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Trial · Interventional

CompletedPhase 1Registry data

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

NCTNCT05804162 (opens ClinicalTrials.gov in a new tab)Other idNN9838-4672Other idU1111-1249-3834Other id2022-002357-25
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
107 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Quadruple masking
Countries
1 country

Germany

Start
12 Apr 2023
Primary completion
12 Aug 2023
Completion
18 Sept 2023
First posted
7 Apr 2023
Last update posted
1 Nov 2024
Conditions
Obesity

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20232024
  1. Ph 1

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

    NCT05804162

    12 Apr 2023 to 18 Sept 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

  • CagrilintideDrug
  • Cagrilintide PlaceboDrug
  • MoxifloxacinDrug
  • Moxifloxacin PlaceboDrug

Arms3

  • Experimental

    Cagrilintide (Arm 1)

    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.

  • Active comparator

    Cagrilintide Placebo (Arm 2A)

    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.

  • Active comparator

    Cagrilintide Placebo (Arm 2B)

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  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

    Registry description

    Measured in millisecond

Secondary outcomes(5)

  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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    Measured in millisecond

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2024

1 result

Cagrilintide is not associated with clinically relevant QTc prolongation: A thorough QT study in healthy participants.

Gabe et al. 2024Diabetes, obesity & metabolismcited by 2

PMID 39279639DOI 10.1111/dom.15951PUB-39279639

Full text at the publisher1 result
Publisher pageSee results (1)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 55 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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).

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