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NNC0497-0040

Phase 1

Type 1 Diabetes (T1D) | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Jun 4, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment146

FDA Designations

No designations recorded

Clinical trial landscape

NNC0497-0040 · 1 trial · 4 indications

Phase 1 1
NCT07578584A Research Study Investigating the Effect of NNC0497-0040 in Healthy Participants, Participants With Overweight or Obesity, and Participants With Type 1 Diabetes With Overweight or ObesityType 1 Diabetes (T1D)
RECRUITING146 Analytics
PHASE1RECRUITING
A Research Study Investigating the Effect of NNC0497-0040 in Healthy Participants, Participants With Overweight or Obesity, and Participants With Type 1 Diabetes With Overweight or Obesity
Type 1 Diabetes (T1D)Unlock trial analytics

Study Endpoints

Primary Endpoints

Number of adverse events
Day 1 up to Week 6

Measured in events

Secondary Endpoints

Area under the serum NNC0497-0040 concentration time curve
Day 1
Cmax: Maximum observed serum NNC0497-0040 concentration
Day 1
Area under the serum NNC0497-0040 concentration time curve at steady state
MAD1-2: Week 12; MAD3: Week 20
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SADEXPERIMENTALParticipants will receive NNC0497-0040 or placebo matched to NNC0497-0040 subcutaneously.
MAD1EXPERIMENTALParticipants will receive NNC0497-0040 or placebo matched to NNC0497-0040 subcutaneously.
MAD2EXPERIMENTALParticipants will receive NNC0497-0040 or placebo matched to NNC0497-0040 subcutaneously.
MAD3EXPERIMENTALParticipants will receive NNC0497-0040 or placebo matched to NNC0497-0040 subcutaneously.
MAD4EXPERIMENTALParticipants will receive NNC0497-0040 or placebo matched to NNC0497-0040 subcutaneously.

Interventions

NameTypeDescription
NNC0497-0040DRUGNNC0497-0040 will be administered subcutaneously.
PlaceboDRUGPlacebo will be administered subcutaneously.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites1

For SAD cohorts Inclusion Criteria: * Female of non-childbearing potential or male aged 18-55 years (both inclusive) at screening. * Body mass index between 18.5 kilogram per m\^2 and 29.9 kilogram per m\^2 (both inclusive) at screening. * Considered to be generally healthy based on the medical hi...

Countries:Germany
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Competitive Landscape -Diabetes Complications 6 trials (matched to "Type 1 Diabetes (T1D)")

Frequently asked questions about NNC0497-0040

What is NNC0497-0040 used for?

NNC0497-0040 is an investigational small molecule being developed for Type 1 Diabetes (T1D). It is also being studied in participants with overweight or obesity, including those with Type 1 Diabetes who have overweight or obesity. The drug is currently in Phase 1 clinical development.

Who makes NNC0497-0040?

NNC0497-0040 is being developed by Novo Nordisk A/S, a biopharmaceutical company. Novo Nordisk's stock is listed under the ticker symbol NVO. The company is conducting clinical trials to evaluate the drug's effects in participants with Type 1 Diabetes and related conditions.

What phase is NNC0497-0040 in?

NNC0497-0040 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is currently being studied in a Phase 1 trial that is recruiting participants, and it remains in the early stages of clinical testing.

What clinical trials is NNC0497-0040 in?

NNC0497-0040 is being studied in a Phase 1 clinical trial with the identifier NCT07578584. This trial is investigating the drug's effect in healthy participants, participants with overweight or obesity, and participants with Type 1 Diabetes who have overweight or obesity. The trial is recruiting participants in Germany.

Is NNC0497-0040 a randomized controlled trial?

Yes, the Phase 1 clinical trial of NNC0497-0040 is randomized, double-blind, and controlled. This means participants are randomly assigned to receive the drug or a control, and neither the participants nor the researchers know which treatment is being administered. The trial is designed to evaluate the drug's effects in a controlled setting.