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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-003060-27 | EudraCT Number | ||
| U1111-1266-3910 | Other Identifier | WHO |
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Novo Nordisk is developing a combination therapy with the investigational drug NNC0480-0389 and an already approved medicine called "semaglutide" for the treatment of type-2 diabetes (T2D). It is expected that the combination will further improve the blood sugar control compared to semaglutide therapy alone. The study will investigate the influence of the combination of semaglutide and NNC0480-0389 on the blood levels of a birth control pill (a combined oral contraceptive consisting of ethinylestradiol and levonorgestrel) and paracetamol. Participants will get semaglutide and NNC0480-0389 as injection under the skin of their belly using a pen-injector. The injections will be given once weekly for 14 weeks. Additionally, participants will at two occasions get paracetamol as soluble tablet in connection with a standardised breakfast meal. Further, participants will get the birth control pill in form of tablets in two periods of 8 days each. Participants will get the combination of semaglutide and NNC0480-0389 as well as paracetamol and the combined contraceptive in any case. The study participation will last up to about 24 weeks. Participants will have 25 visits at the study centre. For 4 of the visits participants will stay at the study centre; the remaining visits will be outpatient. Only healthy postmenopausal women can take part in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One-sequence cross-over arm | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide 1.34 mg/mL | Drug | Semaglutide will be administered at a dose of 0.25, 0.50 or 1.0 mg as indicated on scale drum once weekly by subcutaneous (s.c.) (under the skin) injections in the abdomen for 14 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the ethinylestradiol plasma concentration time curve during a dosing interval (0 to 24 hours) at steady state (AUC0-24h,EE,SS) | Measured in h*pg/mL | From pre-dose to 24 hours after last dosing of oral contraceptive on day 8 and day 100 |
| Area under the levonorgestrel plasma concentration time curve during a dosing interval (0 to 24 hours) at steady state (AUC0-24h,LN,SS) | Measured in h*pg/mL | From pre-dose to 24 hours after last dosing of oral contraceptive on day 8 and day 100 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration of ethinylestradiol at steady state (Cmax,EE,SS) | Measured in pg/mL | Within pre-dose to 24 hours after last dosing of oral contraceptive on day 8 and day 100 |
| Maximum concentration of levonorgestrel at steady state (Cmax,LN,SS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency dept. 1452 | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Berlin | 10117 | Germany |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| Semaglutide 3.0 mg/mL | Drug | Semaglutide will be administered at a dose of 2.0 mg corresponding to the increment of 67 (pen injector units) as indicated on scale drum. once weekly by subcutaneous (s.c.) (under the skin) injections in the abdomen for 14 weeks. |
|
| NNC0480-0389 10 mg/mL | Drug | NNC0480-0389 will be administered at a dose of 0.23, 0.45 or 0.90 mL once weekly by s.c. (under the skin) injections for 14 weeks. |
|
| NNC0480-0389 30 mg/mL | Drug | NNC0480-0389 will be administered at a dose of 0.60 mL once weekly by s.c. (under the skin) injections for 14 weeks. |
|
| Microgynon® | Drug | Microgyn® will be given as once daily oral dosing in two periods, each of 8 days' duration. One tablet contains levonorgestrel 0.15 mg and ethinylestradiol 0.03 mg. |
|
Measured in pg/mL
| Within pre-dose to 24 hours after last dosing of oral contraceptive on day 8 and day 100 |
| Area under the paracetamol concentration-time curve for 0-60 minutes following a standardised meal (AUC0-60min,para) | Measured in h*μg/mL | From pre-dose to 60 minutes after dosing of paracetamol on day 1 and day 93 |
| Area under the paracetamol concentration-time curve for 0-300 minutes following a standardised meal (AUC0-300min,para) | Measured in h*μg/mL | From pre-dose to 300 minutes after dosing of paracetamol on day 1 and day 93 |
| Maximum observed paracetamol concentration following a standardised meal (Cmax,para) | Measured in μg/mL | Within pre-dose to 300 minutes after dosing of paracetamol on day 1 and day 93 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
| C072593 | ethinyl estradiol, levonorgestrel drug combination |
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