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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1231-4690 | Other Identifier | World Health Organization (WHO) | |
| 2019-001746-18 | Registry Identifier | European Medicines Agency (EudraCT) |
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In this study, there are two study medicines: NNC0385-0434 (the new medicine being tested) and placebo (a 'dummy' medicine). Participants will only get one of these medicines - which one is decided by chance. The study medicine for each person is chosen by a computer. A dummy medicine (placebo) looks like the study medicine but has no effect on the body. The dummy medicine needs to be used in the study to find out if the study medicine works as expected. The dose of the study medicines that participants receive will depend on which group they get into. The study has 4 groups of 8-15 participants in each. Each group will get a different dose of NNC0385-0434 or placebo. Participants and the study doctor will not know which of the study medicine/dose participants will get. However, if a participant's safety is at risk, the study doctor will be told in order to decide the future treatment. NNC0385-0434 may help to clear cholesterol from the blood. When there is less cholesterol circulating in the blood over a long period of time, then there is less risk of arteries (blood vessels) being clogged or developing diseases of the heart and blood vessels. Each participant will get one injection under the skin and will be in the study for about 4 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC0385-0434 | Experimental | Healthy volunteers will be randomised to one of three cohorts. In each cohort of 8 participants, 6 will receive active drug and 2 will receive placebo. Following safety observation, patients with hypercholesterolaemia will enter a fourth cohort. There will be 15 participants in this cohort. |
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| Placebo (NNC0385-0434) | Placebo Comparator | Healthy volunteers will be randomised to one of three cohorts. In each cohort of 8 participants, 6 will receive active drug and 2 will receive placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0385-0434 | Drug | Healthy volunteers and patients will receive one injection s.c. (subcutaneously, under the skin) |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment emergent adverse events (TEAEs) | Count | From time of first dosing (Day 1) to completion of the post-treatment follow-up visit (Day 70) |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-∞,0434,SD; the area under the NNC0385-0434 plasma concentration-time curve from time 0 to infinity after a single dose of s.c. NNC0385-0434 | nmol/L*h | From day of dose (Day 1) until end of treatment (Day 70) |
| Cmax,0434,SD; the maximum plasma concentration of NNC0385-0434 after a single dose of s.c. NNC0385-0434 |
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Inclusion Criteria:
Healthy volunteers:
Patients with hypercholesterolaemia:
Exclusion Criteria:
Healthy volunteers:
Patients with hypercholesterolaemia:
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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 | Harrow | HA1 3UJ | United Kingdom |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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Four (4) cohorts are planned. In 3 cohorts, healthy subjects will be randomised in a 3:1 manner to receive either: 1) NNC0385-0434 or 2) Placebo (NNC0385-0434). Each cohort will last 10 weeks and there will be 3 weeks between cohorts. Following safety observation, a fourth cohort will be initiated with patients with hypercholesterolaemia. Patients will be randomised in a 2:1 manner to receive either: 1) NNC0385-0434 or 2) Placebo (NNC0385-0434).
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Sponsor staff involved in the clinical trial is masked according to company standard procedures
| Placebo (NNC0385-0434) | Drug | Healthy volunteers will receive one injection s.c. |
|
nmol/L |
| From day of dose (Day 1) until end of treatment (Day 70) |
| t½,0434,SD; the terminal half-life of NNC0385-0434 after a single dose of s.c. NNC0385-0434 | h | From time of first dosing (Day 1) to completion of the post-treatment follow-up visit (Day 70) |
| tmax,0434,SD; the time to maximum plasma concentration of NNC0385-0434 after a single dose of s.c. NNC0385-0434 | h | From time of first dosing (Day 1) to completion of the post-treatment follow-up visit (Day 70) |
| Change in fasting LDL-C levels after a single dose of s.c. NNC0385-0434 | Ratio to pre-dose | Day 1, day 70 |
| D009750 |
| Nutritional and Metabolic Diseases |