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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05804162
• Other study ID #: NN9838-4672
• Secondary ID: U1111-1249-38342
• Status: Completed
• Phase: Phase 1
• Start date: April 12, 2023
• Est. completion date: September 18, 2023

Study information

• Verified date: October 2023
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: September 18, 2023
• Est. primary completion date: September 18, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Male or female.
• Aged 18-55 years (both inclusive) at the time of signing informed consent.
• Body mass index (BMI) between 23.0 and 29.9 kilogram per meter^2 (kg/m^2) (both inclusive) at screening.

Exclusion Criteria:

• Known or suspected hypersensitivity to trial products or related products, or to electrocardiogram (ECG) electrodes.
• Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method.
• History of seizures, epilepsy, repeated syncopes, cardiac arrest, cardiac arrhythmia or Torsades de Pointes (TdP), 2nd or 3rd degree atrioventricular (A-V) block or structural heart disease.
• Family history of long QT syndrome (either objectively diagnosed or suggested by sudden death due to cardiac causes before the age of 50 of a 1st degree relative).

Related Conditions & MeSH terms

• Obesity

Intervention

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.
• Cagrilintide Placebo
Participants will receive cagrilintide placebo subcutaneously once weekly.
• Moxifloxacin
Partcipants will receive a single dose of moxifloxacin orally.
• Moxifloxacin Placebo
Partcipants will receive a single dose of moxifloxacin orally.

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Measured in millisecond	From pre-last dose on Day 52 to 12, 24, 48 and 72 hours post-last dose on Day 55
Secondary	Change From Baseline in Fridericia Heart Rate Corrected QT Interval (QTcF) at 2, 3 and 4 Hours Post-Dose of Moxifloxacin/Moxifloxacin Placebo	Measured in millisecond	Pre-dose to 2, 3 and 4 hours post-dose on Day 2 and Day 55
Secondary	Change from Baseline in QT Interval Corrected Individually for HR (QTcI) at 12, 24, 48 and 72 Hours Post-Second Dose of Cagrilintide/Cagrilintide Placebo at the 4.5 mg Dose Level	Measured in millisecond	From pre-last dose on Day 52 to 12, 24, 48 and 72 hours post-last dose on Day 55
Secondary	Occurrence of Absolute QTcF Interval Prolongation: QTcF Interval > 450 millisecond (ms), QTcF Interval > 480 ms and QTcF Interval > 500 msB on ECG Recordings 0-72 Hours after Cagrilintide/Cagrilintide Placebo at the 4.5 mg Dose Levels	Measured as count of participants	From pre-last dose on Day 52 to 72 hours post-last dose on Day 55
Secondary	Occurrence of QTcF Interval Increases from Baseline > 30 ms and QTcF Interval Increases from Baseline > 60 ms Based on ECG Recordings 0-72 Hours after Cagrilintide/Cagrilintide Placebo at the 4.5 mg Dose Levels	Measured as count of participants	From pre-last dose on Day 52 to 72 hours post-last dose on Day 55
Secondary	Change from Baseline in QT Interval Corrected Individually for HR (QTcI) at 2, 3 and 4 Hours Post-Dose of Moxifloxacin/Moxifloxacin Placebo	Measured in millisecond	Pre-dose to 2, 3 and 4 hours post-dose on Day 2 and Day 55