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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1191-5147 | Other Identifier | World Health Organization (WHO) |
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The study is investigating new medicines for weight control in people with high body weight. The study looks at how the study medicines work in the body. Participants will get semaglutide and either NNC0165-1562 or "dummy" medicine -which treatment participants get is decided by chance. Participants will get 2 injections per week for 5 months. A study nurse at the clinic will inject the medicine with a thin needle in a skin fold in the stomach. The study will last for about 7 months. Participants will have 27 visits to the clinic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC0165-1562 + Semaglutide | Experimental | Participants will receive NNC0165-1562 and semaglutide once weekly for 20 weeks. |
|
| Placebo (NNC0165-1562) + Semaglutide | Experimental | Participants will receive placebo (NNC0165-1562) and semaglutide once weekly for 20 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0165-1562 | Drug | Participants will receive NNC0165-1562 subcutaneous (s.c., under the skin) injection(s) once-weekly for 20 weeks. The dose will be escalated over 16 weeks to a final dose level that will be maintained for 4 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment emergent adverse events (TEAEs) | Count of adverse events. | Week 0-25 |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-168h,1562,SS; the area under the NNC0165-1562 plasma concentration-time curve from time 0 to 168 hours at steady state | Measured in nmol*h/L. Measured at hours 0, 4, 8, 16, 24, 36, 48, 60 and 168 starting on day 134. | Week 19 (day 134) to week 20 (day 141) |
| AUC0-168h,sema,SS; the area under the semaglutide plasma concentration time curve from 0 to 168 hours at steady state |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Reporting Anchor and Disclosure (1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Tempe | Arizona | 85283 | United States | ||
| Novo Nordisk Investigational Site |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
| D044343 | Overnutrition |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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Three (3) cohorts are planned. In each cohort subjects will be assigned to trial product. Subjects will be randomised in a 3:1 manner within cohorts to receive either:
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Sponsor staff involved in the clinical trial is masked according to company standard procedures.
| Semaglutide | Drug | Participants will receive semaglutide s.c. injection(s) once-weekly for 20 weeks. The dose will be escalated over 16 weeks to a final dose level that will be maintained for 4 weeks. |
|
| Placebo (NNC0165-1562) | Drug | Participants will receive placebo (NNC0165-1562) s.c. injection(s) once-weekly for 20 weeks. |
|
Measured in nmol*h/L. Measured at hours 0, 4, 8, 16, 24, 36, 48, 60 and 168 starting on day 134. |
| Week 19 (day 134) to week 20 (day 141) |
| Lincoln |
| Nebraska |
| 68502 |
| United States |
| D013568 |
| Pathological Conditions, Signs and Symptoms |