Health Trials

A Study to See How Safe a New Medicine (NNC6022-0004) is in Healthy People and People Living With Obesity

ConditionsObesityElevated High-sensitivity C-reactive Protein (hsCRP)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNovo Nordisk A/S

About this trial

This study is being done to look at the efficacy single and multiple ascending dose study investigating safety, tolerability, pharmacokinetics, food effect and target engagement in healthy adults including a single cohort in adults living with obesity. Participants will either get NNC6022-0004, (the treatment being tested) or Placebo (a treatment that has no active medicine in it) and which treatment participants get is decided by chance.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Male, or female of non-childbearing potential.

For Parts A, B, C and D: Age 18-55 years (both inclusive) at the time of signing the informed consent.

Body weight: ≥50.0 kilogram (kg) 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

Known or suspected hypersensitivity to study intervention(s) or similar products.

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

Any of the below laboratory safety parameters at screening outside normal range, see designated reference range documents for specific values.

Alanine Aminotransferase (ALT) > Upper limit of normal (ULN).

Trial design

Design model

Parallel

Treatments tested in this trial

  • NNC6022-0004

    Drug

    Participants will receive single dose of NNC6022-0004 administered orally in capsule form.

  • Placebo

    Drug

    Participants will receive placebo matched to NNC6022-0004 administered orally in capsule form.

Treatment groups

128 Participants
are divided into 2 treatment groups
Group A: NNC6022-0004Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Part A: Area under the NNC6022-0001 plasma concentration-time curve from time 0 to last measurable plasma concentration (AUC0-tz) after a single dose

Measured as micromolar per hour (µM\*h).

Time frame
From pre-dose (Day 1) until visit 3 (Day 9)
2

Part A: Maximum observed plasma concentration (Cmax) of NNC6022-0001 after a single dose

Measured as micromolar (µM).

Time frame
From pre-dose (Day 1) until visit 3 (Day 9)
3

Part B: Number of treatment emergent adverse events (TEAE)

Measured as number of events.

Time frame
From time of dosing (Day 1) to end of study visit (Day 14)
4

Part C: Number of treatment emergent adverse events

Measured as number of events.

Time frame
From time of dosing (Day 1) to end of study visit (Day 41)

Secondary outcomes

1

Part A: The area under the NNC6022-0001 plasma concentration-time curve from time 0 to infinity (AUC0-∞) after a single dose

Measured as µM\*h.

Time frame
From pre-dose (Day 1) until visit 3 (Day 9)
2

Part A: Number of treatment emergent adverse events

Measured as number of events.

Time frame
From time of dosing (Day 1) to end of study visit (Day 9)
3

Part B: The area under the NNC6022-0001 plasma concentration-time curve from time 0 to last measurable plasma concentration (AUC0-tz) after a single dose

Measured as µM\*h.

Time frame
From pre-dose (Day 1) until visit 3 (Day 9)
4

Part B: The area under the NNC6022-0001 plasma concentration-time curve from time 0 to infinity (AUC0-∞) after a single dose

Measured as µM\*h.

Time frame
From pre-dose (Day 1) until visit 3 (Day 9)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Novo Nordisk A/S

Lead sponsor

Source ClinicalTrials.gov
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