Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NNC0114-0006 · 4 trials · 5 indications
Area under the concentration-time curve, from 0 to 4 hours (AUC0-4h) of a mixed meal tolerance test (MMTT) stimulated C-peptide at week 54 is presented as ratio to baseline. AUC of C-peptide was measured as Nano moles\*hour per liter (nmol\*h/L).
| Arm | Type | Description |
|---|---|---|
| NNC0114-0006 + Liraglutide | EXPERIMENTAL | - |
| NNC0114-0006 + Placebo | EXPERIMENTAL | - |
| Liraglutide + Placebo | ACTIVE_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | - |
| NNC0114-0006 | EXPERIMENTAL | - |
| Active | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| NNC0114-0006 | DRUG | NNC0114-0006 12 mg/kg administered i.v (intravenously) every 6 weeks. Subjects will continue their pre-trial insulin treatment |
| liraglutide | DRUG | Liraglutide 1.8 mg administered s.c. (subcutaneously) daily. Subjects will continue their pre-trial insulin treatment |
| placebo | DRUG | Placebo administered s.c (subcutaneously) or i.v ( intravenously). Subjects will continue their pre-trial insulin treatment |
Inclusion Criteria: * Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial * T1DM (type 1 diabetes mellitus) (as diagnosed clinically) for not...
NNC0114-0006 is an investigational small molecule developed by Novo Nordisk A/S. It has been studied in Phase 2 clinical trials for type 1 diabetes and in inflammatory conditions including Crohn's disease and rheumatoid arthritis. It is not an approved medicine and remains in clinical development.
NNC0114-0006 targets interleukin-21, or IL21. It is classified as a binding agent directed at this cytokine target. By binding IL21, the compound is designed to interfere with IL21-mediated immune signaling, which is the rationale behind studying it in autoimmune and inflammatory conditions as well as type 1 diabetes.
NNC0114-0006 is developed by Novo Nordisk A/S, which trades under the ticker NVO. Novo Nordisk sponsored the clinical program for the compound, including the Phase 1 and Phase 2 trials conducted in type 1 diabetes, Crohn's disease, and rheumatoid arthritis.
NNC0114-0006 has completed Phase 2 testing. Three Phase 2 trials and one Phase 1 trial have been completed, and no trials are currently active. The compound is investigational and has not been approved for any indication.
Completed trials include NCT02443155, a Phase 2 proof-of-principle study in newly diagnosed type 1 diabetes with 308 participants; NCT01751152, a Phase 2 trial in active Crohn's disease; NCT01647451, a Phase 2 trial in active rheumatoid arthritis; and NCT01565408, a Phase 1 safety and tolerability study in rheumatoid arthritis.
NNC0114-0006 was studied in newly diagnosed type 1 diabetes to assess preservation of beta-cell function. The Phase 2 trial NCT02443155 evaluated the compound, both alone and together with liraglutide, in 308 adults across 18 countries. The study was randomized, double-blind, and placebo-controlled, and it has been completed.