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NNC9204-1513

Phase 1

Diabetes | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Sep 5, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

NNC9204-1513 · 1 trial · 3 indications

Phase 1 1
NCT03444467First Research Study to Compare a Possible New Medicine NNC9204-1513 to the Medicine Glucagon, in Healthy People.Diabetes
COMPLETED36 Analytics
PHASE1COMPLETED
First Research Study to Compare a Possible New Medicine NNC9204-1513 to the Medicine Glucagon, in Healthy People.
DiabetesUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of treatment emergent adverse events (TEAEs)
from time of dosing (day 1) to completion of the safety follow-up visit (day 8)

Count of events

Secondary Endpoints

Change from baseline in haematology
baseline (day 1), follow-up visit (day 8)
Change from baseline in biochemistry
baseline (day 1), follow-up visit (day 8)
Change from baseline in fibrinogen
baseline (day 1), follow-up visit (day 8)
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
NNC9204-1513EXPERIMENTALParticipants will receive increasing doses of NNC9204-1513.
GlucagonACTIVE_COMPARATORParticipants will receive a single fixed dose of glucagon.

Interventions

NameTypeDescription
NNC9204-1513DRUGParticipants will receive NNC9204-1513 subcutaneous (s.c., in to a skin fold on the stomach) injection as single increasing doses of 0.01 mg, 0.04 mg, 0.10 mg, 0.25 mg, 0.50 mg, 1.0 mg or 2.0 mg. Each participant will only be given one dose. Dose escalation will proceed to the next planned dose level if there are no safety concerns raised by the investigator or by the trial safety group.
GlucagonDRUGParticipants will receive single dose of 1 mg glucagon s.c. injection.
PlaceboDRUGParticipants will receive single dose of placebo (for double dummy injections).
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male, aged 18 -55 years (both inclusive), at the time of signing informed consent * Body mass index (BMI) between 18.5 and 28.0 kg/sqm (both inclusive) * Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, ECG ...

Countries:Germany
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Competitive Landscape -Diabetes Complications 6 trials (matched to "Diabetes")

Frequently asked questions about NNC9204-1513

What is NNC9204-1513 used for?

NNC9204-1513 is an investigational small molecule being developed by Novo Nordisk for the treatment of diabetes, including type 1 and type 2 diabetes mellitus. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

What does NNC9204-1513 target?

The molecular target of NNC9204-1513 has not been disclosed in available information. It is a small molecule being studied for its potential effects in diabetes, but its specific mechanism of action is not publicly detailed.

Who makes NNC9204-1513?

NNC9204-1513 is being developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker symbol NVO. The company is conducting clinical trials to evaluate the drug's safety and efficacy in diabetes.

What phase is NNC9204-1513 in?

NNC9204-1513 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory agencies and is still undergoing clinical trials to assess its safety and potential effectiveness in treating diabetes.

What clinical trials is NNC9204-1513 in?

NNC9204-1513 has one completed Phase 1 clinical trial, identified as NCT03444467. This study compared the drug to glucagon in healthy male participants in Germany, with a total enrollment of 36 individuals. The trial was randomized, double-blind, and active-controlled.

Is NNC9204-1513 the same as glucagon?

No, NNC9204-1513 is not the same as glucagon. In a clinical trial, NNC9204-1513 was compared to glucagon as an active control, indicating they are distinct substances. The study aimed to evaluate how the new medicine compares to glucagon in healthy people.