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Cagrilintide is not associated with clinically relevant QTc prolongation: A thorough QT study in healthy participants.
Gabe, Maria B N; Fuhr, Rainard; Sinn, Angela; Eliasen, Astrid; Berthelsen, Kasper K; Kuhlman, Anja B; Bækdal, Tine A; Nejad, Ayna B.
Afiliación
  • Gabe MBN; Novo Nordisk A/S, Søborg, Denmark.
  • Fuhr R; Parexel International GmbH, Berlin, Germany.
  • Sinn A; Parexel International GmbH, Berlin, Germany.
  • Eliasen A; Novo Nordisk A/S, Søborg, Denmark.
  • Berthelsen KK; Novo Nordisk A/S, Søborg, Denmark.
  • Kuhlman AB; Novo Nordisk A/S, Søborg, Denmark.
  • Bækdal TA; Novo Nordisk A/S, Søborg, Denmark.
  • Nejad AB; Novo Nordisk A/S, Søborg, Denmark.
Diabetes Obes Metab ; 2024 Sep 16.
Article en En | MEDLINE | ID: mdl-39279639
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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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Diabetes Obes Metab Asunto de la revista: ENDOCRINOLOGIA / METABOLISMO Año: 2024 Tipo del documento: Article País de afiliación: Dinamarca Pais de publicación: Reino Unido
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Diabetes Obes Metab Asunto de la revista: ENDOCRINOLOGIA / METABOLISMO Año: 2024 Tipo del documento: Article País de afiliación: Dinamarca Pais de publicación: Reino Unido