OverweightPhase 1NCT07101783
A Research Study on How a Dose of NNC0662-0419 Works in Japanese, Chinese and Non-Asian Participants 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.
Trial summary
The study is testing the new medicine NNC0662-0419 in people living with overweight or obesity. The purpose of the study is to look into the amount of the new medicine NNC0662-0419 in participants blood after one dose. Read more about this study
- Who is it for?
- Ages 18 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?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2025to 31 Oct 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female (sex at birth) Japanese, Chinese or non-Asian participants (all self-reported).
- For Japanese participants: both parents of Japanese descent.
- For Chinese participants: both parents of Chinese descent.
- For non-Asian participants: both parents of non-Asian descent (non-Asian is defined as of countries outside of Asia).
- Age 18-55 years (both inclusive) at the time of signing the informed consent.
- Body mass index (BMI) between 24.0 and 34.9 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 a* or suspected hypersensitivity to study intervention(s) or related products.
- Any disorder, unwillingness or inability which in the investigator's opinion, might jeopardise the participant's safety or compliance with the protocol.
- 2nd or 3rd degree atrioventricular-block, prolongation of the QRS complex over 120 millisecond (msec), or of the corrected QT interval by Fridericia (QTcF) calculation over 450 msec (females) or 430 msec (males), or any other clinically significant abnormal electrocardiogram (ECG) results as judged by the investigator, at screening.
- Glycated haemoglobin (HbA1c) greater than or equal to >= 6.5percent (%) (48 millimoles per liter [mmol/mol]) at screening.
- Calcitonin >= 50 nanogram per liter (ng/L) at screening. a* - As declared by the participant or reported in the medical records.
Trial locations and contacts
1 site in 1 country.
United States1 site
Altasciences Clinical LA, Inc.
Cypress, California, 90630
About this study
Official title: Investigation of Pharmacokinetic Properties of Single Doses of NNC0662-0419 in Japanese, Chinese and Non-Asian Participants Living With Overweight or Obesity
The study is testing the new medicine NNC0662-0419 in people living with overweight or obesity. The purpose of the study is to look into the amount of the new medicine NNC0662-0419 in participants blood after one dose. And also look into how safe and how well the study medicine is tolerated in people living with overweight or obesity. NNC0662-0419 is a new medicine which cannot be prescribed by doctors. NNC0662-0419 is currently being tested in humans and the dose participants will receive has been found safe and tolerable. Participants will get a single dose of NNC0662-0419 given by study staff as a single injection under participants skin. Like all medicines, the study medicine may have side effects. The study will last up to 2 months.
- Conditions
- Overweight, Obesity
- Being tested
- 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 subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| NNC0662-0419 (Dose 1) | Experimental | Participants will receive a single dose (SD) of NNC0662-0419 subcutaneously. Receives: Drug: NNC0662-0419 |
| NNC0662-0419 (Dose 2) | Experimental | Participants will receive a SD of NNC0662-0419 subcutaneously. Receives: Drug: NNC0662-0419 |
| NNC0662-0419 (Dose 3) | Experimental | Participants will receive a SD of NNC0662-0419 subcutaneously. Receives: Drug: NNC0662-0419 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC; The area under the NNC0662-0419 plasma concentration-time curve
Measured in hours*nanomoles per liter (h*nmol/L).
Measured: From pre-dose on Day 1 until completion of the end of study visit (Day 29)
Secondary outcomes (2)
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 (Day 29)
Number of treatment-emergent adverse events (TEAEs)
Measured as number of events.
Measured: From time of dosing on Day 1 until completion of the end of study visit (Day 29)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start1 Aug 2025
- Primary completion31 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07101783
- Sponsor's protocol ID
- NN9662-8159
- Other IDs
- U1111-1315-2937
- Status last verified
- Dec 2025
- First submitted
- 28 Jul 2025
- Last updated
- 23 Dec 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Pharmacokinetic Properties of Single Doses of NNC0662-0419 in Japanese, Chinese and Non-Asian Participants Living With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT07101783
- Acronym / sponsor ID
- NN9662-8159
- Conditions
- Overweight, Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 3 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is testing the new medicine NNC0662-0419 in people living with overweight or obesity. The purpose of the study is to look into the amount of the new medicine NNC0662-0419 in participants blood after one dose. And also look into how safe and how well the study medicine is tolerated in people living with overweight or obesity. NNC0662-0419 is a new medicine which cannot be prescribed by doctors. NNC0662-0419 is currently being tested in humans and the dose participants will receive has been found safe and tolerable. Participants will get a single dose of NNC0662-0419 given by study staff as a single injection under participants skin. Like all medicines, the study medicine may have side effects. The study will last up to 2 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NNC0662-0419 (Dose 1) | Experimental | Drug: NNC0662-0419Participants will receive a single dose (SD) of NNC0662-0419 subcutaneously. |
| NNC0662-0419 (Dose 2) | Experimental | Drug: NNC0662-0419Participants will receive a SD of NNC0662-0419 subcutaneously. |
| NNC0662-0419 (Dose 3) | Experimental | Drug: NNC0662-0419Participants will receive a SD of NNC0662-0419 subcutaneously. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male or female (sex at birth) Japanese, Chinese or non-Asian participants (all self-reported).
- Age 18-55 years (both inclusive) at the time of signing the informed consent.
- Body mass index (BMI) between 24.0 and 34.9 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.
Key exclusion criteria (5 listed)
- Known a* or suspected hypersensitivity to study intervention(s) or related products.
- Any disorder, unwillingness or inability which in the investigator's opinion, might jeopardise the participant's safety or compliance with the protocol.
- 2nd or 3rd degree atrioventricular-block, prolongation of the QRS complex over 120 millisecond (msec), or of the corrected QT interval by Fridericia (QTcF) calculation over 450 msec (females) or 430 msec (males), or any other clinically significant abnormal electrocardiogram (ECG) results as judged by the investigator, at screening.
- Glycated haemoglobin (HbA1c) greater than or equal to >= 6.5percent (%) (48 millimoles per liter [mmol/mol]) at screening.
- Calcitonin >= 50 nanogram per liter (ng/L) at screening. a* - As declared by the participant or reported in the medical records.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NNC0662-0419Participants will receive NNC0662-0419 subcutaneously. | Drug | NNC0662-0419 (Dose 1), NNC0662-0419 (Dose 2), NNC0662-0419 (Dose 3) |
Primary outcome
AUC; The area under the NNC0662-0419 plasma concentration-time curve
Time frame: From pre-dose on Day 1 until completion of the end of study visit (Day 29)
Measured in hours*nanomoles per liter (h*nmol/L).
2 secondary outcomes
Cmax; The maximum plasma concentration of NNC0662-0419
Time frame: From pre-dose on Day 1 until completion of the end of study visit (Day 29)
Number of treatment-emergent adverse events (TEAEs)
Time frame: From time of dosing on Day 1 until completion of the end of study visit (Day 29)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
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 7 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 23 Dec 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?
AUC; The area under the NNC0662-0419 plasma concentration-time curve (time frame: From pre-dose on Day 1 until completion of the end of study visit (Day 29)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Dec 2025.