Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NNC0363-1063 · 2 trials · 1 indication
Measured in milligrams per kilogram (mg/kg).
Measured in number of events.
Measured in millilitre per hour\*kilogram (mL/\[h\*kg\]).
Measured in hours\*millimoles per litre (h\*mmol/L).
| Arm | Type | Description |
|---|---|---|
| Sequence 1 | EXPERIMENTAL | Participants will receive NNC0363-1063 co-administered with and without non-glucose carbohydrate in treatment period 1 and treatment period 2. |
| Sequence 2 | EXPERIMENTAL | Participants will receive NNC0363-1063 co-administered with and without non-glucose carbohydrate in treatment period 1 and treatment period 2. |
| Sequence 3 | EXPERIMENTAL | Participants will receive NNC0363-1063 co-administered with and without non-glucose carbohydrate in treatment period 1 and treatment period 2. |
| Sequence 4 | EXPERIMENTAL | Participants will receive NNC0363-1063 co-administered with and without non-glucose carbohydrate in treatment period 1 and treatment period 2. |
| Part 1A: SAD: NNC0363-1063 | EXPERIMENTAL | Participants will receive single dose of NNC0363-1063 subcutaneously. |
| Part 1A: SAD: Placebo | PLACEBO_COMPARATOR | Participants will receive NNC0363-1063 matching placebo subcutaneously. |
| Part 1B: SAD: NNC0363-1063 | EXPERIMENTAL | Participants will receive NNC0363-1063 subcutaneously. |
| Part 1B: SAD: Insulin degludec | ACTIVE_COMPARATOR | Participants will receive insulin degludec subcutaneously. |
| Part 2: PoP: NNC0363-1063 | EXPERIMENTAL | Participants will receive NNC0363-1063 subcutaneously. |
| Part 3 Meal test: NNC0363-1063 | EXPERIMENTAL | Participants will receive NNC0363-1063 subcutaneously. |
| Part 3 Meal test: Insulin detemir | ACTIVE_COMPARATOR | Participants will receive insulin detemir subcutaneously. |
| Name | Type | Description |
|---|---|---|
| NNC0363-1063 | DRUG | NNC0363-1063 will be administered subcutaneously. |
| Placebo | DRUG | Placebo will be administered subcutaneously. |
| Insulin degludec | DRUG | Insulin degludec will be administered subcutaneously. |
| Insulin detemir | DRUG | Insulin detemir will be administered subcutaneously. |
Inclusion Criteria: * Male or female participant (sex at birth) of non-child bearing potential. Non-child bearing potential being defined as surgically sterilised (i.e., documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or being postmenopausal (defined as no menses for 12 ...
NNC0363-1063 is an investigational small molecule being developed for the treatment of Type 1 Diabetes Mellitus. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and remains under investigation for safety and efficacy.
NNC0363-1063 is being developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker NVO. The company is conducting clinical trials to evaluate the drug's safety and tolerability in participants with Type 1 Diabetes.
NNC0363-1063 is in Phase 1 clinical development. Two Phase 1 trials have been completed, both in Germany, with a total enrollment of 153 participants. The drug is investigational and has not received regulatory approval for any use.
NNC0363-1063 has been studied in two completed Phase 1 trials. NCT06685185 enrolled 117 participants, including healthy volunteers and those with Type 1 Diabetes. NCT07305805 enrolled 36 participants with Type 1 Diabetes. Both trials were conducted in Germany and are now complete.
NNC0363-1063 is a small molecule being investigated for Type 1 Diabetes Mellitus. Its specific molecular target has not been disclosed in available information, so its mechanism of action is not publicly described. The drug is in early-stage clinical testing to evaluate its effects.