A Research Study Looking at How Cagrilintide Works on the Heart Rhythm in Healthy Participants

Phase 1 Completed 107 enrolled Novo Nordisk A/S

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The study tests if treatment with cagrilintide delays the transmission of electrical signals in the heart compared to treatment with placebo. To confirm the sensitivity of the methodology, the drug moxifloxacin is also compared to a placebo in 2 treatment arms. Cagrilintide is being developed for the treatment of obesity and weight management. Moxifloxacin is an approved antibiotic for the treatment of bacterial illnesses. The study lasts for up to 17 weeks for each participant.

Timeline

Start: 2023-04-12
Primary completion: 2023-08-12
Completion: 2023-09-18

Outcome

Met primary endpoint

paper 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. PMID 39279639 ↗

Publications

Results Gabe MBN, Fuhr R, Sinn A, Eliasen A, Berthelsen KK, Kuhlman AB, Baekdal TA, Nejad AB. Cagrilintide is not associated with clinically relevant QTc prolongation: A thorough QT study in healthy participants. Diabetes Obes Metab. 2024 Dec;26(12):5805-5811. doi: 10.1111/dom.15951. Epub 2024 Sep 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cagrilintide	Protein / enzyme biologic	4.5 mg	Subcutaneous
Comparator	Moxifloxacin	Small molecule	400 mg	Oral