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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1314-9337 | Other Identifier | World Health Organization (WHO) | |
| 2025-521384-12 | Other Identifier | European Medical Agency (EMA) |
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This clinical study is testing two versions of the study medicine cagrilintide. The purpose of the study is to compare these two versions to understand their effects in participants with overweight or obesity. Participants will receive either cagrilintide version D or cagrilintide version B, and which treatment participants receive is decided by chance. Participants will be in this clinical study for about 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cagrilintide B and Placebo Semaglutide I | Experimental | Participants will receive Cagrilintide B and Placebo semaglutide I subcutaneously once weekly for up to 17 weeks. |
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| Cagrilintide D-Injection site 1 | Experimental | Participants will receive Cagrilintide D subcutaneously once weekly for up to 17 weeks. |
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| Cagrilintide D-Injection site 2 | Experimental | Participants will receive Cagrilintide D subcutaneously once weekly for up to 17 weeks. |
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| Cagrilintide D-Injection site 3 | Experimental | Participants will receive Cagrilintide D subcutaneously once weekly for up to 17 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cagrilintide D | Drug | Cagrilintide D will be administered subcutaneously. |
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| Measure | Description | Time Frame |
|---|---|---|
| AUC,ss: area under the total cagrilintide concentration-time curve at steady state after 5th dosing of cagrilintide s.c. | Measured in hour nanomoles per litre (h*nmol/L) | Day 113 (pre-dose) to Day 120 (post-dose) |
| Cmax,ss: maximum concentration of total cagrilintide at steady state after 5th dosing of cagrilintide s.c. | Measured in nanomoles per litre (nmol/L). | Day 113 (pre-dose) to Day 120 (post-dose) |
| Measure | Description | Time Frame |
|---|---|---|
| tmax,ss: time since last dosing to maximum concentration of totala cagrilintide at steady state after 5th dosing of cagrilintide s.c. | Measured in hours. | Day 113 (pre-dose) to Day 120 (post-dose) |
| t½,ss: terminal half-life of total cagrilintide at steady state after 5th dosing of cagrilintide s.c. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novo Nordisk | Contact | (+1) 866-867-7178 | clinicaltrials@novonordisk.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parexel International GmbH | Recruiting | Berlin | 14050 | Germany |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| Cagrilintide B and placebo semaglutide I | Drug | Cagrilintide B and placebo semaglutide I will be administered subcutaneously |
|
Measured in hours. |
| Day 113 (pre-dose) to Day 162 (post-dose) |
| Vz/F: the apparent volume of distribution of total cagrilintide during elimination after the 5th dosing of cagrilintide s.c. | Measured in litre. | Day 113 (pre-dose) to Day 120 (post-dose) |
| CL/F: total apparent clearance of total cagrilintide after the 5th dosing of cagrilintide s.c. | Measured in litre per hours. | Day 113 (pre-dose) to Day 120 (post-dose) |
| AUC,ss: area under the cagrilintide and metabolites concentration-time curve at steady state after the 5th dosing of cagrilintide s.c. | Measured in hours*nmol/L. | Day 113 (pre-dose) to Day 120 (post-dose) |
| Cmax,ss: maximum concentration of cagrilintide and metabolites at steady state after the 5th dosing of cagrilintide s.c. | Measured in nmol/L. | Day 113 (pre-dose) to Day 120 (post-dose) |
| tmax,ss: time since the last dosing to maximum concentration of cagrilintide and metabolites at steady state after the 5th dosing of cagrilintide s.c. | Measured in hours. | Day 113 (pre-dose) to Day 120 (post-dose) |
| t½,ss: terminal half-life of cagrilintide parent at steady state after the 5th dosing of cagrilintide s.c. | Measured in hours. | Day 113 (pre-dose) to Day 120 (post-dose) |
| AUC,ss: area under the total cagrilintide concentration-time curve at steady state after the 4th dosing of cagrilintide s.c | Measured in hours*nmol/L. | Day 22 (pre-dose) to Day 29 (post-dose) |
| Cmax,ss: maximum concentration of total cagrilintide at steady state after the 4th dosing of cagrilintide s.c. | Measured in nmol/L. | Day 22 (pre-dose) to Day 29 (post-dose) |
| tmax,ss: time since the last dosing to maximum concentration of total cagrilintide at steady state after the 4th dosing of cagrilintide s.c. | Measured in hours. | Day 22 (pre-dose) to Day 29 (post-dose) |
| Number of treatment-emergent adverse events (TEAEs) | Measured in count of events. | Day 1 (randomisation) to Day 162 (end of study) |
| Number of treatment-emergent serious adverse events (TESAEs) | Measured in count of events. | Day 1 (randomisation) to Day 162 (end of study) |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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