Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1304-7446 | 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
Not provided
This study is testing a new study medicine which may be used to treat people living with overweight or obesity. The purpose of the study is to see if the new study medicine is safe, how it works in human body and what human body does to the study medicine. Participants will either get the study medicine NNC0662-0419 or placebo (a "dummy" medicine without any active ingredients) given by study staff as an injection under participants skin. Which treatment participants will get is decided by chance. NNC0662-0419 is a new medicine, which cannot be prescribed by doctors. This is the first time the medicine is being given to humans. The study will last for about 9 months.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Single ascending dose (SAD) | Experimental | Participants will receive a single dose of any of the five different dose levels of NNC0662-0419 or matching placebo in a sequential manner with the dose increasing between cohorts. |
|
| Part B: Multiple ascending dose (MAD) | Experimental | Participants will receive NNC0662-0419 once-weekly for 4 weeks at any of the four different dose levels or matching placebo in a sequential manner with the dose increasing between cohorts. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0662-0419 | Drug | Participants will receive NNC0662-0419 subcutaneous (s.c.) once weekly. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Number of treatment emergent adverse events (TEAE) | Number of events | From timing of dosing on day 1 until completion of the end of study visit (up to 6 weeks) |
| Part B: Number of treatment-emergent adverse events (TEAE) | Number of events | From timing of dosing on day 1 until completion of the end of study visit (up to 9 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: AUC; the area under the NNC0662-0419 plasma concentration-time curve | measured in hour*nanomoles per liter (h*nmol/L) | From pre-dose on day 1 until completion of the end of study visit (up to 6 weeks) |
| Part A: Cmax; the maximum plasma concentration of NNC0662-0419 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion, Lincoln | Lincoln | Nebraska | 68502 | United States |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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 (NNC0662-0419) | Other | Participants will receive placebo matched to NNC0662-0419 s.c. once weekly. |
|
measured in nanomoles per liter(nmol/L) |
| From pre-dose on day 1 until completion of the end of study visit (up to 6 weeks) |
| Part B: AUC; the area under the NNC0662-0419 plasma concentration-time curve | measured in h*nmol/L | From pre-dose on day 1 until completion of the end of study visit (up to 9 weeks) |
| Part B: Cmax; the maximum plasma concentration of NNC0662-0419 | measured in nmol/L | From pre-dose on day 1 until completion of the end of study visit (up to 9 weeks) |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |