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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1317-2736 | Other Identifier | World Health Organization (WHO) |
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This study tests how well different doses of the medicine NNC0662-0419 help people living with overweight or obesity. The purpose of the study is to find out if NNC0662-0419 is safe and effective for treating people living with overweight or obesity. There are 2 study treatments in this study, participants will get either NNC0662-0419, the treatment being tested or placebo, a treatment that has no active medicine in it. NNC0662-0419 is a new medicine which cannot be pre-scribed by doctors but has previously been tested in humans.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC0662-0419 | Experimental | Participants will be randomized to receive NNC0662-0419 subcutaneously (s.c.). The study will be conducted in 3 parts. Part A: Multiple ascending dose (MAD), Part B: Dose range finding (DFR) and Part C (2-week escalation). |
|
| Placebo | Placebo Comparator | Participant will be randomized to receive placebo in: The study will be conducted in 3 parts. Part A: Multiple ascending dose (MAD), Part B: Dose range finding (DFR) and Part C (2-week escalation). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0662-0419 | Drug | NNC0662-0419 will be administered subcutaneously. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Number of treatment-emergent adverse events (TEAE) | Measured as number of events. | From baseline (week 0) to end of study (up to week 44) |
| Part B: Relative change in body weight | Measured as percentage (%). | From baseline (week 0) to end of treatment (week 36) |
| Part C: Occurrence of premature treatment discontinuation (Yes/No) | Measured as count of participants. | At end of treatment (week 24) |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Relative change in body weight | Measured as percentage (%). | From baseline (week 0) to end of treatment (up to week 40) |
| Part A: Change in body weight | Measured in kilograms (kg). |
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Inclusion criteria
Male or female (sex at birth).
Age at the time of signing the informed consent:
Body Mass Index (BMI) at screening (overweight should be due to excess adipose tissue, as judged by the investigator):
For Part A: 27.0-39.9 kilogram per square meter(kg/m^2) (both inclusive)
For Part B and Part C:
Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as-judged by the investigator.
Willingness to obtain a high weight loss (greater than [>] 25 percent [%]).
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, Phoenix | Tempe | Arizona | 85283 | United States | ||
| Celerion, Lincoln |
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 |
| Drug |
Placebo matched to NNC0662-0419 will be administered subcutaneously. |
|
| From baseline (week 0) to end of treatment (up to week 40) |
| Part A: AUC; the area under the NNC0662-0419 plasma concentration-time curve | Measured in hours*nanomole per litre (h*nmol/L). | From pre-dose on day 1 to completion of the end of study visit (up to week 44) |
| Part A: Cmax; the maximum plasma concentration of NNC0662-0419 | Measured in nanomole per litre (nmol/L). | From pre-dose on day 1 to completion of the end of study visit (up to week 44) |
| Part B: Change in body weight | Measured in kg. | From baseline (week 0) to end of treatment (week 36) |
| Part B: Body weight reduction greater than or equal to (≥) 5% (Yes/No) | Measured as count of participants. | From baseline (week 0) to end of treatment (week 36) |
| Part B: Body weight reduction ≥ 10% (Yes/No) | Measured as count of participants. | From baseline (week 0) to end of treatment (week 36) |
| Part B: Body weight reduction ≥ 15% (Yes/No) | Measured as count of participants. | From baseline (week 0) to end of treatment (week 36) |
| Part B: Body weight reduction ≥ 20% (Yes/No) | Measured as count of participants. | From baseline (week 0) to end of treatment (week 36) |
| Part B: Body weight reduction ≥ 25% (Yes/No) | Measured as count of participants. | From baseline (week 0) to end of treatment (week 36) |
| Part B: Number of treatment emergent adverse events (TEAE) | Measured as number of events. | From baseline (week 0) to end of study (week 39) |
| Part C: Number of treatment emergent adverse events (TEAE) | Measured as number of events. | From baseline (week 0) to end of study (week 27) |
| Lincoln |
| Nebraska |
| 68502 |
| United States |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |