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NNC9204-1177 A/mL

Phase 1

Metabolism and Nutrition Disorder | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Dec 23, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment99

FDA Designations

No designations recorded

Clinical trial landscape

NNC9204-1177 A/mL · 1 trial · 2 indications

Phase 1 1
NCT03308721Research Study Investigating Study Medicine (NNC9204-1177) for Weight Management in People With Overweight or ObesityMetabolism and Nutrition Disorder
COMPLETED99 Analytics
PHASE1COMPLETED
Research Study Investigating Study Medicine (NNC9204-1177) for Weight Management in People With Overweight or Obesity
Metabolism and Nutrition DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of treatment emergent adverse events (TEAEs)
Day 1-110

Count of events

Secondary Endpoints

The area under the NNC9204-1177 serum concentration-time curve at steady state
0-168 hours
The maximum serum concentration of NNC9204-1177 at steady state
Day 78-110
The time to maximum serum concentration of NNC9204-1177
Day 78-110
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
NNC9204-1177EXPERIMENTALDose trial with a sequential trial design
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
NNC9204-1177 A 1.0 mg/mLDRUGParticipants will get 1 or more injections into the skin of the stomach area once each week for 12 weeks. Dose gradually increased to 6000 μg.
PLACEBODRUGParticipants will get 1 or more injections into the skin of the stomach area once each week for 12 weeks.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersNo
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 27.0 and 39.9 kg/m2 (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 NNC9204-1177 A/mL

What is NNC9204-1177 A/mL used for?

NNC9204-1177 A/mL is an investigational small molecule being developed for metabolism and nutrition disorders, specifically for weight management in people with overweight or obesity. It is being studied as a potential treatment to address these metabolic conditions.

Who makes NNC9204-1177 A/mL?

NNC9204-1177 A/mL is being developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker NVO. The company is conducting clinical research to evaluate the drug's safety and efficacy.

What phase is NNC9204-1177 A/mL in?

NNC9204-1177 A/mL is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and effectiveness.

What clinical trials is NNC9204-1177 A/mL in?

NNC9204-1177 A/mL has one completed clinical trial, identified as NCT03308721. This Phase 1 study was a randomized, double-blind, placebo-controlled trial conducted in the United States, enrolling 99 participants with overweight or obesity.

Is NNC9204-1177 A/mL the same as NNC9204-1177?

NNC9204-1177 A/mL is a formulation of the drug NNC9204-1177. The clinical trial NCT03308721 refers to the study medicine as NNC9204-1177, and the A/mL designation indicates a specific concentration or formulation used in the research.