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

Phase 1

Completed

• Conditions: Diabetes; Healthy
• Interventions: Drug: placebo; Drug: semaglutide; Drug: moxifloxacin

• Registration Number: NCT02064348
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-13
• Study First Submitted QC: 2014-02-13
• Study First Posted: 2014-02-17
• Study Start: 2014-02-26
• Primary Completion: 2015-04-23
• Study Completion: 2015-04-23
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-11
• Last Update Posted: 2018-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2A:	placebo	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.
Arm 1: semaglutide + moxifloxacin placebo	placebo	Subjects will receive a single dose of moxifloxacin placebo both before the start of semaglutide treatment and at the end of the semaglutide treatment.
Arm 2B:	placebo	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.
Arm 1: semaglutide + moxifloxacin placebo	semaglutide	Subjects will receive a single dose of moxifloxacin placebo both before the start of semaglutide treatment and at the end of the semaglutide treatment.
Arm 2A:	moxifloxacin	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.
Arm 2B:	moxifloxacin	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.

Primary Outcome Measures

Name	Time	Method
QTcI, (Individual heart rate corrected QT (Interval in the ECG: from the start of the QRS complex to the end) interval) based on ECG recordings obtained at 11 time points	0-48 hours after the fourth dose of semaglutide/semaglutide placebo at the 1.5 mg dose level

Secondary Outcome Measures

Name	Time	Method
QTcI, based on ECG (electrocardiogram) recordings obtained at 2 out of 8 time points	0-24 hours after a single dose of moxifloxacin/moxifloxacin placebo

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇪 Berlin, Germany