Comparing Semaglutide Administered Subcutaneously Once Daily to Semaglutide Administered Subcutaneously Once Weekly

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial is conducted in Europe. The aim of this trial is to compare the steady-state exposure of semaglutide administered subcutaneously once daily to semaglutide administered subcutaneously once weekly in healthy subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novo Nordisk A/S

Criteria

Inclusion Criteria:

• Male or female, aged 18-55 years (both inclusive) at the time of signing informed consent

• Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, ECG and clinical laboratory tests performed during the screeningvisit, as judged by the investigator

• Body mass index (BMI) between 20.0 and 29.9 kg/m^2 (both inclusive)

• HbA1c (glycosylated haemoglobin) below 6.5%

Exclusion Criteria:

• Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method throughout the trial including the 5 weeks follow-up period (adequate contraceptive measures as required by local regulation or practice)

• Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol

• History of pancreatitis (acute or chronic)

• Screening calcitonin equal or above 50 ng/L

• Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN2) or Medullary Thyroid Carcinoma (MTC)