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Completed

NCT Number: NCT05804162

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Parexel International GmbH

Berlin, 14050, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Cagrilintide

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.

Other names: Cagrilintide A, NNC0174-0833 A

Cagrilintide Placebo

Drug

Participants will receive cagrilintide placebo subcutaneously once weekly.

Other names: Cagrilintide A, NNC0174-0833 A

moxifloxacin

Drug

Partcipants will receive a single dose of moxifloxacin orally.

Other names: Moxifloxacinratiopharm

Moxifloxacin Placebo

Drug

Partcipants will receive a single dose of moxifloxacin orally.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 7, 2023
Registry last updated
Nov 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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