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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1296-8015 | Other Identifier | World Health Organization (WHO) |
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The study is testing a new study medicine to treat people living with overweight or obesity. The aim of this study is to see if the medicine is safe, how it works in your body, and what your body does to the study medicine. Participants will either get the study medicine or placebo (a "dummy medicine" similar to the study medicine but without active ingredients) given as an injection under your skin. Which treatment the participants get is decided by chance. The study medicine is a potential new medicine which cannot be prescribed by doctors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC0638-0355 | Experimental | Participants will be randomized to receive NNC0638-0355. The study will be conducted in 5 parts. Part A: Single ascending dose (SAD) Part B, C, D and E: Multiple ascending dose (MAD). |
|
| Placebo | Placebo Comparator | Participants will be randomized to receive Placebo. The study will be conducted in 5 parts. Part A: Single ascending dose (SAD). Part B, C,D and E: Multiple ascending dose (MAD). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0638-0355 | Drug | NNC0638-0355 will be administered as a subcutaneous (s.c. under the skin) injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Number of treatment emergent adverse events (TEAE) | Measured as Number of events | From NNC0638-0355 administration (day 1) to completion of the end of study visit (6 weeks) |
| Part B,C,D and E : Number of treatment emergent adverse events (TEAE) | Measured as Number of events | From first NNC0638-0355 administration (day 1) to completion of the end of study visit (20 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: AUC; area under the NNC0638-0355 plasma concentration-time curve | Measured in hours*nano mole per litre (h*nmol/L) | From NNC0638-0355 administration (day 1) to completionof the end of study visit (6 weeks) |
| Part A: Cmax; maximum observed NNC0638-0355 plasma concentration |
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Key inclusion criteria
Key exclusion criteria
Known or suspected hypersensitivity to study intervention(s) or related products.
Any condition, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
HbA1c greater than or equal to 6.5 percentage (48 mmol/mol) at screening.
Any laboratory safety parameters at screening outside the below laboratory ranges, see designated reference range documents for specific values:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON | San Antonio | Texas | 78209 | United States |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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Sponsor staff involved in the clinical trial is masked according to company standard procedures.
| Placebo (NNC0638-0355) | Drug | Placebo matching NNC0638-0355 will be administered as subcutaneous (s.c. under the skin) injection. |
|
Measured in nano mole per litre (nmol/L) |
| From NNC0638-0355 administration (day 1) to completionof the end of study visit (6 weeks) |
| Part B,C,D and E: AUC; area under the NNC0638-0355 plasma concentration-time curve | Measured in hour*nano mole per litre (h*nmol/L) | From first NNC0638-0355 administration (day 1) to completionof the end of study visit (20 weeks) |
| Part B,C,D and E: Cmax; maximum observed NNC0638-0355 plasma concentration | Measured in nano mole per litre (nmol/L) | From first NNC0638-0355 administration (day 1) to completionof the end of study visit (20 weeks) |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |