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NNC0148-0287sema

Phase 1

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Nov 12, 2024

Success Probability

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

NNC0148-0287sema · 1 trial · 1 indication

Phase 1 1
NCT03789578A Research Study to Look at How Insulin 287 and Semaglutide Work in the Body of People With Type 2 Diabetes When Taken Alone or TogetherDiabetes Mellitus, Type 2
COMPLETED30 Analytics
PHASE1COMPLETED
A Research Study to Look at How Insulin 287 and Semaglutide Work in the Body of People With Type 2 Diabetes When Taken Alone or Together
Diabetes Mellitus, Type 2Unlock trial analytics

Study Endpoints

Primary Endpoints

AUCI287, 0-tz, area under the serum insulin 287 concentration-time curve from 0 hours to last quantifiable observation after a single dose
0-840 hours

Measured in pmol\*h/L for insulin 287 following administration of a fixed ratio of NNC0148-0287sema and insulin 287.

AUCSema,0-tz, area under the plasma semaglutide concentration-time curve from 0 hours to last quantifiable observation after a single dose
0-840 hours

Measured in pmol\*h/L for semaglutide following administration of a fixed ratio of NNC0148-0287sema and semaglutide.

Secondary Endpoints

AUCI287,0-∞ area under the serum insulin 287 concentration-time curve from 0 hours to infinity after a single dose
0-840 hours
Cmax, I287, maximum observed serum insulin 287 concentration after a single dose
0-840 hours
tmax, I287, time to maximum observed serum insulin 287 concentration after a single dose
0-840 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Semaglutide plus insulin 287EXPERIMENTALParticipants will get a single dose of fixed-ratio combination of insulin 287 and semaglutide (NNC0148-0287sema (treatment C)).
Semaglutide aloneEXPERIMENTALParticipants will get a single dose of semaglutide (treatment B) alone.
Insulin 287 aloneEXPERIMENTALParticipants will get a single dose of insulin 287 (NNC0148-0287 (treatment A)) alone.

Interventions

NameTypeDescription
NNC0148-0287semaDRUGStudy staff will inject NNC0148-0287sema, 175unit (U)/0.5 mg in the morning after fasting under the skin of participants' thigh using a needle and a pen.
SemaglutideDRUGStudy staff will inject semaglutide, 0.5 mg alone in the morning after fasting under the skin of participants' thigh using a needle and a pen.
NNC0148-0287DRUGStudy staff will inject insulin 287 (NNC0148-0287), 175U alone in the morning after fasting under the skin of participants' thigh using a needle and a pen.
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Eligibility Criteria

Age Range18 Years to 64 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male or female, aged 18-64 years (both inclusive) at the time of signing informed consent * Diagnosed with type 2 diabetes mellitus more than or equal to 180 days prior to the day of screening * Body weight between 80.0 to 120.0 kg (both inclusive) * Glycosylated haemoglobin (...

Countries:Germany
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Frequently asked questions about NNC0148-0287sema

What is NNC0148-0287sema used for?

NNC0148-0287sema is an investigational small molecule being studied for the treatment of Type 2 Diabetes Mellitus. It is a metabolic therapeutic developed by Novo Nordisk A/S. As of now, it is in Phase 1 clinical development and has not been approved for any use.

Who is developing NNC0148-0287sema?

NNC0148-0287sema is being developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker NVO. The drug is currently in Phase 1 clinical trials for Type 2 Diabetes Mellitus.

What phase is NNC0148-0287sema in?

NNC0148-0287sema is in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The drug is being studied for the treatment of Type 2 Diabetes Mellitus.

What clinical trials is NNC0148-0287sema in?

NNC0148-0287sema has one completed clinical trial, identified as NCT03789578. This Phase 1 study, conducted in Germany, enrolled 30 participants and examined how the drug works in the body of people with Type 2 Diabetes when taken alone or together with insulin 287.

Is NNC0148-0287sema the same as semaglutide?

NNC0148-0287sema is a distinct investigational drug developed by Novo Nordisk. While its name includes 'sema', it is not stated to be the same as semaglutide. The drug is being studied for Type 2 Diabetes Mellitus and is currently in Phase 1 clinical trials.