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

• Status: Not yet recruiting
• Trial end date: 2024-03-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

Criteria

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).