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NNC0113-2023

Phase 1

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Jan 10, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

NNC0113-2023 · 1 trial · 1 indication

Phase 1 1
NCT03617081First Research Study of the Possible New Medicine NNC0113-2023 in Healthy Men.Diabetes Mellitus, Type 2
COMPLETED40 Analytics
PHASE1COMPLETED
First Research Study of the Possible New Medicine NNC0113-2023 in Healthy Men.
Diabetes Mellitus, Type 2Unlock trial analytics

Study Endpoints

Primary Endpoints

Number of treatment emergent adverse events (TEAEs)
From time of dosing (day 1) until completion of the follow-up visit (day 43)

Count of events

Secondary Endpoints

AUC0-∞,2023,SD; the area under the NNC0113-2023 plasma concentration-time curve from time 0 to infinity after a single dose of oral NNC0113-2023
From baseline (day 1) to post treatment follow-up (day 43)
Cmax,2023,SD; the maximum plasma concentration of NNC0113-2023 after a single dose of oral NNC0113-2023
From baseline (day 1) to post treatment follow-up (day 43)
AUC0-24h,SNAC,SD; the area under the SNAC plasma concentration-time curve from time 0 to 24 hours after a single dose of oral NNC0113-2023
From baseline (day 1) to 24 hours after dosing
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
NNC0113-2023EXPERIMENTALParticipants will receive increasing doses of NNC0113-2023 on day 1. Each participant will receive only a single dose.
PlaceboPLACEBO_COMPARATORParticipants will receive placebo (NNC0113-2023)

Interventions

NameTypeDescription
NNC0113-2023DRUGParticipants will receive dose levels of 1 mg, 2 mg, 4 mg, 8 mg, 16 mg or 32 mg of NNC0113-2023 orally. Each participant will receive only one dose.
Placebo (NNC0113-2023)DRUGParticipants will receive NNC0174-0833 matched placebo orally.
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Eligibility Criteria

Age Range18 Years to 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male aged 18 - 45 years (both inclusive) at the time of signing informed consent. * Body mass index between 20.0 kg/m\^2 and 29.9 kg/m\^2 (both inclusive). * Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, ...

Countries:United States
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Frequently asked questions about NNC0113-2023

What is NNC0113-2023 used for in Diabetes Mellitus, Type 2?

NNC0113-2023 is an investigational small molecule being developed for the treatment of Diabetes Mellitus, Type 2. It is currently in Phase 1 clinical development, meaning it has not yet been approved and is still being studied for safety and tolerability in clinical trials.

Who makes NNC0113-2023?

NNC0113-2023 is being developed by Novo Nordisk A/S, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVO. The company is conducting clinical research to evaluate the drug's potential as a treatment for Type 2 diabetes.

What phase is NNC0113-2023 in?

NNC0113-2023 is in Phase 1 clinical development. It is an investigational drug, meaning it is not yet approved for use. The Phase 1 trial has been completed, and the drug is still in the early stages of clinical testing.

What clinical trials is NNC0113-2023 in?

NNC0113-2023 has one completed Phase 1 clinical trial registered as NCT03617081, titled "First Research Study of the Possible New Medicine NNC0113-2023 in Healthy Men." The trial enrolled 40 participants in the United States and was a randomized, double-blind, placebo-controlled study.

Is NNC0113-2023 the same as any other drug?

NNC0113-2023 is the primary name for this investigational drug. No alternative names have been reported for this compound. It is being studied under this identifier in clinical trials for Type 2 diabetes.