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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02064348
• Other study ID #: NN9535-3652
• Secondary ID: 2012-005073-31U1
• Status: Completed
• Phase: Phase 1
• Start date: February 26, 2014
• Est. completion date: April 23, 2015

Study information

• Verified date: June 2018
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: April 23, 2015
• Est. primary completion date: April 23, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Healthy

Intervention

Drug:
• semaglutide
Solution for subcutaneous (s.c., under the skin) injection. Dose escalation to 1.5 mg.
• placebo
Solution for s.c. injection or tablets for oral administration
• moxifloxacin
Tablets for oral administration

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Demmel V, Sandberg-Schaal A, Jacobsen JB, Golor G, Pettersson J, Flint A. No QTc Prolongation with Semaglutide: A Thorough QT Study in Healthy Subjects. Diabetes Ther. 2018 May 24. doi: 10.1007/s13300-018-0442-0. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   Clinical Trials at Novo Nordisk