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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1300-3720 | Other Identifier | Universal Trial Number |
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This study consists of two phases: Phase A and Phase B. Participants are being asked to participate in both phases. Phase A of this study is comparing two formulations of a study medicine called NNC0487-0111 for weight control in people with overweight or obesity. Phase B of this study is testing how taking NNC0487-0111 at the same time as a meal affects the way NNC0487-0111 works in participants body. The aim of this study is to compare how two different formulations of NNC0487-0111 behave in the body, and how their function is affected when they are taken with or without a meal. Participants will either get NNC0487-0111 Formulation C, or NNC0487-0111 Formulation D. Both formulations are given as tablets. Which treatment participants 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 5 - 6 months (155-184 days).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase A: NNC0487-0111 (formulation D) | Experimental | Participants will receive once daily dose of six different dose levels (1-6) of NNC0487-0111 (formulation D) at increasing doses (the dose will be escalated every 3 weeks). |
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| Phase A: NNC0487-0111 (formulation C) | Active Comparator | Participants will receive once daily dose of six different dose levels (1-6) of NNC0487-0111 (formulation C) at increasing doses (the dose will be escalated every 3 weeks). |
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| Phase B: NNC0487-0111 (formulation D) | Experimental | Participants will receive once daily dose of dose level 6 of NNC0487-0111 (formulation D). |
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| Phase B: NNC0487-0111 (formulation C) | Active Comparator | Participants will receive once daily dose of dose level 6 of NNC0487-0111 (formulation C). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0487-0111 (formulation D) | Drug | Participants will receive NNC0487-0111 (formulation D) tablet once daily. |
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| Measure | Description | Time Frame |
|---|---|---|
| Phase A: The area under the NNC0487-0111 plasma concentration-time curve during a dosing interval at steady state | Measured as hours*nanomoles per liter (h*nmol/L) | From pre-dose to after dosing on days 21, 42, 63, 84, 105 and 126 |
| Measure | Description | Time Frame |
|---|---|---|
| Phase A: The maximum observed plasma concentration of NNC0487-0111 at steady state | Measured as nanomoles per liter (nmol/L) | From pre-dose to after dosing on days 21, 42, 63, 84, 105 and 126 |
| Phase A: The time from dose administration to maximum observed plasma concentration of NNC0487-0111 at steady state |
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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 |
|---|---|---|---|---|---|---|
| Celerion, Lincoln | Lincoln | Nebraska | 68502 | United States |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Single-blinded to the investigator (to the formulation).
| NNC0487-0111 (formulation C) | Drug | Participants will receive NNC0487-0111 (formulation C) tablet once daily. |
|
Measured as hours |
| From pre-dose to after dosing on days 21, 42, 63, 84, 105 and 126 |
| Phase B: The area under the NNC0487-0111 plasma concentration-time curve | Measured as h*nmol/L | From pre-dose to after dosing on day 132 |
| Phase B: The maximum plasma concentration of NNC0487-0111 after the last dose | Measured as nmol/L | From pre-dose to after dosing on day 132 |
| Phase B: The time to maximum observed plasma concentration of NNC0487-0111 after the last dose | Measured as hours | From pre-dose to after dosing on day 132 |
| Phase B:The terminal half-life of NNC0487-0111 after the last dose | Measured as hours | From pre-dose on day 132 until completion of the end of study visit (day 153) |
| Number of treatment emergent adverse events (TEAE) | Measured as number of events | From time of trial product administration (Visit 2, day 1) until completion of the end of study visit (day 153) |
| 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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