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Cagrilintide is not associated with clinically relevant QTc prolongation: A thorough QT study in healthy participants
Aims: 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. Materials and
Methods: This was a double-blind study (NCT05804162) in which healthy participants were randomized to cagrilintide, administered as a once-weekly subcutaneous injection dose escalated to 4.5 mg, or a placebo. The primary end point was the time-matched change from baseline in Fridericia heart rate–corrected QT interval (QTcF) at 12-, 24-, 48- and 72 h after the last cagrilintide 4.5-mg dose. To conclude that cagrilintide does not induce a clinically relevant prolongation, the upper limit of the two-sided 90% confidence interval (CI) for the treatment difference at each of the four time points must fall below 10 ms. To establish QT a ssay sensitivity, participants in the placebo arms received a single 400-mg oral moxifloxacin dose as a positive control and moxifloxacin placebo in a nested cross-over fashion.
Results: A total of 105 participants received cagrilintide (n = 53) or placebo (n = 52). No clinically relevant QTcF prolongation occurred after the last cagrilintide 4.5-mg dose; the upper limits of the two-sided 90% CIs of the placebo-adjusted QTcF changes from baseline were below 10 ms at all time points. QT assay sensitivity was demonstrated with moxifloxacin as a positive control. Conclusions: Cagrilintide did not result in clinically relevant QTcF prolongation, indicating no increased risk of ventricular tachyarrhythmias. © 2024 The Author(s). Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.
Authors : Gabe M.B.N.; Fuhr R.; Sinn A.; Eliasen A.; Berthelsen K.K.; Kuhlman A.B.; Bækdal T.A.; Nejad A.B.
Source : John Wiley and Sons Inc
Article Information
| Year | 2024 |
| Type | Article |
| DOI | 10.1111/dom.15951 |
| ISSN | 14628902 |
| Volume | 26 |
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