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NNC9204-0530

Phase 1

Metabolism and Nutrition Disorder | 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-BlindPLACEBO_CONTROLLED
Total Trials3
Total Enrollment398

FDA Designations

No designations recorded

Clinical trial landscape

NNC9204-0530 · 3 trials · 2 indications

Phase 1 3
NCT02870231Investigating Safety, Tolerability, PK and PD for Multiple Doses of NNC9204-0530 in Combination With Liraglutide in Male and Female Subjects Being Overweight or With ObesityMetabolism and Nutrition Disorder
COMPLETED187 Analytics
NCT02835235A Trial Investigating Safety, Tolerability, PK and PD for Multiple Doses of NNC9204-0530 in Male and Female Subjects Being Overweight or With ObesityMetabolism and Nutrition Disorder
COMPLETED48 Analytics
NCT02235961Investigate Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-0530 Alone and in Combination With Liraglutide in Overweight to Obese But Otherwise Healthy Male SubjectsMetabolism and Nutrition Disorder
COMPLETED163 Analytics
PHASE1COMPLETED
Investigating Safety, Tolerability, PK and PD for Multiple Doses of NNC9204-0530 in Combination With Liraglutide in Male and Female Subjects Being Overweight or With Obesity
Metabolism and Nutrition DisorderUnlock trial analytics
PHASE1COMPLETED
A Trial Investigating Safety, Tolerability, PK and PD for Multiple Doses of NNC9204-0530 in Male and Female Subjects Being Overweight or With Obesity
Metabolism and Nutrition DisorderUnlock trial analytics
PHASE1COMPLETED
Investigate Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-0530 Alone and in Combination With Liraglutide in Overweight to Obese But Otherwise Healthy Male Subjects
Metabolism and Nutrition DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of treatment emergent adverse events
Day 1-112
Number of treatment emergent adverse events recorded
From time of dosing of NNC9204-0530 (Day 1) until completion of the follow-up visit (Day 21-27)

Secondary Endpoints

Area under the NNC9204-0530 serum concentration-time curve
Day 84-112
Time to maximum serum concentration of NNC9204-0530
Day 84-112
Change in HbA1C
Day -1, Day 85
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
NNC9204-0530 / Placebo and Liraglutide 1.8EXPERIMENTAL -
NNC9204-0530 /Placebo and Liraglutide 3.0ACTIVE_COMPARATOR -
NNC9204-0530EXPERIMENTALDose-escalation within the cohort before reaching final dose
PlaceboPLACEBO_COMPARATOR -
Part 1EXPERIMENTAL -
Part 2EXPERIMENTAL -

Interventions

NameTypeDescription
NNC9204-0530DRUGOnce-daily subcutaneous (s.c., under the skin) administration.
liraglutideDRUGOnce-daily subcutaneous (s.c., under the skin) administration.
placeboDRUGOnce-daily subcutaneous (s.c., under the skin) administration
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Body mass index between 25.0 and 39.9 kg/m\^2 (both inclusive) at screening. * Male or female, age between 18 and 55 years (both inclusive) at the time of signing informed consent Exclusion Criteria: * Any clinically significant weight change (equal or above 5% self-reported...

Countries:United States
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Frequently asked questions about NNC9204-0530

What is NNC9204-0530 used for?

NNC9204-0530 is an investigational small molecule being developed for metabolism and nutrition disorders, specifically obesity. It is being studied in overweight or obese individuals to evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamics. The drug is in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes NNC9204-0530?

NNC9204-0530 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 trials to investigate the drug's effects in overweight and obese subjects, including its use alone and in combination with liraglutide.

What phase is NNC9204-0530 in?

NNC9204-0530 is in Phase 1 clinical development. All three clinical trials for this drug have been completed, with a total enrollment of 398 participants. The trials were randomized, double-blind, and placebo-controlled, focusing on safety, tolerability, pharmacokinetics, and pharmacodynamics in overweight or obese individuals.

What clinical trials is NNC9204-0530 in?

NNC9204-0530 has been studied in three completed Phase 1 trials: NCT02235961, which investigated single doses alone and with liraglutide in overweight to obese healthy male subjects; NCT02835235, which studied multiple doses in overweight or obese male and female subjects; and NCT02870231, which investigated multiple doses in combination with liraglutide in overweight or obese subjects.

Is NNC9204-0530 the same as liraglutide?

No, NNC9204-0530 is not the same as liraglutide. NNC9204-0530 is an investigational small molecule being studied for obesity, while liraglutide is a separate medication. In clinical trials, NNC9204-0530 has been tested both alone and in combination with liraglutide to evaluate their combined effects in overweight or obese individuals.