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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorNovo Nordisk A/S

About this trial

The purpose of this clinical study is to find out if NNC0497-0040 is safe, tolerable and effective for healthy people living with normal weight or overweight, people living with overweight or obesity and people who have type 1 diabetes and are living with overweight or obesity. There are 2 study treatments in this study, where participants will get either NNC0497-0040, the new treatment being tested or placebo, a treatment that has no active medicine in it. Participants will be in this clinical study for up to 29 weeks.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female of non-childbearing potential or male aged 18-55 years (both inclusive) at screening.

Body mass index between 18.5 kilogram per m² and 29.9 kilogram per m² (both inclusive) at screening.

Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Disqualifiers

Any disorder, unwillingness or inability which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.

Glycated haemoglobin (HbA1c) above or equal to 6.5 percentage (48 millimoles per mole) at screening.

Unwilling or unable to refrain from use of prescription medicinal products or non-prescription drugs, including use of herbal products and non-routine vitamins, within 14 days prior to the first day of dosing. Occasional use of paracetamol and ibuprofen to treat acute pain is permitted until 24 hours prior to dosing.

Female of non-childbearing potential or male aged 18-55 years (both inclusive) at screening.

Trial design

Design model

Sequential

Treatments tested in this trial

  • NNC0497-0040

    Drug

    NNC0497-0040 will be administered subcutaneously.

  • Placebo

    Drug

    Placebo will be administered subcutaneously.

Treatment groups

146 Participants
are divided into 5 treatment groups
Group A: SADExperimental treatment 2 interventions
Group B: MAD1Experimental treatment 2 interventions
Group C: MAD2Experimental treatment 2 interventions
Group D: MAD3Experimental treatment 2 interventions
Group E: MAD4Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Number of adverse events

Measured in events

Time frame
Day 1 up to Week 6
2

Number of adverse events

Measured in events

Time frame
MAD1-2: Day 1 up to Week 17; MAD3: Day 1 up to Week 25
3

Number of adverse events

Measured in events

Time frame
Day 1 up to Week 25

Secondary outcomes

1

Area under the serum NNC0497-0040 concentration time curve

Measured in hours \* nanomoles per litre (h\*nmol/L)

Time frame
Day 1
2

Cmax: Maximum observed serum NNC0497-0040 concentration

Measured in nanomoles per litre (nmol/L)

Time frame
Day 1
3

Area under the serum NNC0497-0040 concentration time curve at steady state

Measured in hours \* nanomoles per litre (h\*nmol/L)

Time frame
MAD1-2: Week 12; MAD3: Week 20
4

Cmax: Maximum observed serum NNC0497-0040 concentration at steady state

Measured in nanomoles per litre (nmol/L)

Time frame
MAD1-2: Week 12; MAD3: Week 20

Other outcomes

Sponsors and contacts

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