New medicine NNC6022-0004 safety in healthy people and adults with obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1, interventional study investigates single and multiple ascending doses of NNC6022-0004 to evaluate safety, tolerability, pharmacokinetics, food effects, and target engagement. The trial includes a single cohort of adults living with obesity and uses random assignment to NNC6022-0004 or placebo across five parts. Participants are healthy adults aged 18-55 (Parts A–D) and may enroll adults 18-65 (Part E) with obesity or elevated hsCRP criteria, depending on the part. The study is sponsored by Novo Nordisk A/S with ICON as the site location in Groningen, Netherlands.

Why it matters

Who can join: the full rules

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.

Where it's running

• ICON - location Groningen
  Groningen, Netherlands Recruiting

Study contacts

• Study coordinator: Novo Nordisk
• Email: clinicaltrials@novonordisk.com
• Phone: (+1) 866-867-7178

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.