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NNC9204-1706

Phase 1

Metabolism and Nutrition Disorder | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Oct 18, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

NNC9204-1706 · 1 trial · 2 indications

Phase 1 1
NCT03661879Research Study of a New Medicine (NNC9204-1706) in People With Overweight or ObesityMetabolism and Nutrition Disorder
COMPLETED60 Analytics
PHASE1COMPLETED
Research Study of a New Medicine (NNC9204-1706) in People With Overweight or Obesity
Metabolism and Nutrition DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of treatment emergent adverse events (TEAEs)
Days 1-84

Count of adverse events.

Secondary Endpoints

Change in time-profile (msec) in individual corrected QT interval (ΔQTcI)
Day 1, Day 84
AUC0-24h,SS (h*nmol/L); the area under the NNC9204-1706 plasma concentration-time curve from time 0 to 24 hours at steady state
Days 1-84
Cmax,SS (nmol/L); the maximum plasma concentration of NNC9204-1706 at steady state
Days 1-84
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
NNC9204-1706EXPERIMENTALParticipants will receive NNC9204-1706 for 10 weeks. There will be a 2-week follow-up period after the treatment period.
Placebo (NNC9204-1706)PLACEBO_COMPARATORParticipants will receive placebo (NNC9204-1706) for 10 weeks. There will be a 2-week follow-up period after the treatment period.

Interventions

NameTypeDescription
NNC9204-1706DRUGParticipants will receive NNC9204-1706 subcutaneous (s.c., under the skin) injection(s) once daily (OD) for 10 weeks. They will either receive the same dose throughout the trial, or the dose will be escalated over a period of 1-3 weeks and continued for at least 7 weeks at the same dose.
Placebo (NNC9204-1706)DRUGParticipants will receive matching placebo (NNC9204-1706) s.c., injection(s) OD for 10 weeks.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male or female, aged 18-55 years (both inclusive) at the time of signing informed consent. * Body mass index (BMI) between 25.0 and 39.9 kg/m\^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator. Exclusion Criteria...

Countries:United States
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Frequently asked questions about NNC9204-1706

What is NNC9204-1706 used for?

NNC9204-1706 is an investigational small molecule being developed by Novo Nordisk for the treatment of metabolism and nutrition disorders, specifically overweight and obesity. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

What does NNC9204-1706 target?

The molecular target of NNC9204-1706 has not been disclosed in available information. The drug is being studied for its effects on metabolism and nutrition disorders, including obesity, but its specific mechanism of action is not publicly detailed.

Who makes NNC9204-1706?

NNC9204-1706 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 research to evaluate the drug's safety and efficacy in people with overweight or obesity.

What phase is NNC9204-1706 in?

NNC9204-1706 is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational, meaning it has not been approved for commercial use. Further clinical studies would be needed to assess its potential for regulatory approval.

What clinical trials is NNC9204-1706 in?

NNC9204-1706 has been studied in one completed Phase 1 clinical trial with the identifier NCT03661879. This trial, titled 'Research Study of a New Medicine (NNC9204-1706) in People With Overweight or Obesity,' enrolled 60 participants in the United States and was randomized, double-blind, and placebo-controlled.

Is NNC9204-1706 the same as any other drug?

No alternative names for NNC9204-1706 have been disclosed in available information. The drug is identified solely by its code name NNC9204-1706 in clinical trial registries and public records.