Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NNC0385-0434 · 3 trials · 5 indications
h\*nmol/L
Count of events
| 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 being developed by Novo Nordisk for cardiovascular conditions, including elevated cholesterol and established atherosclerotic cardiovascular disease (ASCVD) or ASCVD risk. It has been studied in healthy volunteers and people with high cholesterol levels.
NNC0385-0434 is being developed by Novo Nordisk A/S, a pharmaceutical company traded on the NYSE under the ticker NVO. The drug is currently in Phase 1 clinical development.
NNC0385-0434 is in Phase 1 clinical development. All three clinical trials listed for the drug are Phase 1 studies and have been completed. The drug is investigational and has not been approved by regulatory authorities.
NNC0385-0434 has been studied in three completed Phase 1 trials: NCT04058834 in the UK, NCT05003440 in Japan, and NCT05091073 in Germany. These trials enrolled healthy volunteers and participants with high cholesterol or ASCVD risk, with a total enrollment of 75 participants.
NNC0385-0434 appears in clinical trial NCT05091073 under the name NN0385-0434, suggesting the two names refer to the same drug. The other two trials use the name NNC0385-0434.