Clinical trial

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

Recruiting now · Phase 1 · 1 countries · Registry ID NCT07693868

Recruiting nowPhase 1Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years
SexAll
Healthy volunteersAccepted
ConditionObesity, Elevated High-sensitivity C-reactive Protein (hsCRP)

Full registry 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.

Treatments and study arms

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.

Primary outcomes

Part A: Area under the NNC6022-0001 plasma concentration-time curve from time 0 to last measurable plasma concentration (AUC0-tz) after a single doseFrom pre-dose (Day 1) until visit 3 (Day 9)

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

Part A: Maximum observed plasma concentration (Cmax) of NNC6022-0001 after a single doseFrom pre-dose (Day 1) until visit 3 (Day 9)

Measured as micromolar (µM).

Part B: Number of treatment emergent adverse events (TEAE)From time of dosing (Day 1) to end of study visit (Day 14)

Measured as number of events.

Part C: Number of treatment emergent adverse eventsFrom time of dosing (Day 1) to end of study visit (Day 41)

Measured as number of events.

Part D: Area under the NNC6022-0001 plasma concentration-time curve from time 0 to last measurable plasma concentration (AUC0-tz) after a single doseFrom pre-dose (Day 1 or Day 8) to end of visit (Day 5 or Day 12)

Measured as µM\*h.

Part E: Number of treatment emergent adverse eventsFrom time of dosing (Day 1) to end of study visit (Day 13)

Measured as number of events.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

ICON - location Groningen🇳🇱 Groningen, Netherlands