Study S002210

A Thorough QTc Study Evaluating the Effect of Cagrilintide on Cardiac Repolarisation in Healthy Participants

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

ClinicalTrials.gov record

Registration

Registration: NCT05804162
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 107
Start: 2023-04-12
Primary completion: 2023-08-12
Lead sponsor: Novo Nordisk A/S
Conditions: Obesity
Interventions: DRUG:Cagrilintide; DRUG:Cagrilintide Placebo; DRUG:Moxifloxacin; DRUG:Moxifloxacin Placebo
Results posted: FALSE
Individual participant data sharing: YES
Secondary identifiers: OTHER:U1111-1249-3834; EUDRACT_NUMBER:2022-002357-25

Registered primary outcomes

Change From Baseline in Fridericia Heart Rate Corrected QT Interval (QTcF) At 12, 24, 48 and 72 Hours Post-Second Dose of Cagrilintide/Cagrilintide Placebo at the 4.5 mg Dose Level [From pre-last dose on Day 52 to 12, 24, 48 and 72 hours post-last dose on Day 55]

Linked records (1)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0010504	Cagrilintide is not associated with clinically relevant QTc prolongation: A thorough QT study in healthy participants. Gabe MBN, Diabetes, obesity & metabolism	2024	Randomized trial	PMID 39279639 DOI	cites ClinicalTrials.gov:NCT05804162; registry reference RESULT:39279639