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NNC 0113-0987 · 5 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| NNC0113-0987 | EXPERIMENTAL | - |
| Oral B (DC) | EXPERIMENTAL | Escalation design. Planned end dose level is 5 mg alternative dosing condition (fasting for 30 minutes post-dosing) |
| Oral D | EXPERIMENTAL | Escalation design. Planned end dose level is 20 mg standard dosing condition (fasting for 120 minutes post-dosing) |
| Oral C | EXPERIMENTAL | Escalation design. Planned end dose level is 10 mg standard dosing condition (fasting for 120 minutes post-dosing) |
| Oral B | EXPERIMENTAL | Escalation design. Planned end dose level is 5 mg standard dosing condition (fasting for 120 minutes post-dosing) |
| Oral A | EXPERIMENTAL | Escalation design. Planned end dose level is 2.5 mg standard dosing condition (fasting for 120 minutes post-dosing) |
| DC (dosing condition) | EXPERIMENTAL | Escalation design. |
| Placebo | PLACEBO_COMPARATOR | - |
| NNC 0113-0987 (gastro) | EXPERIMENTAL | - |
| NNC 0113-987 (coated) | EXPERIMENTAL | - |
| NNC 0113-987 (i.v) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| NNC0113-0987 | DRUG | For oral administration. All subjects will be treated for 10 consecutive days with five days on 5 mg NNC0113-0987 followed by five days on 10 mg NNC0113-0987. Dose escalation is chosen to increase gastrointestinal tolerability. |
| placebo | DRUG | Tablets for one-daily oral administration. |
| oral NNC 0113-0987 | DRUG | Subjects will be randomised to receive a single dose of NNC 0113-0987 at escalating dose levels. Progression to next dose will be based on safety evaluation. |
| I.v. NNC 0113-0987 | DRUG | Subjects will be administered a single i.v (into the vein) dose. The treatment with NNC 0113-0987 will be open-label, and will not be randomised. |
| oral placebo | DRUG | Subjects will be randomised to receive a single dose of placebo. |
Inclusion Criteria: * Male aged 18 between 55 years (both inclusive) at the time of signing informed consent * Good general health based on medical history, physical examination, and results of vital signs, electrocardiogram and laboratory safety tests performed during the screening visit, as judge...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| FibroBiologics, Inc. | FBLG | 1 | PHASE1 | Undisclosed |
| MiMedx Group, Inc. | MDXG | 2 | N/A | Undisclosed |
| Integra LifeSciences Holdings Corporation | IART | 1 | N/A | Undisclosed |
| Organogenesis Holdings, Inc. Class A | ORGO | 1 | N/A | Undisclosed |
| Healthcare Services Group, Inc. | HCSG | 1 | N/A | Undisclosed |
NNC 0113-0987 is an investigational small molecule being developed for diabetes, including type 2 diabetes. It is in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied for its safety, tolerability, and pharmacokinetics in clinical trials.
NNC 0113-0987 is being developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker NVO. The company is conducting Phase 1 clinical trials to evaluate the drug's safety and pharmacokinetic profile in healthy subjects and patients with diabetes.
NNC 0113-0987 is in Phase 1 clinical development. All five clinical trials for the drug have been completed, with no active trials currently ongoing. The drug remains investigational and has not received FDA approval or any other regulatory approval for use in patients.
NNC 0113-0987 has been studied in five completed Phase 1 trials, including NCT01405261, NCT01690169, NCT01978613, and NCT02094521. These trials evaluated safety, tolerability, and pharmacokinetics of single and multiple doses in healthy subjects, with some studies involving oral formulations and dosing conditions.
Yes, NNC 0113-0987 and NNC0113-0987 refer to the same drug. The name is written with and without a space in clinical trial records. Both forms are used interchangeably in the literature and trial registrations for this investigational diabetes treatment.