA\u20102004\u2010D\u20100241.2005."},{"key":"e_1_2_9_22_1","doi-asserted-by":"publisher","DOI":"10.1007\/s13300\u2010018\u20100442\u20100"},{"key":"e_1_2_9_23_1","doi-asserted-by":"publisher","DOI":"10.1080\/10543400903581945"},{"key":"e_1_2_9_24_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10928\u2010017\u20109558\u20105"},{"key":"e_1_2_9_25_1","doi-asserted-by":"publisher","DOI":"10.1038\/clpt.2008.33"}],"container-title":["Diabetes, Obesity and Metabolism"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/dom-pubs.pericles-prod.literatumonline.com\/doi\/pdf\/10.1111\/dom.15951","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,31]],"date-time":"2025-10-31T05:00:17Z","timestamp":1761886817000},"score":1,"resource":{"primary":{"URL":"https:\/\/dom-pubs.pericles-prod.literatumonline.com\/doi\/10.1111\/dom.15951"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,9,16]]},"references-count":24,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2024,12]]}},"alternative-id":["10.1111\/dom.15951"],"URL":"https:\/\/doi.org\/10.1111\/dom.15951","archive":["Portico"],"relation":{"has-review":[{"id-type":"doi","id":"10.1111\/DOM.15951\/v2\/review1","asserted-by":"object"},{"id-type":"doi","id":"10.1111\/DOM.15951\/v2\/response1","asserted-by":"object"},{"id-type":"doi","id":"10.1111\/DOM.15951\/v2\/decision1","asserted-by":"object"},{"id-type":"doi","id":"10.1111\/DOM.15951\/v1\/review1","asserted-by":"object"},{"id-type":"doi","id":"10.1111\/DOM.15951\/v1\/review2","asserted-by":"object"},{"id-type":"doi","id":"10.1111\/DOM.15951\/v1\/decision1","asserted-by":"object"}]},"ISSN":["1462-8902","1463-1326"],"issn-type":[{"value":"1462-8902","type":"print"},{"value":"1463-1326","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,9,16]]},"assertion":[{"value":"2024-07-30","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-08-29","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-09-16","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}