AzTrials
AzTrials

ObesityPhase 1NCT07693868

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

A Phase 1 study testing NNC6022-0004 in people with Obesity and Elevated High-sensitivity C-reactive Protein (hsCRP), run by Novo Nordisk A/S at 1 site in Netherlands.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
NNC6022-0004
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
128 participants
Where
1 siteNetherlands
Study dates
6 Jul 2026to 3 Aug 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Novo Nordisk contact

(+1) 866-867-7178

clinicaltrials@novonordisk.com

Netherlands1 site, 1 recruiting

  • ICON - location Groningen

    Groningen, 9728 NZ

    Recruiting

Other trials in Netherlands

About this study

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

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.

Read the 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).

Being tested
NNC6022-0004, Placebo
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NNC6022-0004Drug

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

  • PlaceboDrug

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

Study groups in NCT07693868
Study groupRoleWhat they receive
NNC6022-0004ExperimentalParticipants will receive NNC6022-0004 administered orally as a single ascending dose (SAD), multiple ascending dose (MAD), or under fed/fasted conditions.
Receives: Drug: NNC6022-0004
PlaceboPlacebo comparatorParticipants will receive placebo matched to NNC6022-0004 administered orally as a SAD, MAD, or under fed/fasted conditions.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

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

  2. Part A: Maximum observed plasma concentration (Cmax) of NNC6022-0001 after a single dose

    Measured as micromolar (µM).

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

  3. Part B: Number of treatment emergent adverse events (TEAE)

    Measured as number of events.

    Measured: From time of dosing (Day 1) to end of study visit (Day 14)

  4. Part C: Number of treatment emergent adverse events

    Measured as number of events.

    Measured: From time of dosing (Day 1) to end of study visit (Day 41)

  5. 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.

    Measured: From pre-dose (Day 1 or Day 8) to end of visit (Day 5 or Day 12)

  6. Part E: Number of treatment emergent adverse events

    Measured as number of events.

    Measured: From time of dosing (Day 1) to end of study visit (Day 13)

Secondary outcomes (15)

  1. 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.

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

  2. Part A: Number of treatment emergent adverse events

    Measured as number of events.

    Measured: From time of dosing (Day 1) to end of study visit (Day 9)

  3. 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.

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

  4. 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.

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

  5. Part B: The maximum observed plasma concentration (Cmax) of NNC6022-0001 after a single dose

    Measured as µM.

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

  6. Part B: Proportion of administered dose recovered as unchanged drug in urine (Fe0-72h), calculated as Ae0-72hour/ dose

    Measured as proportion of dose.

    Measured: From dose (Day 1) until 72h post-dose

  7. 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.

    Measured: From pre-dose (Day 28) to tau after last dose (Day 29)

  8. Part C: The maximum observed plasma concentration (Cmax) of NNC6022-0001 after last dose

    Measured as µM.

    Measured: From pre-dose (Day 28) until visit 3 (Day 35)

  9. Part C: interleukin β (IL-1β) (ex vivo): ratio of plasma level at time tau after last dose to baseline

    Measured as ratio

    Measured: From pre-dose (Day 1) to tau after last dose (Day 29)

  10. 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.

    Measured: From pre-dose (Day 1 or Day 8) to end of visit (Day 5 or Day 12)

  11. Part D: The maximum observed plasma concentration (Cmax) of NNC6022-0001 after a single dose

    Measured as µM.

    Measured: From pre-dose (Day 1 or Day 8) to end of visit (Day 5 or Day 12)

  12. Part D: Number of treatment emergent adverse events

    Measured as number of events.

    Measured: From time of dosing (Day 1) to end of visit (Day 16)

  13. Part E: Ratio of plasma level at time tau after last dose to baseline (hsCRP)

    Measured as ratio.

    Measured: From pre-dose (Day 1) to tau after last dose (Day 8)

  14. 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 .

    Measured: From pre-dose (Day 7) to tau after last dose (Day 8)

  15. Part E: The maximum observed plasma concentration (Cmax) of NNC6022 0001 after last dose

    Measured as µM.

    Measured: From pre-dose (Day 7) until visit 3 (Day 13)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2026
  2. Study start6 Jul 2026
  3. Primary completion3 Aug 2027 (estimated)
  4. Study completion3 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
128 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07693868
Sponsor's protocol ID
NN6022-8271
Other IDs
U1111-1333-6460, 2026-525179-26
Status last verified
Aug 2026
First submitted
3 Jul 2026
Last updated
1 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisktrials.com

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NNC6022-0004 in people with Obesity and Elevated High-sensitivity C-reactive Protein (hsCRP), run by Novo Nordisk A/S at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Novo Nordisk ((+1) 866-867-7178, clinicaltrials@novonordisk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07693868.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in