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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1295-4056 | Other Identifier | World Health Organization (WHO) |
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This study will look at how CagriSema affects the blood levels of atorvastatin and warfarin. The study will look at the levels of warfarin and atorvastatin in the blood before the participant starts taking CagriSema and if this changes after the participant has taken CagriSema. The study will also investigate the effect of warfarin before and after the participant takes CagriSema and assess if the injection site affects the level of CagriSema in the blood. The study will last for about 8 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CagriSema +Atorvastatin + Warfarin | Experimental | Participants will receive a single dose of atorvastatin and a single dose of warfarin followed by a 16-week CagriSema dose escalation period and a 7-week CagriSema maintenance period. Participants will also receive a single dose of atorvastatin and a single dose of warfarin in the maintenance period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cagrilintide | Drug | Cagrilintide will be administered subcutaneously once weekly. |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-72hours,atorv,SD: Area under the atorvastatin plasma concentration-time curve from time 0 to 72 hours after a single dose of atorvastatin without CagriSema exposure and at CagriSema steady state | Measured in hours*nanomoles per liter (hours*nmol/L). | Day 1 (pre-dose to 72 hours post-dose) and day 171 (pre-dose to 72 hours post-dose) |
| AUC0-168hours,S-war,SD: Area under the S-warfarin plasma concentration-time curve from time 0 to 168 hours after a single dose of warfarin without CagriSema exposure and at CagriSema steady state | Measured in hours*nmol/L. | Day 8 (pre-dose to 168 hours post-dose) and day 178 (pre-dose to 168 hours post-dose) |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-∞,atorv,SD: Area under the atorvastatin plasma concentration curve from time 0 to infinity after single dose of atorvastatin without CagriSema exposure and at CagriSema steady state | Measured in hours*nmol/L. | Day 1 (pre-dose to 72 hours post-dose) and day 171 (pre-dose to 72 hours post-dose) |
| Cmax,atorv,SD: Maximum observed atorvastatin plasma concentration after single dose of atorvastatin without CagriSema exposure and at CagriSema steady state |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altasciences Company Inc. | Montreal | Quebec | H3P 3P1 | Canada |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000717792 | cagrilintide |
| C000591245 | semaglutide |
| D000069059 | Atorvastatin |
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Semaglutide | Drug | Semaglutide will be administered subcutaneously once weekly. |
|
| Atorvastatin | Drug | Atorvastatin will be administered as a single dose orally 2 times during the study. |
|
| Warfarin | Drug | Warfarin will be administered as a single dose orally 2 times during the study. |
|
Measured in nanomoles per liter (nmol/L). |
| Day 1 (pre-dose to 72 hours post-dose) and day 171 (pre-dose to 72 hours post-dose) |
| tmax,atorv,SD: Time to maximum observed atorvastatin plasma concentration after single dose of atorvastatin without CagriSema exposure and at CagriSema steady state | Measured in hours. | Day 1 (pre-dose to 72 hours post-dose) and day 171 (pre-dose to 72 hours post-dose) |
| AUC0-∞,S-war,SD: Area under the S-warfarin plasma concentration curve from time 0 to infinity after single dose of warfarin without CagriSema exposure and at CagriSema steady state | Measured in hours*nmol/L. | Day 8 (pre-dose to 168 hours post-dose) and day 178 (pre-dose to 168 hours post-dose) |
| Cmax,S-war,SD: Maximum observed S-warfarin plasma concentration after single dose of warfarin without CagriSema exposure and at CagriSema steady state | Measured in nmol/L. | Day 8 (pre-dose to 168 hours post-dose) and day 178 (pre-dose to 168 hours post-dose) |
| tmax,S-war,SD: Time to maximum observed S-warfarin plasma concentration after single dose of warfarin without CagriSema exposure and at CagriSema steady state | Measured in hours. | Day 8 (pre-dose to 168 hours post-dose) and day 178 (pre-dose to 168 hours post-dose) |
| iAUCINR,0-168hours: Incremental area under the INR-curve from 0 to 168 hours after single dose of warfarin without CagriSema exposure and at CagriSema steady state | Measured in hours*nmol/L. | Day 8 (pre-dose to 168 hours post-dose) and day 178 (pre-dose to 168 hours post-dose) |
| INRmax: Maximum observed INR response after single dose of warfarin without CagriSema exposure and at CagriSema steady state | Measured in ratio. | Day 8 (pre-dose to 168 hours post-dose) and day 178 (pre-dose to 168 hours post-dose) |
| tINRmax: Time to maximum observed INR response after single dose of warfarin without CagriSema exposure and at CagriSema steady state | Measured in hours. | Day 8 (pre-dose to 168 hours post-dose) and day 178 (pre-dose to 168 hours post-dose) |
| Rac,0-168hours,cagri: The ratio of the area under the cagrilintide plasma concentration curve from 0 to 168 hours after the 4th dose of CagriSema to the area under the plasma concentration curve from 0 to 168 hours after the 1st dose | Measured in ratio. | Day 23 (pre-dose to 168 hours post-dose) and day 44 (pre-dose to 168 hours post-dose) |
| Rac,0-168hours,sema: The ratio of the area under the semaglutide plasma concentration curve from 0 to 168 hours after the 4th dose of CagriSema to the area under the plasma concentration curve from 0 to 168 hours after the 1st dose | Measured in ratio. | Day 23 (pre-dose to 168 hours post-dose) and day 44 (pre-dose to 168 hours post-dose |
| AUC0-168hours, 4th dose cagri: Area under the cagrilintide plasma concentration curve from 0 to 168 hours after 4th dose of CagriSema | Measured in hours*nmol/L. | Day 44 (pre-dose to 168 hours post-dose) |
| AUC0-168hours,4th dose Sema: Area under the semaglutide plasma concentration curve from 0 to 168 hours after 4th dose of CagriSema | Measured in hours*nmol/L. | Day 44 (pre-dose to 168 hours post-dose) |
| AUC0-168hours, cagri 2.4mg, SS: Area under the cagrilintide plasma concentration curve from 0 to 168 hours at steady state | Measured in hours*nmol/L. | Day 163 (pre-dose to 168 hours post-dose) |
| AUC0-168hours, sema 2.4mg, SS: Area under the semaglutide plasma concentration curve from 0 to 168 hours at steady state | Measured in hours*nmol/L. | Day 163 (pre-dose to 168 hours post-dose) |
| Cmax, cagri, SS: Maximum observed cagrilintide plasma concentration at steady state | Measured in nmol/L. | Day 163 (pre-dose to 168 hours post-dose) |
| tmax, cagri, SS: Time to maximum observed cagrilintide plasma concentration at steady state | Measured in hours. | Day 163 (pre-dose to 168 hours post-dose) |
| Cmax, sema,SS: Maximum observed semaglutide plasma concentration at steady state | Measured in nmol/L. | Day 163 (pre-dose to 168 hours post-dose) |
| tmax, sema, SS: Time to maximum observed semaglutide plasma concentration at steady state | Measured in hours. | Day 163 (pre-dose to 168 hours post-dose) |
| CL/Fcagri,SS: total apparent clearance of cagrilintide at steady state | Measured in litres per hour (L/h). | Day 163 (pre-dose to 168 hours post-dose) |
| CL/Fsema,SS: total apparent clearance of semaglutide at steady state | Measured in litres per hour (L/h). | Day 163 (pre-dose to 168 hours post-dose) |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |