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Diabetes Obesity and Metabolism
Article . 2024 . Peer-reviewed
License: CC BY NC
Data sources: Crossref
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Cagrilintide is not associated with clinically relevant QTc prolongation: A thorough QT study in healthy participants

Authors: Maria B. N. Gabe; Rainard Fuhr; Angela Sinn; Astrid Eliasen; Kasper K. Berthelsen; Anja B. Kuhlman; Tine A. Bækdal; +1 Authors

Cagrilintide is not associated with clinically relevant QTc prolongation: A thorough QT study in healthy participants

Abstract

Abstract 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 assay 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.

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Keywords

Adult, Male, Moxifloxacin, Glucagon-Like Peptides, Semaglutide, Middle Aged, Healthy Volunteers, Islet Amyloid Polypeptide, Young Adult, Electrocardiography, Long QT Syndrome, Diabetes Mellitus, Type 2, Double-Blind Method, Heart Rate, Humans, Hypoglycemic Agents, Female

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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
2
Top 10%
Average
Average
hybrid