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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1289-3164 | Other Identifier | World Health Organization (WHO) |
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The study is testing a new study medicine called NNC0487-0111 for weight control in Chinese people with Body mass index (BMI) greater than or equal to (>=) 24 kilogram per square meter (kg/m^2). The aim of this study is to find out how safe the study medicine is and how it behaves in your body. Participants will either get NNC0487-0111 or placebo. Which treatment participants will get is decided by chance. Oral NNC0487-0111 is a new medicine which cannot be prescribed by doctors but has previously been tested in humans. The study will last for about 60 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC0487-0111 (dose 1) | Experimental | Participants will be randomized to receive a single dose of NNC0487-0111. |
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| NNC0487-0111 (dose 2) | Experimental | Participants will be randomized to receive a single dose of NNC0487-0111. |
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| NNC0487-0111 (dose 3) | Experimental | Participants will be randomized to receive a single dose of NNC0487-0111. |
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| Placebo | Placebo Comparator | Participants will be randomized to receive matching Placebo to NNC0487-0111. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0487-0111 | Drug | Participants will be randomized to receive NNC0487-0111 tablet orally at dose levels 1, 2, or 3. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment emergent adverse events (TEAEs) | Number of events | From first NNC0487-0111 administration (Day 1) to completion of the end-of-study visit (Day 31) |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-24h,MD; the area under the NNC0487-0111 plasma concentration-time curve from time 0 to 24 hours after last multiple dose | measured in hour*nanomoles per liter (h*nmol/L) | From pre-dose on Day 10 until Day 11 |
| Cmax,MD; the maximum plasma concentration of NNC0487-0111 after last multiple dose |
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Inclusion Criteria:
Exclusion Criteria:
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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 Affiliated to Shandong University | Ji'Nan | Shandong | 250000 | China | ||
| Jinan Central Hospital |
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 (NNC0487-0111) | Drug | Participants will be randomized to receive a placebo tablet orally matched to NNC0487-0111. |
|
measured in nanomoles per liter(nmol/L) |
| From pre-dose on Day 10 to completion of the end-of-study visit (Day 31) |
| tmax,MD; the time of maximum plasma concentration of NNC0487-0111 after last multiple dose | measured in hour (h) | From pre-dose on Day 10 to completion of the end-of-study visit (Day 31) |
| Change in bodyweight | measured in percentage (%) | From baseline Day 1 to Day 11 |
| Change in fasting plasma glucose | measured in millimoles per liter (mmol/L) | From baseline Day 1 to Day 11 |
| Ji'Nan |
| Shandong |
| 250000 |
| China |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |