A Phase 1 interventional study of Semaglutide 0.5 mg and Placebo (semaglutide 0.5 mg) in Diabetes and Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-15.
Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment
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.
Exclusion Criteria:
Participants will enter a 13 weeks treatment with 4 weeks dosing at dose level 0.25 mg and 9 weeks at 0.5 mg semaglutide.
Drug: Semaglutide 0.5 mg
Participants will enter a 13 weeks treatment with 4 weeks dosing at dose level 0.25 mg and 9 weeks at 0.5 mg semaglutide placebo.
Drug: Placebo (semaglutide 0.5 mg)
Participants will have 13 weeks treatment with 4 weeks dosing at dose level of 0.25 mg, 4 weeks at 0.5 mg, and 5 weeks at 1.0 mg semaglutide.
Drug: Semaglutide 1.0 mg
Participants will have 13 weeks treatment with 4 weeks dosing at dose level of 0.25 mg, 4 weeks at 0.5 mg, and 5 weeks at 1.0 mg semaglutide placebo.
Drug: Placebo (semaglutide 1.0 mg)
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.
Area under the semaglutide plasma concentration time curve at steady state (semaglutide 0.5 mg)
Calculated based on semaglutide measured in blood.
Time frame: 0-168 hours after last administration of semaglutide
Area under the semaglutide plasma concentration time curve at steady state (semaglutide 1.0 mg)
Calculated based on semaglutide measured in blood.
Time frame: 0-168 hours after last administration of semaglutide
Maximum observed semaglutide plasma concentration at steady state
Calculated based on semaglutide measured in blood.
Time frame: 0-168 hours after last administration of semaglutide
Time to maximum observed semaglutide plasma concentration at steady state
Calculated based on semaglutide measured in blood.
Time frame: 0-168 hours after last administration of semaglutide
Total apparent clearance of semaglutide at steady state
Calculated based on semaglutide measured in blood.
Time frame: 0-168 hours after last administration of semaglutide
Terminal elimination half-life of semaglutide at steady state
Calculated based on semaglutide measured in blood.
Time frame: 0-840 hours after last administration of semaglutide
Apparent volume of distribution of semaglutide at steady state
Calculated based on semaglutide measured in blood.
Time frame: 0-840 hours after last administration of semaglutide
Trough plasma semaglutide concentration
Calculated based on semaglutide measured in blood.
Time frame: Before dosing at day 29, 57, 78, 85 and 92
Dose-corrected accumulation ratio
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
Area under the semaglutide plasma concentration time curve
Calculated based on semaglutide measured in blood.
Time frame: 0-168 hours after the first dose of semaglutide 0.25 mg (starting dose level)
Maximum observed semaglutide plasma concentration
Calculated based on semaglutide measured in blood.
Time frame: 0-168 hours after the first dose of semaglutide 0.25 mg (starting dose level)
Time to maximum observed semaglutide plasma concentration
Calculated based on semaglutide measured in blood.
Time frame: 0-168 hours after the first dose of semaglutide 0.25 mg (starting dose level)
Number of treatment emergent adverse events (TEAEs)
Count and % of adverse events
Time frame: Visit 2 (Day 1) - visit 23 (Day 120-127)
Number of hypoglycaemic episodes
Count of episodes
Time frame: Visit 2 (Day 1) - visit 23 (Day 120-127)
Incidence of anti-semaglutide antibodies (positive/negative) at follow-up
Count of episodes
Time frame: Visit 23 (Day 120-127)
Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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