NCT05804162

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	Cagrilintide	Participants will receive 0.6 mg subcutaneous injections of cagrilintide once weekly and the dose will be then escalated once in 2 weeks for 8 weeks until the target maintenance dose of 4.5 mg is reached followed by a 38-day post-treatment period.
DRUG	Cagrilintide Placebo	Participants will receive cagrilintide placebo subcutaneously once weekly.
DRUG	Moxifloxacin	Partcipants will receive a single dose of moxifloxacin orally.
DRUG	Moxifloxacin Placebo	Partcipants will receive a single dose of moxifloxacin orally.

Timeline

• Start date: 2023-04-12
• Primary completion: 2023-08-12
• Completion: 2023-09-18
• First posted: 2023-04-07
• Last updated: 2024-11-01

Locations

1 site across 1 country: Germany