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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-12

Study Completion Date

2023-09-18

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.

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Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Sponsor staff involved in the clinical trial is masked according to company standard procedures

Study Groups

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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.

Group Type EXPERIMENTAL

Cagrilintide

Intervention Type 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.

Moxifloxacin Placebo

Intervention Type DRUG

Partcipants will receive a single dose of moxifloxacin orally.

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.

Group Type ACTIVE_COMPARATOR

Cagrilintide Placebo

Intervention Type DRUG

Participants will receive cagrilintide placebo subcutaneously once weekly.

Moxifloxacin

Intervention Type DRUG

Partcipants will receive a single dose of moxifloxacin orally.

Moxifloxacin Placebo

Intervention Type DRUG

Partcipants will receive a single dose of moxifloxacin orally.

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.

Group Type ACTIVE_COMPARATOR

Cagrilintide Placebo

Intervention Type DRUG

Participants will receive cagrilintide placebo subcutaneously once weekly.

Moxifloxacin

Intervention Type DRUG

Partcipants will receive a single dose of moxifloxacin orally.

Moxifloxacin Placebo

Intervention Type DRUG

Partcipants will receive a single dose of moxifloxacin orally.

Interventions

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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.

Intervention Type DRUG

Cagrilintide Placebo

Participants will receive cagrilintide placebo subcutaneously once weekly.

Intervention Type DRUG

Moxifloxacin

Partcipants will receive a single dose of moxifloxacin orally.

Intervention Type DRUG

Moxifloxacin Placebo

Partcipants will receive a single dose of moxifloxacin orally.

Intervention Type DRUG

Other Intervention Names

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Cagrilintide A NNC0174-0833 A Cagrilintide A NNC0174-0833 A Moxifloxacinratiopharm

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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes