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Not yet recruiting NCT07693868

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

Phase I Interventional Obesity Elevated High-sensitivity C-reactive Protein (hsCRP)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NNC6022-0004, Placebo.
Who it may be relevant to
Registry conditions: Obesity, Elevated High-sensitivity C-reactive Protein (hsCRP). Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An NNC6022-0004 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

Overview

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.

Detailed description

The study consists of 5 Parts (Parts A to E and the participants will be assessed based on the study intervention received (NNC6022-0004 or Placebo).

Interventions

  • Drug NNC6022-0004
    Participants will receive single dose of NNC6022-0004 administered orally in capsule form.
  • Drug Placebo
    Participants will receive placebo matched to NNC6022-0004 administered orally in capsule form.

Primary outcome measures

  • 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 [Time frame: From pre-dose (Day 1) until visit 3 (Day 9)]
  • Part A: Maximum observed plasma concentration (Cmax) of NNC6022-0001 after a single dose [Time frame: From pre-dose (Day 1) until visit 3 (Day 9)]
  • Part B: Number of treatment emergent adverse events (TEAE) [Time frame: From time of dosing (Day 1) to end of study visit (Day 14)]
  • Part C: Number of treatment emergent adverse events [Time frame: From time of dosing (Day 1) to end of study visit (Day 41)]
  • Part D: Area under the NNC6022-0001 plasma concentration-time curve from time 0 to last measurable plasma concentration (AUC0-tz) after a single dose [Time frame: From pre-dose (Day 1 or Day 8) to end of visit (Day 5 or Day 12)]
  • Part E: Number of treatment emergent adverse events [Time frame: From time of dosing (Day 1) to end of study visit (Day 13)]
Secondary outcome measures (12)
  • Part A: The area under the NNC6022-0001 plasma concentration-time curve from time 0 to infinity (AUC0-∞) after a single dose [Time frame: From pre-dose (Day 1) until visit 3 (Day 9)]
  • Part A: Number of treatment emergent adverse events [Time frame: From time of dosing (Day 1) to end of study visit (Day 9)]
  • 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 [Time frame: From pre-dose (Day 1) until visit 3 (Day 9)]
  • Part B: The area under the NNC6022-0001 plasma concentration-time curve from time 0 to infinity (AUC0-∞) after a single dose [Time frame: From pre-dose (Day 1) until visit 3 (Day 9)]
  • Part B: The maximum observed plasma concentration (Cmax) of NNC6022-0001 after a single dose [Time frame: From pre-dose (Day 1) until visit 3 (Day 9)]
  • Part B: Proportion of administered dose recovered as unchanged drug in urine (Fe0-72h), calculated as Ae0-72hour/ dose [Time frame: From dose (Day 1) until 72h post-dose]
  • Part C: The area under the NNC6022-0001 plasma concentration-time curve from time 0 to tau (AUCtau) after the last dose [Time frame: From pre-dose (Day 28) to tau after last dose (Day 29)]
  • Part C: The maximum observed plasma concentration (Cmax) of NNC6022-0001 after last dose [Time frame: From pre-dose (Day 28) until visit 3 (Day 35)]
  • Part C: interleukin β (IL-1β) (ex vivo): ratio of plasma level at time tau after last dose to baseline [Time frame: From pre-dose (Day 1) to tau after last dose (Day 29)]
  • Part D: The area under the NNC6022-0001 plasma concentration-time curve from time 0 to infinity (AUC0-∞) after a single dose [Time frame: From pre-dose (Day 1 or Day 8) to end of visit (Day 5 or Day 12)]
  • Part D: The maximum observed plasma concentration (Cmax) of NNC6022-0001 after a single dose [Time frame: From pre-dose (Day 1 or Day 8) to end of visit (Day 5 or Day 12)]
  • Part D: Number of treatment emergent adverse events [Time frame: From time of dosing (Day 1) to end of visit (Day 16)]

Eligibility criteria

Inclusion criteria

  • 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.

For optional Part E only: Age 18-65 years (both inclusive) at the time of signing the informed consent.

-For Parts A, B, C and D: Body mass index (BMI) between 18.5 to 29.9 kilogram per meter square (kg/m\^2) (both inclusive) at screening.

For optional Part E only: BMI between greater than or equal to (≥) 30.0 to less than or equal to (≤) 45.0 kg/m\^2 at screening, or if BMI is between 27.0 and <30.0 kg/m\^2, waist to height ratio should be greater than (>)0.5.

  • 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.
  • For optional Part E only: hsCRP ≥2.00 and ≤8.00 milligrams per liter (mg/L) during screening period in 2 separate samples taken ≥4 days apart.

Exclusion criteria

  • 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).
  • Alkaline Phosphatase (ALP) > ULN.
  • Aspartate aminotransferase (AST) > ULN.
  • Total Bilirubin (TBL) > ULN.
  • Creatinine > ULN.
  • International normalized ratio (INR) > ULN.
  • Fibrinogen outside normal range of 1.6 - 4.2 grams per liter (g/L).
  • hsCRP > 5.00 mg/L (males) and > 8.00 mg/L (females)\*.
  • applicable for Parts A, B, C and D and for optional Part E: hsCRP >8.00 mg/L.
  • Use of prescription medicinal products or vaccines within 14 days before screening and/or non prescription medicinal products within 7 days before dosing. Exceptions are: Topical medications not reaching systemic circulation; less than once per week of over-the-counter paracetamol, ibuprofen and/or acetylsalicylic acid at their labelled doses for mild pain; vitamins at their labelled doses.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Netherlands · 1 center
  • ICON - location Groningen — Groningen

Identifiers

NCT: NCT07693868 · NN6022-8271 · U1111-1333-6460 · 2026-525179-26

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