Comparing Semaglutide Administered Subcutaneously Once Daily to Semaglutide Administered Subcutaneously Once Weekly
- Registration Number
- NCT02557620
- Lead Sponsor
- Novo Nordisk A/S
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 113
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description semaglutide OW + placebo semaglutide OD semaglutide - semaglutide OW + placebo semaglutide OD placebo - semaglutide OD + placebo semaglutide OW placebo - placebo semaglutide OW + placebo semaglutide OD placebo - semaglutide OD + placebo semaglutide OW semaglutide -
- Primary Outcome Measures
Name Time Method Area under the semaglutide concentration-time curves At steady-state from 0 to168 hours after dosing on day 78
- Secondary Outcome Measures
Name Time Method Area under the the single dose concentration-time curve From 0 to 300 min after administration of paracetamol (1.5 g) at day 79 Maximum observed semaglutide plasma concentration At steady-state derived from the concentration-time curves, within 168 hours from day 78 Number of treatment emergent adverse events (TEAEs) From baseline (day 1, post-dose) to last follow-up visit (day 120)
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇩🇪Berlin, Germany