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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity; Elevated High-sensitivity C-reactive Protein (hsCRP)
• Intervention / Treatment: Drug: NNC6022-0004; Drug: Placebo

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).

• Study Type: Interventional
• Enrollment (Estimated): 128
• Phase: Phase 1

Contacts and Locations

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

Study Locations

• Netherlands
  • Groningen, Netherlands, 9728 NZ
    • ICON - location Groningen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NNC6022-0004; Participants will receive NNC6022-0004 administered orally as a single ascending dose (SAD), multiple ascending dose (MAD), or under fed/fasted conditions.	Drug: NNC6022-0004; Participants will receive single dose of NNC6022-0004 administered orally in capsule form.
Placebo Comparator: Placebo; Participants will receive placebo matched to NNC6022-0004 administered orally as a SAD, MAD, or under fed/fasted conditions.	Drug: Placebo; Participants will receive placebo matched to NNC6022-0004 administered orally in capsule form.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	From pre-dose (Day 1) until visit 3 (Day 9)
Part A: Maximum observed plasma concentration (Cmax) of NNC6022-0001 after a single dose	Measured as micromolar (µM).	From pre-dose (Day 1) until visit 3 (Day 9)
Part B: Number of treatment emergent adverse events (TEAE)	Measured as number of events.	From time of dosing (Day 1) to end of study visit (Day 14)
Part C: Number of treatment emergent adverse events	Measured as number of events.	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	Measured as µM*h.	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	Measured as number of events.	From time of dosing (Day 1) to end of study visit (Day 13)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From pre-dose (Day 1) until visit 3 (Day 9)
Part A: Number of treatment emergent adverse events	Measured as number of events.	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	Measured as µM*h.	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	Measured as µM*h.	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	Measured as µM.	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	Measured as proportion of dose.	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	Measured as µM*h.	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	Measured as µM.	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	Measured as ratio	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	Measured as µM*h.	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	Measured as µM.	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	Measured as number of events.	From time of dosing (Day 1) to end of visit (Day 16)
Part E: Ratio of plasma level at time tau after last dose to baseline (hsCRP)	Measured as ratio.	From pre-dose (Day 1) to tau after last dose (Day 8)
Part E: The area under the NNC6022-0001 plasma concentration-time curve from time 0 to tau (AUCtau) after last dose	Measured as µM*h .	From pre-dose (Day 7) to tau after last dose (Day 8)
Part E: The maximum observed plasma concentration (Cmax) of NNC6022 0001 after last dose	Measured as µM.	From pre-dose (Day 7) until visit 3 (Day 13)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency dept. 2834, Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Estimated): July 6, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: July 3, 2026
• First Submitted That Met QC Criteria: July 3, 2026
• First Posted (Actual): July 9, 2026

Study Record Updates

• Last Update Posted (Actual): July 9, 2026
• Last Update Submitted That Met QC Criteria: July 3, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity
• Other Study ID Numbers: NN6022-8271; U1111-1333-6460 (Other Identifier: World Health Organization (WHO)); 2026-525179-26 (Other Identifier: EU CT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisktrials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes