Novo Nordisk Investigational Site
Beijing, 100730, China
NCT Number: NCT03288740
The main purpose of the trial is to assess the pharmacokinetics of semaglutide (i.e. the way the drug is distributed in the body over a period of time) following once-weekly administration of semaglutide in healthy Chinese subjects. Different dose levels (0.5 and 1.0 mg) will be investigated in this trial. Participants will be administered semaglutide or placebo once-weekly by subcutaneous injection (under the skin fold of the abdominal wall) using a pen injector with a very small, thin needle by the trial doctor at the trial site for 13 weeks. The trial consists of 23 visits in total, including visit for screening and safety tests, visit for dose administration and blood sample collection. The total time of participation will be approximately 18-22 weeks depending on participant's individual visit schedule.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Beijing, 100730, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A dose of 0.25 mg semaglutide gradually increased to 0.5 mg injected subcutaneously (under the skin) once weekly for 13 weeks.
A dose of 0.25 mg semaglutide placebo gradually increased to 0.5 mg injected subcutaneously (under the skin) once weekly for 13 weeks.
A dose of 0.25 mg semaglutide gradually increased to 1.0 mg injected subcutaneously (under the skin) once weekly for 13 weeks.
A dose of 0.25 mg semaglutide placebo gradually increased to 1.0 mg injected subcutaneously (under the skin) once weekly for 13 weeks.
Time frame: 0-168 hours after last administration of semaglutide
Calculated based on semaglutide measured in blood.
Time frame: 0-168 hours after last administration of semaglutide
Calculated based on semaglutide measured in blood.
Time frame: 0-168 hours after last administration of semaglutide
Calculated based on semaglutide measured in blood.
Time frame: 0-168 hours after last administration of semaglutide
Calculated based on semaglutide measured in blood.
Time frame: 0-168 hours after last administration of semaglutide
Calculated based on semaglutide measured in blood.
Time frame: 0-840 hours after last administration of semaglutide
Calculated based on semaglutide measured in blood.
Time frame: 0-840 hours after last administration of semaglutide
Calculated based on semaglutide measured in blood.
Time frame: Before dosing at day 29, 57, 78, 85 and 92
Calculated based on semaglutide measured in blood.
Time frame: Based on the area under the semaglutide plasma concentration curve from 0-168 hours after the first dose and the area under the semaglutide plasma concentration curve 0-168 hours after the last dose
Calculated based on semaglutide measured in blood.
Time frame: 0-168 hours after the first dose of semaglutide 0.25 mg (starting dose level)
Calculated based on semaglutide measured in blood.
Time frame: 0-168 hours after the first dose of semaglutide 0.25 mg (starting dose level)
Calculated based on semaglutide measured in blood.
Time frame: 0-168 hours after the first dose of semaglutide 0.25 mg (starting dose level)
Calculated based on semaglutide measured in blood.
Time frame: Visit 2 (Day 1) - visit 23 (Day 120-127)
Count and % of adverse events
Time frame: Visit 2 (Day 1) - visit 23 (Day 120-127)
Count of episodes
Time frame: Visit 23 (Day 120-127)
Count of episodes
Novo Nordisk A/S
Industry
A Single-centre, Randomised, Double-blind, Placebo-controlled, Multiple-dose Trial to Assess the Pharmacokinetics, Safety and Tolerability of Semaglutide in Healthy Chinese Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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