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Co-formulation NNC0480 0389+Semaglutide A 10/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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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Clinical trial landscape

Co-formulation NNC0480 0389+Semaglutide A 10/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 2
NCT0504687316
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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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