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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1212-3615 | Other Identifier | World Health Organization (WHO) |
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The study is looking at possible new medicines for weight control in people with high body weight. The study looks at how the new medicines work in the body. The study consists of two parts. If participants take part in Part 1, they will either get a single dose of NNC0165-1875 or a "dummy" medicine (placebo). If participants take part in Part 2, they will either get a single dose of NNC0165-1875 or "dummy" medicine and also a single dose of semaglutide. Which treatment participants get is decided by chance. For Part 1 participants will get 1 injection. For Part 2 participants will get 2 injections. 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 9 weeks. Participants will have 7 visits to the clinic with the study doctor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC0165-1875 | Experimental | Participants will receive NNC0165-1875 alone in cohorts 1-5 (part 1) and NNC0165-1875 along with semaglutide in cohorts 6-11 (part 2). |
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| Placebo | Placebo Comparator | Participants will receive placebo alone in cohorts 1-5 (part 1) and placebo along with semaglutide in cohorts 6-11 (part 2). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0165-1875 | Drug | Participants will receive a single dose of subcutaneous (s.c.) NNC0165-1875 injection. The planned doses of NNC0165-1875 are as following: cohort 1 and 7: 0.1 mg, cohort 2 and 8: 0.3 mg, cohort 3 and 9: 0.6 mg, cohort 4 and 10: 1.2 mg, cohort 5 and 11: 2.4 mg and cohort 6: 0.03 mg. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment emergent adverse events (TEAEs) | Count of adverse events. | Day 1-36 |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-∞,1875,SD; the area under the NNC0165-1875 plasma concentration-time curve from time 0 to infinity after a single s.c. dose | Calculated based on plasma NNC0165-1875 measured (nmol*h/L) in blood. | 1-36 days |
| Cmax,1875,SD; the maximum plasma concentration of NNC0165-1875 after a single s.c. dose |
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Inclusion Criteria:
Exclusion Criteria:
- Male of reproductive age who or whose partner(s) is not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice)
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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 |
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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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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In total, 11 cohorts are planned. Five cohorts in Part 1 (cohort 1-5), and 6 cohorts (cohort 6-11) in Part 2. Each cohort will contain 8 participants. The first 2 participants will be randomised so one participant will receive active (Part 1: NNC0165-1875; Part 2: NNC0165-1875 and semaglutide) while the other receive placebo (Part 1: placebo; Part 2: placebo and semaglutide) treatment. The participants will remain in-house for a 5 days safety observation period. The remaining 6 subjects will be dosed at least after 96 hours.
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Sponsor staff involved in the clinical trial is masked according to company standard procedures.
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| Placebo (NNC0165-1875) | Drug | Participants will receive a single dose of s.c. placebo injection. |
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| Semaglutide | Drug | Participants will receive a single dose of s.c. semaglutide 0.25 mg injection. |
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Calculated based on plasma NNC0165-1875 measured (nmol/L) in blood. |
| 1-36 days |
| AUC0-∞,sema,SD; the area under the semaglutide plasma concentration-time curve from time 0 to infinity after a single s.c. dose | Calculated based on plasma semaglutide measured (nmol*h/L) in blood. | 1-36 days |
| Cmax,sema,SD; the maximum plasma concentration of semaglutide after a single s.c. dose | Calculated based on plasma semaglutide measured (nmol/L) in blood. | 1-36 days |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |