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NNC0113-6856

Phase 1

Healthy Participants | Small molecule | Other |Novo Nordisk A/S|Last Updated: Dec 31, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment170

FDA Designations

No designations recorded

Clinical trial landscape

NNC0113-6856 · 2 trials · 3 indications

Phase 1 2
NCT06069895Investigation of Safety, Tolerability and Pharmacokinetics of Multiple Doses of NNC0113-6856 in Healthy Participants, Including a Subset of Healthy Japanese ParticipantsHealthy Participants
COMPLETED170 Analytics
NCT05521256A Research Study of a New Medicine NNC0113-6856 in Healthy MalesHealthy Volunteers
COMPLETED70 Analytics
PHASE1COMPLETED
Investigation of Safety, Tolerability and Pharmacokinetics of Multiple Doses of NNC0113-6856 in Healthy Participants, Including a Subset of Healthy Japanese Participants
Healthy ParticipantsUnlock trial 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 (AEs)
From time of first dosing (day 1) until completion of the follow-up visit (day 148)

Measured as number of events.

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

Part 1 Multiple ascending dose (MAD): AUCτ,sema,SS: area under the semaglutide plasma concentration-time curve during a dosing interval τ at steady state
From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
Part 1 (MAD): Cmax,sema,SS: maximum observed plasma concentration of semaglutide at steady state
From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
Part 1 (MAD): AUCτ,6856,SS: area under the NNC0113-6856 plasma concentration-time curve during a dosing interval τ at steady state
From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
NNC0113-6856EXPERIMENTALParticipants will receive NNC0113-6856 oral tablets.
PlaceboEXPERIMENTALParticipants will receive NNC0113-6856 matching placebo oral tablets.
NNC0113-6856 (Oral Cohort)EXPERIMENTALParticipants will receive single oral dose of 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
NNC0113-6856DRUGNNC0113-6856 will be administered as oral tablets.
PlaceboDRUGNNC0113-6856 matching placebo will be administered as oral tablets.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male or female. * Age 18-55 years (both inclusive) at the time of signing the informed consent. * Body mass index (BMI) between 21.0 and 29.9 kilograms per meter square (kg/m\^2) (both inclusive) at screening. Additional for healthy Japanese participants: * First generation ...

Countries:Germany
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Frequently asked questions about NNC0113-6856

What is NNC0113-6856?

NNC0113-6856 is an investigational small molecule being developed by Novo Nordisk A/S. It is currently in Phase 1 clinical development for use in healthy participants and healthy volunteers. The drug is being studied to assess its safety, tolerability, and pharmacokinetics.

What is NNC0113-6856 used for?

NNC0113-6856 is being studied for use in healthy participants and healthy volunteers. Clinical trials are evaluating its safety, tolerability, and pharmacokinetics in these populations. The drug is not yet approved and remains in early-stage clinical development.

Who makes NNC0113-6856?

NNC0113-6856 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 tolerability in healthy participants.

What phase is NNC0113-6856 in?

NNC0113-6856 is in Phase 1 clinical development. Two Phase 1 trials have been completed, with a total enrollment of 170 participants. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is NNC0113-6856 in?

NNC0113-6856 has been studied in two completed Phase 1 trials. NCT05521256 evaluated the drug in healthy males, and NCT06069895 investigated multiple doses in healthy participants, including a subset of healthy Japanese participants. Both trials were conducted in Germany.

Is NNC0113-6856 the same as any other drug?

NNC0113-6856 is the primary name for this investigational drug. No alternative names have been reported in clinical trial records. It is a small molecule being developed by Novo Nordisk A/S.