OverweightPhase 1NCT07437079
A Study to See How Safe a New Medicine (NNC6989-0001) is in Healthy People Living With Overweight or Obesity
A Phase 1 study testing NNC6989-0001 in people with Overweight and Obesity, run by Novo Nordisk A/S at 1 site in United States.
Trial summary
This study is testing a new medicine, NNC6989-0001, to test it is safe and tolerable for healthy people living with overweight or obesity. NNC6989-0001 is still being tested in studies and is not yet available for prescription by doctors. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- NNC6989-0001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2026to 21 Jan 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female of non-childbearing potential.
- Age 18-55 years (both inclusive) at the time of signing the informed consent.
- Body mass index (BMI) (at screening) ≥ 25.0 and ≤ 34.9 kg/m^2 for Part A (SAD part) and BMI (at screening) ≥ 25.0 and ≤ 39.9 kg/m^2 for Part B (MAD part) and Part C (meal timing and potentially meal composition).
- 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
- Any condition, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- Any clinically significant body weight change (≥5 % self-reported change) or dieting attempts (e.g., participation in a weight reduction program) within 90 days before screening.
- Treatment with any GLP-1 RA or a medication with GLP-1 activity within 90 days before screening
- Use of prescription or non-prescription medicinal products within 14 days before screening. This includes over the counter medicines such as laxatives, mineral oil, and fat-blocking supplements. Routine multivitamin/mineral supplements at labelled daily doses are permitted; other non-prescription supplements (e.g., high-dose vitamins, weight-loss supplements) are not permitted. Occasional use of over-the-counter acetaminophen or NSAIDs at their labelled doses for mild pain is permitted.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
ICON Early Phase Services, LLC
Lenexa, Kansas, 66219
About this study
Official title: A First Human Dose Study Investigating Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of Single and Multiple Ascending Doses of NNC6989-0001 in Healthy Participants With Overweight or Obesity
This study is testing a new medicine, NNC6989-0001, to test it is safe and tolerable for healthy people living with overweight or obesity. NNC6989-0001 is still being tested in studies and is not yet available for prescription by doctors. In this study, participants will receive either NNC6989-0001 or a placebo; which treatment each participant receives will be decided by chance.
- Conditions
- Overweight, Obesity
- Being tested
- NNC6989-0001, Placebo (NNC6989-0001)
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC6989-0001Drug
Participants assigned to the active intervention receive NNC6989-0001
Placebo (NNC6989-0001)Drug
Participants assigned to the placebo, receive placebo matched in appearance to the active drug.
| Study group | Role | What they receive |
|---|---|---|
| NNC6989-0001 | Experimental | Participants receive the investigational drug NNC6989-0001 Receives: Drug: NNC6989-0001 |
| Placebo | Placebo comparator | Participants receive placebo matched in appearance to the active drug. Receives: Drug: Placebo (NNC6989-0001) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment emergent adverse events (TEAE) - Part A
Measure in number of events.
Measured: From time of dosing on Day1 until completion of the end of study visit (Day 7)
Number of treatment emergent adverse events (TEAE) - Part B
Measured in number of events
Measured: From time of dosing on Day 1 until completion of the end of study visit (Day 14)
iAUCTG; The incremental area under the blood triglycerides concentration-time curve following meal test - Part C
Measured in ratio
Measured: Following meal test at Day -1, Day 1, Day 7 and Day 13
Secondary outcomes (6)
AUC; the area under the NNC6989-0001 plasma concentration-time curve - Part A
Measured in hours times nanograms per millilitre(h*ng/ml).
Measured: From pre-dose on Day 1 until completion of the end of study visit (Day 7)
Cmax; the maximum plasma concentration of NNC6989-0001 - Part A
Measured in nanograms per millilitre(ng/ml).
Measured: From pre-dose on Day 1 until completion of the end of study visit (Day 7)
AUC; the area under the NNC6989-0001 plasma concentration-time curve - Part B
Measured in h*ng/ml.
Measured: From pre-dose on Day 1 until completion of the end of study visit (Day 14)
Cmax; the maximum plasma concentration of NNC6989-0001 - Part B
Measured in ng/ml.
Measured: From pre-dose on Day 1 until completion of the end of study visit (Day 14)
AUC; the area under the NNC6989-0001 plasma concentration-time curve - Part C
Measured in h*ng/ml.
Measured: From pre-dose on Day 1 until completion of the end of study visit (Day 20)
Cmax; the maximum plasma concentration of NNC6989-0001 - Part C
Measured in ng/ml.
