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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1193-7228 | Other Identifier | World Health Organization (WHO) |
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This study looks at a new study medicine for weight control in people with overweight or obesity. The aim of this study is to see if the study medicine is safe for people to take. The study also looks at how fast the body removes the study medicine. The participants will either get NNC0194-0499 (the study medicine) or placebo (a formula that looks like the medicine but does not have active ingredients). Which treatment the participants get is decided by chance. The participants will get 1 or more injections into the skin of stomach area once each week for 12 weeks. The study will last for about 4 to 5 months. The participants will have 18 visits to the clinic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC0194-0499 | Experimental | Participants will receive increasing doses of NNC0194-0499. The treatment period from first treatment (Day 1) to end of the treatment (Day 85) will be 12 weeks. |
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| Placebo | Placebo Comparator | Participants will receive NNC0194-0499 matched placebo. The treatment period from first treatment (Day 1) to end of the treatment (Day 85) will be 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0194-0499 | Drug | Participants will receive NNC0194-0499 (s.c., in a lifted fold of the abdominal skin) injection once weekly at increasing doses of 3.0 mg, 9.0 mg, 27 mg, 60 mg, or 120 mg. Each participant will only be given one dose level. Dose escalation will proceed to the next planned dose level if there are no safety concerns raised by the investigator or by the trial safety group. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment emergent adverse events (TEAEs) | count of events | From first administration of NNC0194-0499 (Day 1) to follow-up (Day 112) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in heart rate | measured in beats per minute | Baseline (Day 1), Follow-up (Day 112) |
| Change in biochemistry | Parameters: Calcium (total), Chloride, Magnesium, Phosphate (inorganic), Potassium, Sodium, Urea (blood urea nitrogen, BUN), Uric acid, Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Amylase, Aspartate aminotransferase (AST), Creatinine kinase (CK, total), Gamma glutamyltransferase (GGT), Lactase dehydrogenase, Lipase, Albumin, Bicarbonate, Bilirubin (total), Creatinine, High sensitivity C-reactive protein (hsCRP) and Total protein in SI units |
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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 | San Antonio | Texas | 78209 | United States |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D001835 | Body Weight |
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Sponsor staff involved in the clinical trial is masked according to company standard procedures
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| Placebo | Drug | Participants will receive once weekly injections of NNC0194-0499 matched placebo. |
|
| Baseline (Day -1), Follow-up (Day 112) |
| Change in haematology | Parameters: Erythrocytes, Reticulocytes, Thrombocytes, Leucocytes (total), Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Haemoglobin, Haematocrit, Mean corpuscular volume (MCV) and Mean corpuscular haemoglobin concentration (MCHC) in SI units | Baseline (Day -1), Follow-up (Day 112) |
| Change in fibrinogen | measured in g/L | Baseline (Day -1), Follow-up (Day 112) |
| Change in prothrombin time read as international normalised ratio (INR) | Baseline (Day -1), Follow-up (Day 112) |
| Change in activated partial thromboplastin time (APTT) | measured in seconds | Baseline (Day -1), Follow-up (Day 112) |
| Changes in electrocardiogram (ECG) | Parameters: RR interval, PR interval, QRS interval, QT interval and QTcF interval in SI units | Baseline (Day 1), Follow-up (Day 112) |
| Number of injection site reactions | count of injection site reactions | From baseline (Day 1) to follow-up (Day 112) |
| Occurrence of anti-NNC0194-0499 antibodies | From baseline (Day 1) to follow-up (Day 112) |
| t½,SS: the terminal serum half-life of NNC0194-0499 at steady state | Calculated based on serum concentrations of NNC0194-0499 | From last dose (Day 78, pre-dose) until the follow-up (Day 112) |
| Cmax,SS: the maximum concentration of NNC0194-0499 in serum at steady state | Calculated based on serum concentrations of NNC0194-0499 | From last dose (Day 78, pre-dose) until the follow-up (Day 112) |
| tmax,SS: the time to maximum concentration of NNC0194-0499 in serum at steady state | Calculated based on serum concentrations of NNC0194-0499 | From last dose (Day 78, pre-dose) until the follow-up (Day 112) |
| CL/F SS: the apparent total serum clearance of NNC0194-0499 at steady state | Calculated based on serum concentrations of NNC0194-0499 | From last dose (Day 78, pre-dose) until the follow-up (Day 112) |
| Change in systolic blood pressure | measured in mmHg | Baseline (Day 1), Follow-up (Day 112) |
| Change in diastolic blood pressure | measured in mmHg | Baseline (Day 1), Follow-up (Day 112) |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |