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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1311-5582 | Other Identifier | WHO |
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The study is testing a new medicine (NNC0487-0111) for weight control in Chinese people with BMI between 24 kilogram per meter square (kg/m2) and 34.9 kg/m2. The aim of the study is to see how safe the study medicine is and how it behaves in human body. Participants will either get the study medicine or placebo (a "dummy medicine" similar to the study medicine but without active ingredients) and which treatment they get is decided by chance. The study medicine is a potential new medicine which cannot be prescribed by doctors but has previously been tested in humans. This study will last for up to 53 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A1 | Experimental | Cohort A1 will include 12 participants randomised (3:1), with 9 participants being randomised to receive a single dose level 1 of active treatment and 3 participants randomised to receive placebo. |
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| Cohort A2 | Experimental | Cohort A2 will include 12 participants randomised (3:1), with 9 participants being randomised to receive a single dose level 2 of active treatment and 3 participants randomised to receive placebo. |
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| Cohort A3 | Experimental | Cohort A3 will include 12 participants randomised (3:1), with 9 participants being randomised to receive a single dose level 3 of active treatment and 3 participants randomised to receive placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0487-0111 A | Drug | Participants will receive single dose (level 1, level 2, level 3) injection of NNC0487-0111 A subcutaneoulsy. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment emergent adverse events (TEAEs) | Number of events | From NNC0487-0111 administration (Day 1) to completion of the end of study visit (Day 23) |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-∞,SD; the area under the NNC0487-0111 plasma concentration-time curve from time 0 to infinity after a single dose | h*nmol/L | From pre-dose on Day 1 until completion of the end of study visit (Day 23) |
| Cmax,SD; the maximum plasma concentration of NNC0487-0111 after a single dose |
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Inclusion Criteria:
Exclusion Criteria:
Any condition, unwillingness or inability which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
HbA1c ≥ 6.5 percent (%) [48 milimol per mole (mmol/mol)] at screening.
Any laboratory safety parameters at screening outside the below laboratory ranges:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency dept. 2834 | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jinan Central Hospital | Jinan | Shandong | 250000 | China |
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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Sponsor staff involved in the clinical trial is masked according to company standard procedures.
| Placebo A | Drug | Participants will receive single dose (level 1, level 2, level 3) injection of placebo A subcutaneoulsy. |
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nmol/L |
| From pre-dose on Day 1 until completion of the end of study visit (Day 23) |
| tmax,SD; the time of maximum plasma concentration of NNC0487-0111 after a single dose | h | From pre-dose on Day 1 until completion of the end of study visit (Day 23) |
| t1/2,SD; the terminal half-life of NNC0487-0111 after a single dose | h | From pre-dose on Day 1 until completion of the end of study visit (Day 23) |
| Relative change in body weight | From baseline Day 1 until completion of the end of study visit (Day 23) |
| Change in fasting plasma glucose | mmol/L | From baseline Day 1 until completion of the end of study visit (Day 23) |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |