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Also known as oral NNC 0113-0987
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...
NNC 0113-0987 is an investigational oral small molecule developed by Novo Nordisk A/S for diabetes. It is a long acting GLP-1 analogue and has been studied in Phase 1 clinical trials in healthy male subjects. It is not an approved medicine and remains in clinical development.
NNC 0113-0987 is being developed for the treatment of diabetes, including type 2 diabetes mellitus. Its Phase 1 trials enrolled healthy male volunteers and listed diabetes among the study conditions. No approved use has been established, and the compound remains investigational.
NNC 0113-0987 is a GLP-1 analogue, so it is designed to act on the GLP-1 receptor pathway. It is described as a long acting oral small molecule. Trial titles refer to it as a GLP-1 analogue given in an oral formulation.
Novo Nordisk A/S develops NNC 0113-0987. The company trades on the New York Stock Exchange under the ticker NVO. Novo Nordisk sponsored the Phase 1 trials of the compound, which were run in the United Kingdom and Germany.
NNC 0113-0987 is in Phase 1. Five Phase 1 trials have been completed, with no active trials, and total enrollment across those studies was about 450 participants. The trials were randomized, double blind, and controlled.
Five completed Phase 1 trials have studied NNC 0113-0987: NCT02094521, NCT01978613, NCT01967589, NCT01690169, and one additional study. They examined safety, tolerability, pharmacokinetics, pharmacodynamics, and optimal oral dosing in healthy male subjects, mostly in the United Kingdom and Germany.
Yes. NNC 0113-0987, NNC0113-0987, and oral NNC 0113-0987 refer to the same investigational compound from Novo Nordisk. The oral form is the formulation studied in the Phase 1 trials, which evaluated dosing conditions for oral administration.