Recent Updates
Recently added Catalysts

NNC0113-6856

Phase 1

Type 2 Diabetes | Small molecule | Metabolic |Novo Nordisk A/S|Trials Updated: Dec 31, 2025

NNC0113-6856 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Aug 2022

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment70

FDA Designations

No designations recorded

NNC0113-6856 clinical trials

NNC0113-6856 · 1 trial · 2 indications

Phase 1 1
NCT05521256A Research Study of a New Medicine NNC0113-6856 in Healthy MalesHealthy Volunteers
COMPLETED70 Analytics
PHASE1COMPLETED
A Research Study of a New Medicine NNC0113-6856 in Healthy Males
Healthy VolunteersUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of adverse events
From time of dosing (day 1) until completion of the follow-up visit (Day 42)

Measured as number of events.

Secondary Endpoints

For oral cohorts- AUC0-tz,sema,single dose (SD): Area under the semaglutide plasma concentration-time curve from time 0 to tz after a single dose, where tz is the time of last quantifiable concentration
From pre-dose (day 1) to completion of follow-up visit (Day 42)
For oral cohorts- AUC0-infinity (∞),sema,SD: Area under the semaglutide plasma concentration-time curve from time 0 to infinity after a single dose
From pre-dose (day 1) to completion of follow-up visit (Day 42)
For oral cohorts- Cmax,sema,SD: Maximum observed plasma concentration of semaglutide after a single dose
From pre-dose (day 1) to completion of follow-up visit (day 42)
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
NNC0113-6856 (Oral Cohort)EXPERIMENTALParticipants will receive single oral dose of NNC0113-6856 tablets in dose escalated manner.
PlaceboPLACEBO_COMPARATORParticipants will receive single oral dose of placebo (NNC0113-6856) tablets in dose escalated manner.
NNC0113-6856 (i.v. Cohort)EXPERIMENTALParticipants will receive single dose of 1.5 milligrams (mg) NNC0113-6856 intravenously (i.v.).

Interventions

NameTypeDescription
NNC0113-6856DRUGParticipants will receive NN0113-6856 orally or intravenously.
PlaceboDRUGParticipants will receive matching placebo of NNC0113-6856 for each of the oral cohorts.
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Male. * Aged 18-55 years (both inclusive) at the time of signing informed consent. * Body mass index between 20.0 and 27.0 kilogram per meter square (kg/m\^2)(both inclusive). Exclusion Criteria: * Glycated haemoglobin (HbA1c) greater than or equal to (\>=) 6.5 percent (%) (...

Countries:Germany
Unlock Eligibility Criteria

Frequently asked questions about NNC0113-6856

What is NNC0113-6856?

NNC0113-6856 is an investigational small molecule medicine being developed by Novo Nordisk for Type 2 Diabetes. It is in Phase 1 clinical development and has been studied in a single completed trial conducted in Germany. It is not an approved therapy.

What is NNC0113-6856 used for in Type 2 Diabetes?

NNC0113-6856 is being developed as a treatment for Type 2 Diabetes. The completed Phase 1 study enrolled healthy male volunteers and listed Type 2 Diabetes among its conditions. The program remains in early clinical development, so the drug is not available as a prescribed treatment.

Who makes NNC0113-6856?

NNC0113-6856 is developed by Novo Nordisk A/S, which trades under the ticker NVO. Novo Nordisk is the sponsor of the Phase 1 study of the compound. No partner or licensing arrangement for this asset is disclosed.

What phase is NNC0113-6856 in?

NNC0113-6856 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. The compound is investigational and has not been approved by the FDA or any other regulator based on the available information.

What clinical trials is NNC0113-6856 in?

NNC0113-6856 has been evaluated in one completed Phase 1 trial, NCT05521256, titled A Research Study of a New Medicine NNC0113-6856 in Healthy Males. The trial enrolled 70 participants in Germany, was randomized, double blind, and placebo controlled, and included only males aged 18 years and older.

Is NNC0113-6856 a small molecule drug?

Yes, NNC0113-6856 is a small molecule. It is being developed by Novo Nordisk as an oral-style small molecule candidate for Type 2 Diabetes, and it has completed one Phase 1 trial in healthy male volunteers. No later-stage trials are currently active.