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NNC0385-0434 · 3 trials · 5 indications
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| Arm | Type | Description |
|---|---|---|
| Fed group | EXPERIMENTAL | Fed dosing conditions |
| Fasting group | EXPERIMENTAL | Fasting dosing conditions |
| Reference group | ACTIVE_COMPARATOR | Reference dosing conditions |
| NNC0385-0434 15 mg | EXPERIMENTAL | 15 mg oral NNC0385-0434 will be administered once-daily over 10 consecutive days |
| Placebo (NNC0385-0434 15 mg) | PLACEBO_COMPARATOR | Oral placebo will be administered once-daily over 10 consecutive days |
| NNC0385-0434 40 mg | EXPERIMENTAL | 40 mg oral NNC0385-0434 will be administered once-daily over 10 consecutive days |
| Placebo (NNC0385-0434 40 mg) | PLACEBO_COMPARATOR | Oral placebo will be administered once-daily over 10 consecutive days |
| NNC0385-0434 100 mg | EXPERIMENTAL | 100 mg oral NNC0385-0434 will be administered once-daily over 10 consecutive days |
| Placebo (NNC0385-0434 100 mg) | PLACEBO_COMPARATOR | Oral placebo will be administered once-daily over 10 consecutive days |
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| NNC0385-0434 | DRUG | All participants will be dosed with 40 mg oral NNC0385-0434 once-daily for 10 consecutive days |
| Placebo | DRUG | Participants will get 1 tablet (oral use) of placebo per day for 10 days |
| Placebo (NNC0385-0434) | DRUG | Healthy volunteers will receive one injection s.c. |
Inclusion Criteria: * Male. * Aged 18 to 55 (both inclusive). * Considered to be generally healthy based on medical history, physical examination, and the results of vital signs, ECG and clinical laboratory tests performed during the screening visit, as judged by the investigator. * Body weight min...
NNC0385-0434 is an investigational small molecule medicine being developed by Novo Nordisk for cardiovascular conditions. It is being studied in people with established atherosclerotic cardiovascular disease or ASCVD risk, and in people with hypercholesterolaemia, which is high cholesterol. It has completed Phase 1 clinical testing and is not yet an approved treatment.
NNC0385-0434 is being studied for atherosclerotic cardiovascular disease, including established ASCVD or ASCVD risk, and for hypercholesterolaemia. The completed Phase 1 trials enrolled healthy volunteers as well as participants with elevated cholesterol. Because it remains investigational, NNC0385-0434 is not currently available as a prescribed treatment for any of these conditions.
NNC0385-0434 is developed by Novo Nordisk A/S, the Danish pharmaceutical company whose shares trade under the ticker NVO. Novo Nordisk sponsored the Phase 1 clinical studies of the compound, which were run in Germany, Japan and the United Kingdom. The drug remains an investigational asset in the company's cardiovascular pipeline.
NNC0385-0434 has completed Phase 1 clinical development. Three Phase 1 studies have finished, and no active trials of the compound are currently listed. The trials were randomized, double-blind and placebo-controlled, and enrolled healthy volunteers along with participants who had elevated cholesterol. NNC0385-0434 is investigational and has not been approved for marketing.
Three completed Phase 1 trials have studied NNC0385-0434. NCT05091073 examined the effect of food intake on how the medicine behaves in the body of healthy participants in Germany. NCT05003440 looked at how it works in healthy Japanese men in Japan. NCT04058834 investigated how it is tolerated in people with or without high cholesterol levels in the United Kingdom.
No. NNC0385-0434 is an investigational drug that has completed Phase 1 clinical development and has not been approved by the FDA or any other regulator. The completed studies were early-stage trials assessing tolerability and how the medicine behaves in the body, not large outcome trials. Further clinical development would be needed before any regulatory review.