A Thorough QTc Evaluation of the Effect of Semaglutide on Cardiac Repolarisation in Healthy Subjects

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy; Diabetes

Treatments: Drug: placebo; Drug: moxifloxacin; Drug: semaglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT02064348

2012-005073-31 (EudraCT Number)

U1111-1136-6455 (Other Identifier)

NN9535-3652

Details and patient eligibility

About

This trial is conducted in Europe. The aim of the trial is to evaluate the effect of semaglutide on cardiac repolarisation in healthy subjects.

Enrollment: 168 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• BMI (Body Mass Index): 20-30 kg/m^2
• Body weight: 60-110 kg
• Normal ECG (electrocardiogram)

Exclusion criteria

• Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method. Women of child-bearing potential must use an effective method of birth control for the duration of the trial and for 5 weeks following the last dose of semaglutide. Only highly effective methods of birth control are accepted (i.e. one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices), or sexual abstinence or vasectomised partner
• Any clinically significant disease history, in the opinion of the investigator, or systemic or organ
• History of seizures, epilepsy, syncope, cardiac arrest, cardiac arrhythmia or Torsades de Pointes, A-V (Atrioventricular) block or structural heart disease
• Family history of long QT (Interval in the ECG: from the start of the QRS complex to the end) syndrome (either objectively diagnosed or suggested by sudden death due to cardiac causes before the age of 50 of a 1st degree relative)
• Family history of sudden cardiac death before the age of 50 of a 1st degree relative
• Use of prescription or non-prescription systemic or topical medicinal products (except routine vitamins, acetylsalicylic acid, paracetamol and contraceptives) within 3 weeks (or within 5 halflives of the medicinal product, whichever is longest) prior to the first dosing of semaglutide
• Smoking, drug or alcohol abuse

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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168 participants in 3 patient groups

Arm 1: semaglutide + moxifloxacin placebo

Experimental group

Description:

Subjects will receive a single dose of moxifloxacin placebo both before the start of semaglutide treatment and at the end of the semaglutide treatment.

Treatment:

Drug: semaglutide

Drug: placebo

Arm 2A:

Active Comparator group

Description:

Semaglutide placebo + moxifloxacin/moxifloxacin placebo: Subjects will receive moxifloxacin before the start of semaglutide placebo treatment and moxifloxacin placebo at the end of the semaglutide placebo treatment.

Treatment:

Drug: moxifloxacin

Drug: placebo

Arm 2B:

Experimental group

Description:

Semaglutide placebo + moxifloxacin placebo/moxifloxacin: Subjects will receive moxifloxacin placebo before the start of semaglutide placebo treatment and moxifloxacin at the end of the semaglutide placebo treatment.

Treatment:

Drug: moxifloxacin

Drug: placebo