Measured: From pre-dose on Day 1 until completion of the end of study visit (Day 20)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start24 Feb 2026
- Primary completion21 Jan 2027 (estimated)
- Study completion21 Jan 2027 (estimated)
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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (estimated)
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
- NCT07437079
- Sponsor's protocol ID
- NN6989-8611
- Other IDs
- U1111-1326-7700
- Status last verified
- Jul 2026
- First submitted
- 20 Feb 2026
- Last updated
- 29 Jul 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 novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First Human Dose Study Investigating Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of Single and Multiple Ascending Doses of NNC6989-0001 in Healthy Participants With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT07437079
- Acronym / sponsor ID
- NN6989-8611
- Conditions
- Overweight, Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 24 Feb 2026 (actual)
- Primary completion
- 21 Jan 2027 (estimated)
- Study completion
- 21 Jan 2027 (estimated)
- First posted
- 27 Feb 2026 (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.
This study is testing a new medicine, NNC6989-0001, to test it is safe and tolerable for healthy people living with overweight or obesity. NNC6989-0001 is still being tested in studies and is not yet available for prescription by doctors. In this study, participants will receive either NNC6989-0001 or a placebo; which treatment each participant receives will be decided by chance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NNC6989-0001 | Experimental | Drug: NNC6989-0001Participants receive the investigational drug NNC6989-0001 |
| Placebo | Placebo comparator | Drug: Placebo (NNC6989-0001)Participants receive placebo matched in appearance to the active drug. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or female of non-childbearing potential.
- Age 18-55 years (both inclusive) at the time of signing the informed consent.
- Body mass index (BMI) (at screening) ≥ 25.0 and ≤ 34.9 kg/m^2 for Part A (SAD part) and BMI (at screening) ≥ 25.0 and ≤ 39.9 kg/m^2 for Part B (MAD part) and Part C (meal timing and potentially meal composition).
- 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 (4 listed)
- Any condition, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- Any clinically significant body weight change (≥5 % self-reported change) or dieting attempts (e.g., participation in a weight reduction program) within 90 days before screening.
- Treatment with any GLP-1 RA or a medication with GLP-1 activity within 90 days before screening
- Use of prescription or non-prescription medicinal products within 14 days before screening. This includes over the counter medicines such as laxatives, mineral oil, and fat-blocking supplements. Routine multivitamin/mineral supplements at labelled daily doses are permitted; other non-prescription supplements (e.g., high-dose vitamins, weight-loss supplements) are not permitted. Occasional use of over-the-counter acetaminophen or NSAIDs at their labelled doses for mild pain is permitted.
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 |
|---|---|---|
| NNC6989-0001Participants assigned to the active intervention receive NNC6989-0001 | Drug | NNC6989-0001 |
| Placebo (NNC6989-0001)Participants assigned to the placebo, receive placebo matched in appearance to the active drug. | Drug | Placebo |
Primary outcome
Number of treatment emergent adverse events (TEAE) - Part A
Time frame: From time of dosing on Day1 until completion of the end of study visit (Day 7)
Measure in number of events.
Number of treatment emergent adverse events (TEAE) - Part B
Time frame: From time of dosing on Day 1 until completion of the end of study visit (Day 14)
Measured in number of events
iAUCTG; The incremental area under the blood triglycerides concentration-time curve following meal test - Part C
Time frame: Following meal test at Day -1, Day 1, Day 7 and Day 13
Measured in ratio
6 secondary outcomes
AUC; the area under the NNC6989-0001 plasma concentration-time curve - Part A
Time frame: From pre-dose on Day 1 until completion of the end of study visit (Day 7)
Cmax; the maximum plasma concentration of NNC6989-0001 - Part A
Time frame: From pre-dose on Day 1 until completion of the end of study visit (Day 7)
AUC; the area under the NNC6989-0001 plasma concentration-time curve - Part B
Time frame: From pre-dose on Day 1 until completion of the end of study visit (Day 14)
Cmax; the maximum plasma concentration of NNC6989-0001 - Part B
Time frame: From pre-dose on Day 1 until completion of the end of study visit (Day 14)
AUC; the area under the NNC6989-0001 plasma concentration-time curve - Part C
Time frame: From pre-dose on Day 1 until completion of the end of study visit (Day 20)
Cmax; the maximum plasma concentration of NNC6989-0001 - Part C
Time frame: From pre-dose on Day 1 until completion of the end of study visit (Day 20)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- 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.
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 NNC6989-0001 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 4 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 29 Jul 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 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. 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?
Number of treatment emergent adverse events (TEAE) - Part A (time frame: From time of dosing on Day1 until completion of the end of study visit (Day 7)). The study lists 3 primary outcomes in all. 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 29 Jul 2026.