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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Obesity

Treatments: Drug: Cagrilintide Placebo; Drug: Cagrilintide; Drug: Moxifloxacin; Drug: Moxifloxacin Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05804162

U1111-1249-3834 (Other Identifier)

NN9838-4672

2022-002357-25 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 107 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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107 participants in 3 patient groups

Cagrilintide (Arm 1)

Experimental group

Description:

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.

Treatment:

Drug: Moxifloxacin Placebo

Drug: Cagrilintide

Cagrilintide Placebo (Arm 2A)

Active Comparator group

Description:

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.

Treatment:

Drug: Moxifloxacin Placebo

Drug: Moxifloxacin

Drug: Cagrilintide Placebo

Cagrilintide Placebo (Arm 2B)

Active Comparator group

Description:

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.

Treatment:

Drug: Moxifloxacin Placebo

Drug: Moxifloxacin

Drug: Cagrilintide Placebo