Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NNC 0123-0000-0338 · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| Dose levels 1-7 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| NNC 0123-0000-0338 | DRUG | Subjects will be randomised to receive a single dose of NNC 0123-0000-0338 (tablet), at 7 escalating dose levels. Progression to next dose level will be based on a safety evaluation. |
| placebo | DRUG | Subjects will receive a single dose of placebo (tablet), as a comparator to NNC 0123-0000-0338 at all dose levels. Placebo dose remains the same at all dose levels. |
| insulin glargine | DRUG | As an open label active comparator, a single dose of insulin glargine will be administered subcutaneously (under the skin), at all dose levels. Insulin glargine dose remains the same at all dose levels. |
Inclusion Criteria: * Male subject * Body mass index (BMI) between 18 and 28 kg/m\^2 (both inclusive) Exclusion Criteria: * Known or suspected hypersensitivity to trial products or related products * Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartb...
| 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 0123-0000-0338 is an investigational small molecule being developed for diabetes. It is in Phase 1 clinical development, with one completed trial in healthy subjects and people with diabetes. The drug is not approved and remains under investigation.
NNC 0123-0000-0338 is being developed by Novo Nordisk A/S, a biopharmaceutical company listed on the stock exchange under the ticker NVO. The company is conducting clinical trials to evaluate the safety of this investigational drug.
NNC 0123-0000-0338 is in Phase 1 clinical development. One Phase 1 trial has been completed, and the drug remains investigational. It has not been approved by regulatory authorities and is still being studied for safety.
NNC 0123-0000-0338 has one completed clinical trial, NCT01334034, titled "Safety of NNC 0123-0000-0338 in Healthy Subjects." This Phase 1 study enrolled 70 male participants in Germany, including healthy volunteers and individuals with diabetes.
No alternative names for NNC 0123-0000-0338 have been disclosed. The drug is identified solely by this code name in clinical trial records. It is a distinct investigational compound being developed by Novo Nordisk.