Status
Completed
Phase
Phase 1
Enrollment
107
Locations
1
Results
Not posted
Publications
1
Study 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
DRUG
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
Participants will receive cagrilintide placebo subcutaneously once weekly.
DRUG
Partcipants will receive a single dose of moxifloxacin orally.
DRUG
Partcipants will receive a single dose of moxifloxacin orally.
Timeline
First posted
Apr 7, 2023
Study start
Apr 12, 2023
Primary completion
Aug 12, 2023
Study completion
Sep 18, 2023
Results posted
Not reported
Registry updated
Nov 1, 2024
Outcomes
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
Time frame · From pre-last dose on Day 52 to 12, 24, 48 and 72 hours post-last dose on Day 55
Measured in millisecond
Change From Baseline in Fridericia Heart Rate Corrected QT Interval (QTcF) at 2, 3 and 4 Hours Post-Dose of Moxifloxacin/Moxifloxacin Placebo
Time frame · 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
Time frame · 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
Time frame · 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
Time frame · 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
Time frame · Pre-dose to 2, 3 and 4 hours post-dose on Day 2 and Day 55
Measured in millisecond
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).
Study locations
Germany. Showing up to 24 locations stored in the fast local snapshot.
Parexel International GmbH
Berlin, Germany
Publications
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