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

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05804162
Collaborator
(none)
100
Enrollment
1
Location
3
Arms
11.5
Anticipated Duration (Months)
8.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Sponsor staff involved in the clinical trial is masked according to company standard procedures
Primary Purpose:
Treatment
Official Title:
A Thorough QTc Study Evaluating the Effect of Cagrilintide on Cardiac Repolarisation in Healthy Participants
Anticipated Study Start Date :
Mar 27, 2023
Anticipated Primary Completion Date :
Mar 10, 2024
Anticipated Study Completion Date :
Mar 10, 2024

Arms and Interventions

Arm Intervention/Treatment
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.

Drug: Cagrilintide
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

    • Drug: Moxifloxacin Placebo
    Partcipants will receive a single dose of moxifloxacin 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.

    Drug: Cagrilintide Placebo
    Participants will receive cagrilintide placebo subcutaneously once weekly.
    Other Names:
  • Cagrilintide A
  • NNC0174-0833 A

    • Drug: Moxifloxacin
    Partcipants will receive a single dose of moxifloxacin orally.
    Other Names:
  • Moxifloxacinratiopharm

    • Drug: Moxifloxacin Placebo
    Partcipants will receive a single dose of moxifloxacin 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.

    Drug: Cagrilintide Placebo
    Participants will receive cagrilintide placebo subcutaneously once weekly.
    Other Names:
  • Cagrilintide A
  • NNC0174-0833 A

    • Drug: Moxifloxacin
    Partcipants will receive a single dose of moxifloxacin orally.
    Other Names:
  • Moxifloxacinratiopharm

    • Drug: Moxifloxacin Placebo
    Partcipants will receive a single dose of moxifloxacin orally.

    Outcome Measures

    Primary Outcome Measures

    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 [From pre-last dose on Day 52 to 12, 24, 48 and 72 hours post-last dose on Day 55]

      Measured in millisecond

    Secondary Outcome Measures

    1. 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

    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 [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 [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 [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 [Pre-dose to 2, 3 and 4 hours post-dose on Day 2 and Day 55]

      Measured in millisecond

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts 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 meter2 (kg/m2) (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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novo Nordisk Investigational Site Berlin Germany 14050

    Sponsors and Collaborators

    • Novo Nordisk A/S

    Investigators

    • Study Director: Clinical Transparency Dept. 2834, Novo Nordisk A/S

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novo Nordisk A/S
    ClinicalTrials.gov Identifier:
    NCT05804162
    Other Study ID Numbers:
    • NN9838-4672
    • U1111-1249-3834
    • 2022-002357-25
    First Posted:
    Apr 7, 2023
    Last Update Posted:
    Apr 7, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Moxifloxacin
    Norgestimate, ethinyl estradiol drug combination

    Study Results

    No Results Posted as of Apr 7, 2023