Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1149-6572 | Other Identifier | World Health Organization (WHO) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Semaglutide 0.5 mg | Experimental | 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. |
|
| Semaglutide 0.5 mg placebo | Placebo Comparator | 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. |
|
| Semaglutide 1.0 mg | Experimental | 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. |
|
| Semaglutide 1.0 mg placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide 0.5 mg | Drug | A dose of 0.25 mg semaglutide gradually increased to 0.5 mg injected subcutaneously (under the skin) once weekly for 13 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the semaglutide plasma concentration time curve at steady state (semaglutide 0.5 mg) | Calculated based on semaglutide measured in blood. | 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. | 0-168 hours after last administration of semaglutide |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed semaglutide plasma concentration at steady state | Calculated based on semaglutide measured in blood. | 0-168 hours after last administration of semaglutide |
| Time to maximum observed semaglutide plasma concentration at steady state |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Beijing | 100730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33159658 | Result | Shi A, Xie P, Nielsen LL, Skjoth TV, He X, Haugaard SP. Pharmacokinetics, Safety and Tolerability of Once-Weekly Subcutaneous Semaglutide in Healthy Chinese Subjects: A Double-Blind, Phase 1, Randomized Controlled Trial. Adv Ther. 2021 Jan;38(1):550-561. doi: 10.1007/s12325-020-01548-y. Epub 2020 Nov 7. |
Not provided
Not provided
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
| Placebo (semaglutide 0.5 mg) | Drug | A dose of 0.25 mg semaglutide placebo gradually increased to 0.5 mg injected subcutaneously (under the skin) once weekly for 13 weeks. |
|
| Semaglutide 1.0 mg | Drug | A dose of 0.25 mg semaglutide gradually increased to 1.0 mg injected subcutaneously (under the skin) once weekly for 13 weeks. |
|
| Placebo (semaglutide 1.0 mg) | Drug | A dose of 0.25 mg semaglutide placebo gradually increased to 1.0 mg injected subcutaneously (under the skin) once weekly for 13 weeks. |
|
Calculated based on semaglutide measured in blood.
| 0-168 hours after last administration of semaglutide |
| Total apparent clearance of semaglutide at steady state | Calculated based on semaglutide measured in blood. | 0-168 hours after last administration of semaglutide |
| Terminal elimination half-life of semaglutide at steady state | Calculated based on semaglutide measured in blood. | 0-840 hours after last administration of semaglutide |
| Apparent volume of distribution of semaglutide at steady state | Calculated based on semaglutide measured in blood. | 0-840 hours after last administration of semaglutide |
| Trough plasma semaglutide concentration | Calculated based on semaglutide measured in blood. | Before dosing at day 29, 57, 78, 85 and 92 |
| Dose-corrected accumulation ratio | Calculated based on semaglutide measured in blood. | 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. | 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. | 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. | 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 | Visit 2 (Day 1) - visit 23 (Day 120-127) |
| Number of hypoglycaemic episodes | Count of episodes | Visit 2 (Day 1) - visit 23 (Day 120-127) |
| Incidence of anti-semaglutide antibodies (positive/negative) at follow-up | Count of episodes | Visit 23 (Day 120-127) |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000591245 | semaglutide |
Not provided
Not provided
Not provided