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

NCT07693868 | Not Yet Recruiting Phase 1 FDA Drug

• 3 other identifiers: NN6022-8271U1111-1333-64602026-525179-26
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; Elevated High-sensitivity C-reactive Protein (hsCRP)

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (15)

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

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

• Part A: Number of treatment emergent adverse 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

  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

  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

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

Study Arms (2)

NNC6022-0004

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Participants will receive placebo matched to NNC6022-0004 administered orally as a SAD, MAD, or under fed/fasted conditions.

Drug: Placebo

Interventions

NNC6022-0004 DRUG

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

NNC6022-0004

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

ICON - location Groningen

Groningen, 9728 NZ, Netherlands

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Transparency dept. 2834

  Novo Nordisk A/S

  STUDY DIRECTOR

Central Study Contacts

Novo Nordisk

CONTACT

(+1) 866-867-7178; clinicaltrials@novonordisk.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: July 9, 2026
• Study Start: July 6, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: July 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)