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NNC9204-1706 A

Phase 1

Metabolism and Nutrition Disorder | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Oct 5, 2018

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment34

FDA Designations

No designations recorded

Clinical trial landscape

NNC9204-1706 A · 1 trial · 2 indications

Phase 1 1
NCT03095807Investigation of Single Ascending Doses of NNC9204-1706 in Male Subjects Being Overweight or With ObesityMetabolism and Nutrition Disorder
COMPLETED34 Analytics
PHASE1COMPLETED
Investigation of Single Ascending Doses of NNC9204-1706 in Male Subjects Being Overweight or With Obesity
Metabolism and Nutrition DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of treatment-emergent adverse events (TEAEs)
From the time of dosing (Day 1) and until completion of the post-treatment follow-up visit (Days 10-13)

Count and % of events

Secondary Endpoints

Area under the NNC9204-1706 plasma concentration-time curve
Day 1- Day 7
Area under the NNC9204-1706 plasma concentration-time curve (0-24h)
Day 1- Day 7
Area under the NNC9204-1706 plasma concentration-time curve (0- to last quantifiable sample)
Day 1- Day 7
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
NNC9204-1706 AEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
NNC9204-1706 ADRUGAdministered subcutaneously (s.c., under the skin) Up to 7 dose cohorts will be investigated.
PlaceboDRUGAdministered subcutaneously (s.c., under the skin)
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male subjects aged 18-55 years (both inclusive) at the time of signing informed consent * Body mass index (BMI) between 25.0 and 34.9 kg/m\^2 (both inclusive) at screening. Overweight should be due to excess of adipose tissue, as judged by the investigator Exclusion Criteria:...

Countries:United States
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Frequently asked questions about NNC9204-1706 A

What is NNC9204-1706 A used for?

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

Who makes NNC9204-1706 A?

NNC9204-1706 A is being developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker NVO.

What phase is NNC9204-1706 A in?

NNC9204-1706 A is in Phase 1 clinical development. It is an investigational drug and has not been approved for any use. One Phase 1 trial has been completed.

What clinical trials is NNC9204-1706 A in?

NNC9204-1706 A has one completed Phase 1 trial, NCT03095807, which investigated single ascending doses in 34 male subjects who were overweight or had obesity. The trial was randomized, double-blind, and placebo-controlled, and took place in the United States.

Is NNC9204-1706 A the same as any other drug?

No alternative names for NNC9204-1706 A have been disclosed. It is identified by its code name NNC9204-1706 A in clinical trial records.