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NNC9204-1177

Phase 1

Healthy Volunteers | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Jan 22, 2020

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment45

FDA Designations

No designations recorded

Clinical trial landscape

NNC9204-1177 · 2 trials · 4 indications

Phase 1 2
NCT04059367Research Study to Investigate How a Study Medicine (NNC9204- 1177) Affects Blood Levels of Other Medicines in Healthy PeopleHealthy Volunteers
COMPLETED45 Analytics
NCT02941042A First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-1177 in Subjects Being Overweight or With Obesity.Metabolism and Nutrition Disorder
COMPLETED49 Analytics
PHASE1COMPLETED
Research Study to Investigate How a Study Medicine (NNC9204- 1177) Affects Blood Levels of Other Medicines in Healthy People
Healthy VolunteersUnlock trial analytics
PHASE1COMPLETED
A First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-1177 in Subjects Being Overweight or With Obesity.
Metabolism and Nutrition DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

Area under the plasma concentration-time curve extrapolated to infinity of the caffeine
From 0 to 24 hours after a single dose of caffeine without NNC9204-1177 exposure (administered on Visit 2, Day 1) and at NNC9204-1177 steady state (administered on Visit 12, Day 78)

ng\*h/mL

Area under the plasma concentration-time curve extrapolated to infinity of the omeprazole
From 0 to 8 hours after a single dose of omeprazole without NNC9204-1177 exposure (administered on Visit 2, Day 1) and at NNC9204-1177 steady state (administered on Visit 12, Day 78)

ng\*h/mL

Area under the plasma concentration-time curve extrapolated to infinity of the midazolam
From 0 to 12 hours after a single dose of midazolam without NNC9204-1177 exposure (administered on Visit 2, Day 1) and at NNC9204-1177 steady state (administered on Visit 12, Day 78)

ng\*h/mL

Area under the plasma concentration-time curve extrapolated to infinity of the s-warfarin
From 0 to 168 hours after a single dose of warfarin without NNC9204-1177 exposure (administered on Visit 2, Day 1) and at NNC9204-1177 steady state (administered on Visit 12, Day 78)

ng\*h/mL

Area under the plasma concentration-time curve extrapolated to infinity of the dextromethorphan
From 0 to 72 hours after a single dose of dextromethorphan without NNC9204-1177 exposure (administered on Visit 2, Day 1) and at NNC9204-1177 steady state (administered on Visit 12, Day 78)

ng\*h/mL

Number of treatment emergent adverse events (TEAEs)
From time of dosing (day 1) until completion of the follow-up visit (day 39)

Secondary Endpoints

Maximum observed plasma caffeine concentration after a single dose
From 0 to 24 hours after a single dose of caffeine without NNC9204-1177 exposure (administered on Visit 2, Day 1) and at NNC9204-1177 steady state (administered on Visit 12, Day 78)
Maximum observed plasma omeprazole concentration after a single dose
From 0 to 8 hours after a single dose of omeprazole without NNC9204-1177 exposure (administered on Visit 2, Day 1) and at NNC9204-1177 steady state (administered on Visit 12, Day 78)
Maximum observed plasma s-warfarin concentration after a single dose
From 0 to 168 hours after a single dose of warfarin without NNC9204-1177 exposure (administered on Visit 2, Day 1) and at NNC9204-1177 steady state (administered on Visit 12, Day 78)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
NNC9204-1177 and cocktail of approved drugsEXPERIMENTAL -
NNC9204-1177EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
NNC9204-1177DRUGIncreasing doses of NNC9204-1177 administered s.c. (subcutaneously, under the skin) in the stomach area once-weekly for 11 weeks
Cocktail of 5 already approved drugsDRUG5 medicines as tablets, capsules or syrup to be taken with water on Day 1 and Day 78 of the study
PlaceboDRUGA single dose administered subcutaneously ( s.c. under the skin)
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male or female, aged 18-60 years (both inclusive) at the time of signing informed consent. * Body mass index (BMI) between 23.0 and 29.9 kg/m\^2 (both inclusive) at screening. * Considered to be generally healthy based on the medical history, physical examination, and the resu...

Countries:United States
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Frequently asked questions about NNC9204-1177

What is NNC9204-1177 used for?

NNC9204-1177 is an investigational small molecule being studied for metabolism and nutrition disorders, including obesity and overweight. It is in Phase 1 clinical development and has been evaluated in healthy volunteers and subjects who are overweight or have obesity.

Who makes NNC9204-1177?

NNC9204-1177 is being developed by Novo Nordisk A/S, a biopharmaceutical company listed on the stock exchange under the ticker NVO. The drug is in early-stage clinical development for metabolic conditions.

What phase is NNC9204-1177 in?

NNC9204-1177 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to assess its safety, tolerability, and pharmacokinetics.

What clinical trials is NNC9204-1177 in?

NNC9204-1177 has been studied in two completed Phase 1 trials. NCT02941042 investigated single doses in overweight or obese subjects, and NCT04059367 examined how the drug affects blood levels of other medicines in healthy people. Both trials were conducted in the United States.

Is NNC9204-1177 the same as any other drug?

NNC9204-1177 is the investigational name used in clinical trials for this drug candidate. No alternative names have been reported for this compound in the available clinical trial information.