Cagrilintide is not associated with clinically relevant QTc prolongation: A thorough QT study in healthy participants
Authors' conclusion
Cagrilintide did not result in clinically relevant QTcF prolongation, indicating no increased risk of ventricular tachyarrhythmias.
Study context
- Population
- Healthy participants
- Participants
- 105 participants
- Comparison
- Once-weekly SC cagrilintide vs placebo
- Cagrilintiden = 53
- Placebon = 52reference
- Primary endpoint
- Time-matched change from baseline in QTcF; no clinically relevant prolongation if upper limit of two-sided 90% CI for treatment difference <10 ms at each time point
- Follow-up
- 12, 24, 48 and 72 h after last cagrilintide 4.5-mg dose
Methodological detailsthorough QT study, double-blind, placebo-controlled, nested cross-over moxifloxacin positive control
- Thorough QT study
- Double-blind
- Placebo-controlled
- Nested cross-over moxifloxacin positive control
Primary result
As reported in the abstract
Placebo-adjusted QTcF change from baseline · 12, 24, 48 and 72 h after last 4.5-mg dose
- No clinically relevant QTcF prolongation; upper limits of two-sided 90% CIs of placebo-adjusted QTcF changes from baseline were below 10 ms at all time points
Further findings
- QT assay sensitivity demonstrated with moxifloxacin as positive control
Original publication
Cagrilintide is not associated with clinically relevant QTc prolongation: A thorough QT study in healthy participants. Diabetes Obes Metab. Published 16 September 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →