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

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

Official Title
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A Thorough QTc Evaluation of the Effect of Semaglutide on Cardiac Repolarisation in Healthy Subjects: A Randomised, Double-Blind,Placebo-Controlled, Three-Arm Parallel Trial With a Nested Cross-Over Design for Positive Control With Moxifloxacin Administration

Conditions
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Diabetes, Healthy

Intervention / Treatment
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* Drug: semaglutide
* Drug: placebo
* Drug: moxifloxacin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: semaglutide + moxifloxacin placebo<br>Subjects will receive a single dose of moxifloxacin placebo both before the start of semaglutide treatment and at the end of the semaglutide treatment. | Drug: semaglutide<br>* Solution for subcutaneous (s.c., under the skin) injection. Dose escalation to 1.5 mg.<br>Drug: placebo<br>* Solution for s.c. injection or tablets for oral administration<br>|
| Active Comparator: Arm 2A:<br>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. | Drug: placebo<br>* Solution for s.c. injection or tablets for oral administration<br>Drug: moxifloxacin<br>* Tablets for oral administration<br>|
| Experimental: Arm 2B:<br>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. | Drug: placebo<br>* Solution for s.c. injection or tablets for oral administration<br>Drug: moxifloxacin<br>* Tablets for oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |