Obesity
Conditions
Brief 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.
Interventions
DRUGCagrilintide
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.
Participants will receive cagrilintide placebo subcutaneously once weekly.
DRUGMoxifloxacin
Partcipants will receive a single dose of moxifloxacin orally.
DRUGMoxifloxacin Placebo
Partcipants will receive a single dose of moxifloxacin orally.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Sponsor staff involved in the clinical trial is masked according to company standard procedures
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Measured in millisecond |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Fridericia Heart Rate Corrected QT Interval (QTcF) at 2, 3 and 4 Hours Post-Dose of Moxifloxacin/Moxifloxacin Placebo | Pre-dose to 2, 3 and 4 hours post-dose on Day 2 and Day 55 | Measured in millisecond |
| 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 | From pre-last dose on Day 52 to 12, 24, 48 and 72 hours post-last dose on Day 55 | Measured in millisecond |
| 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 | From pre-last dose on Day 52 to 72 hours post-last dose on Day 55 | Measured as count of participants |
| 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 | From pre-last dose on Day 52 to 72 hours post-last dose on Day 55 | Measured as count of participants |
| Change from Baseline in QT Interval Corrected Individually for HR (QTcI) at 2, 3 and 4 Hours Post-Dose of Moxifloxacin/Moxifloxacin Placebo | Pre-dose to 2, 3 and 4 hours post-dose on Day 2 and Day 55 | Measured in millisecond |
Countries
Germany
Outcome results
None listed