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OverweightPhase 1NCT06737536

A First-in-human Research Study on How NNC0662-0419 Works in People Living With Overweight or Obesity

A Phase 1 study testing NNC0662-0419 in people with Overweight and Obesity, run by Novo Nordisk A/S at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is testing a new study medicine which may be used to treat people living with overweight or obesity. The purpose of the study is to see if the new study medicine is safe, how it works in human body and what human body does to the study medicine. Read more about this study

Who is it for?
Ages 19 to 55 years
Conditions the study is for
Overweight, Obesity
What is being tested?
NNC0662-0419
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteUnited States
Study dates
18 Dec 2024to 26 Jul 2025
Phase
Phase 1
Are there results?
None posted in the registry

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 19 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Male or female (sex at birth)
  • Aged 19-55 years (both inclusive) at the time of signing the informed consent.
  • Body mass index (BMI) between 27.0 and 39.9 kilogram per square meter (kg/m^2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
  • Considered eligible 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.

Who cannot join

  • Known or suspected hypersensitivity to study intervention(s) or related products.
  • Any disorder, unwillingness or inability which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
  • 2nd or 3rd degree atrioventricular-block, prolongation of the QRS complex over 120 milliseconds (ms), or of the corrected QT interval by Fridericia (QTcF) calculation over 450 ms (females) or 430 ms (males), or any other clinically significant abnormal ECG results as judged by the investigator, at screening.
  • Glycated haemoglobin (HbA1c) greater than or equal to (>=) 6.5 percent (%) (48 millimoles per mole [mmol/mol]) at screening.
  • Calcitonin >= 50 nanogram per liter (ng/L) at screening

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Celerion, Lincoln

    Lincoln, Nebraska, 68502

Other trials in United States

About this study

Official title: A Single- and Multiple-ascending Dose Study to Investigate Safety, Tolerability and Pharmacokinetics of NNC0662-0419 in Participants Living With Overweight or Obesity

This study is testing a new study medicine which may be used to treat people living with overweight or obesity. The purpose of the study is to see if the new study medicine is safe, how it works in human body and what human body does to the study medicine. Participants will either get the study medicine NNC0662-0419 or placebo (a "dummy" medicine without any active ingredients) given by study staff as an injection under participants skin. Which treatment participants will get is decided by chance. NNC0662-0419 is a new medicine, which cannot be prescribed by doctors. This is the first time the medicine is being given to humans. The study will last for about 9 months.

Conditions
Overweight, Obesity
Being tested
NNC0662-0419, Placebo (NNC0662-0419)
Medical subject headings
Overweight, Obesity

What participants receive

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

  • NNC0662-0419Drug

    Participants will receive NNC0662-0419 subcutaneous (s.c.) once weekly.

  • Placebo (NNC0662-0419)Other

    Participants will receive placebo matched to NNC0662-0419 s.c. once weekly.

Study groups in NCT06737536
Study groupRoleWhat they receive
Part A: Single ascending dose (SAD)ExperimentalParticipants will receive a single dose of any of the five different dose levels of NNC0662-0419 or matching placebo in a sequential manner with the dose increasing between cohorts.
Receives: Drug: NNC0662-0419; Other: Placebo (NNC0662-0419)
Part B: Multiple ascending dose (MAD)ExperimentalParticipants will receive NNC0662-0419 once-weekly for 4 weeks at any of the four different dose levels or matching placebo in a sequential manner with the dose increasing between cohorts.
Receives: Drug: NNC0662-0419; Other: Placebo (NNC0662-0419)

What is being measured

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

  1. Part A: Number of treatment emergent adverse events (TEAE)

    Number of events

    Measured: From timing of dosing on day 1 until completion of the end of study visit (up to 6 weeks)

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

    Number of events

    Measured: From timing of dosing on day 1 until completion of the end of study visit (up to 9 weeks)

Secondary outcomes (4)

  1. Part A: AUC; the area under the NNC0662-0419 plasma concentration-time curve

    measured in hour*nanomoles per liter (h*nmol/L)

    Measured: From pre-dose on day 1 until completion of the end of study visit (up to 6 weeks)

  2. Part A: Cmax; the maximum plasma concentration of NNC0662-0419

    measured in nanomoles per liter(nmol/L)

    Measured: From pre-dose on day 1 until completion of the end of study visit (up to 6 weeks)

  3. Part B: AUC; the area under the NNC0662-0419 plasma concentration-time curve

    measured in h*nmol/L

    Measured: From pre-dose on day 1 until completion of the end of study visit (up to 9 weeks)

  4. Part B: Cmax; the maximum plasma concentration of NNC0662-0419

    measured in nmol/L

    Measured: From pre-dose on day 1 until completion of the end of study visit (up to 9 weeks)

Timeline

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

  1. First posted17 Dec 2024
  2. Study start18 Dec 2024
  3. Primary completion26 Jul 2025
  4. Study completion26 Jul 2025

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
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06737536
Sponsor's protocol ID
NN9662-7694
Other IDs
U1111-1304-7446
Status last verified
Sep 2025
First submitted
12 Dec 2024
Last updated
19 Sep 2025
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 novonordisk-trials.com

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NNC0662-0419 in people with Overweight and Obesity, run by Novo Nordisk A/S at 1 site in United States.

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 4 inclusion and 5 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: finished, as of the sponsor's last update on 19 Sep 2025. 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 United States. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Number of treatment emergent adverse events (TEAE) (time frame: From timing of dosing on day 1 until completion of the end of study visit (up to 6 weeks)). The study lists 2 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 NCT06737536.

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 19 Sep 2025.

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