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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1336-5994 | Other Identifier | World Health Organization (WHO) |
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The purpose of this clinical study is to compare 2 different versions cagrilintide and see how these work in people living with excess body weight. Participant will get either cagrilintide B or cagrilintide D injections. Which treatment participant will get is decided by chance. Participant will be in this clinical study for about 14 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cagrilintide B | Experimental | Participants will receive cagrilintide B subcutaneously once weekly for 5 weeks. |
|
| Cagrilintide D | Experimental | Participants will receive cagrilintide D subcutaneously once weekly for 5 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cagrilintide B | Drug | Cagrilintide B will be administered subcutaneously. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUCss: area under the total cagrilintide concentration-time curve at steady state after 5th dosing of cagrilintide | Measured as hour*nanomole per liter (h*nmol/L). | From Pre-dose at Day 29 to Day 36 |
| Cmax,ss: maximum observed concentration of total cagrilintide at steady state after 5th dosing of cagrilintide | Measured as nanomole per liter (nmol/L). | From Pre-dose at Day 29 to Day 36 |
| Measure | Description | Time Frame |
|---|---|---|
| AUCss: area under the total cagrilintide concentration-time curve at steady state after 4th dosing of cagrilintide | Measured as h*nmol/L. | From Pre-dose at Day 22 to Day 29 |
| Cmax,ss: maximum observed concentration of total cagrilintide at steady state after 4th dosing of cagrilintide |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Previous dosing of marketed or non-marketed amylin-agonists (a).
Any condition, unwillingness or inability which in the investigator's opinion might jeopardise the participant's safety or compliance with the protocol (a).
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion, Phoenix | Tempe | Arizona | 85283 | United States |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Cagrilintide D |
| Drug |
Cagrilintide D will be administered subcutaneously. |
|
Measured as nmol/L. |
| From Pre-dose at Day 22 to Day 29 |
| AUCss: area under the total cagrilintide concentration-time curve at steady state after 1st dosing of cagrilintide | Measured as h*nmol/L. | From Pre-dose at Day 1 to Day 8 |
| Cmax,ss: maximum observed concentration of total cagrilintide at steady state after 1st dosing of cagrilintide | Measured as nmol/L. | From Pre-dose at Day 1 to Day 8 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |