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NNC0480-0389 A/mL

Phase 1

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Jul 3, 2023

Success Probability

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Clinical trial landscape

NNC0480-0389 A/mL · 1 trial · 1 indication

Phase 1 1
NCT05046873A Research Study Looking Into Blood Levels of Semaglutide and NNC0480-0389 When Given in the Same Injection or in Two Separate Injections in Healthy PeopleDiabetes Mellitus, Type 2
COMPLETED16 Analytics
PHASE1COMPLETED
A Research Study Looking Into Blood Levels of Semaglutide and NNC0480-0389 When Given in the Same Injection or in Two Separate Injections in Healthy People
Diabetes Mellitus, Type 2Unlock trial analytics

Study Endpoints

Primary Endpoints

AUC0-∞,sema,SD: Area under the semaglutide plasma concentration-time curve after a single dose
From baseline (visit 2/12, day 1, pre-dose) until completion of the assessment period (visit 11/21, day 36)

h\*nmol/L

AUC0-∞,NNC0480-0389,SD: Area under the NNC0480-0389 plasma concentration-time curve after a single dose
From baseline (visit 2/12, day 1, pre-dose) until completion of the assessment period (visit 11/21, day 36)

h\*nmol/L

Secondary Endpoints

Cmax,sema,SD: Maximum plasma concentration of semaglutide after a single dose
From baseline (visit 2/12, day 1, pre-dose) until completion of the assessment period (visit 11/21, day 36)
Cmax,NNC0480-0389,SD: Maximum plasma concentration of NNC0480-0389 after a single dose
From baseline (visit 2/12, day 1, pre-dose) until completion of the assessment period (visit 11/21, day 36)
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
NNC0480-0389 + semaglutide(co-formulation)and placeboEXPERIMENTALSequence A: The participants will be administered a single subcutanous (s.c.) dose of 0.5 mg semaglutide and 5 mg NNC0480 0389 on two separate dosing visits separated by at least 8 weeks. The two drugs will be administered as a co-formulation by a single injection and a placebo injection
NNC0480-0389 + semaglutide (separate injections)ACTIVE_COMPARATORSequence B: The participants will be administered 0.5 mg semaglutide and 5 mg NNC0480 0389 as an subcutaneus injection (s.c) on two separate dosing visits separated by at least 8 weeks. The two drugs will be administered as two separate injections.

Interventions

NameTypeDescription
Co-formulation NNC0480 0389+Semaglutide A 10/1 mg/mLDRUGParticipants will receive a subcutaneus (s.c) co-formulation injection of 0.5 mg semaglutide and 5 mg NNC0480-0389 together with a subcutaneus injection (s.c) of semaglutide(placebo)on two separate dosing visits separated by at least 8 weeks.
semaglutide 1.34 mg/mL (placebo)DRUGParticipants will receive a subcutaneus (s.c) co-formulation injection of 0.5 mg semaglutide and 5 mg NNC0480-0389 together with a subcutaneus injection (s.c) of semaglutide(placebo)on two separate dosing visits separated by at least 8 weeks.
Semaglutide 1.34 mg/mLDRUGThe participants will be receive a subcutaneus (s.c) injection of 0.5 mg semaglutide and 5 mg NNC0480 0389 on two separate doing visits separated by at least 8 weeks.
NNC0480-0389 A 10 mg/mLDRUGThe participants will be receive a subcutaneus (s.c) injection of 0.5 mg semaglutide and 5 mg NNC0480 0389 on two separate doing visits separated by at least 8 weeks.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male or female of non-childbearing potential (NCBP), aged 18-55 years (both inclusive) at the time of signing informed consent. * Body mass index (BMI) between 20.0 and 29.9 kg/m\^2 (both inclusive). Exclusion Criteria: * Any disorder which in the investigator's opinion migh...

Countries:Germany
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Frequently asked questions about NNC0480-0389 A/mL

What is NNC0480-0389 A/mL used for?

NNC0480-0389 A/mL is an investigational small molecule being developed by Novo Nordisk for the treatment of Type 2 Diabetes Mellitus. It is currently in Phase 1 clinical development, meaning it is still being studied and has not been approved for use.

Who makes NNC0480-0389 A/mL?

NNC0480-0389 A/mL is being developed by Novo Nordisk A/S, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVO. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetics.

What phase is NNC0480-0389 A/mL in?

NNC0480-0389 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 how it behaves in the body.

What clinical trials is NNC0480-0389 A/mL in?

NNC0480-0389 A/mL has one completed Phase 1 clinical trial, identified as NCT05046873. This study, conducted in Germany, enrolled 16 healthy participants to investigate blood levels of semaglutide and NNC0480-0389 when given in the same injection or in two separate injections.

Is NNC0480-0389 A/mL the same as semaglutide?

NNC0480-0389 A/mL is not the same as semaglutide. It is a separate investigational compound being studied by Novo Nordisk. A clinical trial (NCT05046873) compared the blood levels of both drugs when administered together or separately, indicating they are distinct molecules.