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

Study Overview
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Brief Summary
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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.

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

Conditions
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Obesity

Intervention / Treatment
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* Drug: Cagrilintide
* Drug: Cagrilintide Placebo
* Drug: Moxifloxacin
* Drug: Moxifloxacin Placebo


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cagrilintide (Arm 1)<br>Participants will receive 0.6 milligrams (mg) of cagrilintide subcutaneously 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. In addition, a single dose of moxifloxacin placebo prior to initiation of treatment and a single dose moxifloxacin placebo at the end of the treatment period will be administered orally. | Drug: Cagrilintide<br>* 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.<br>* Other names: NNC0174-0833 A;Drug: Moxifloxacin Placebo<br>* Partcipants will receive a single dose of moxifloxacin orally.<br>|
| Active Comparator: Cagrilintide Placebo (Arm 2A)<br>Participants will receive cagrilintide placebo subcutaenously once weekly. In addition, a single dose of moxifloxacin active prior to initiation of treatment and a single dose of moxifloxacin placebo at the end of the treatment period will be administered orally. | Drug: Cagrilintide Placebo<br>* Participants will receive cagrilintide placebo subcutaneously once weekly.<br>* Other names: NNC0174-0833 A;Drug: Moxifloxacin<br>* Partcipants will receive a single dose of moxifloxacin orally.<br>* Other names: Moxifloxacinratiopharm;Drug: Moxifloxacin Placebo<br>* Partcipants will receive a single dose of moxifloxacin orally.<br>|
| Active Comparator: Cagrilintide Placebo (Arm 2B)<br>Participants will receive cagrilintide placebo subcutaneously once weekly. In addition, a single dose of moxifloxacin placebo prior to initiation of treatment and a single dose of moxifloxacin active at the end of the treatment period will be administered orally. | Drug: Cagrilintide Placebo<br>* Participants will receive cagrilintide placebo subcutaneously once weekly.<br>* Other names: NNC0174-0833 A;Drug: Moxifloxacin<br>* Partcipants will receive a single dose of moxifloxacin orally.<br>* Other names: Moxifloxacinratiopharm;Drug: Moxifloxacin Placebo<br>* Partcipants will receive a single dose of moxifloxacin orally.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |