ObesityPhase 2NCT07639021
A Research Study Comparing Different Ways of Increasing the Dose of NNC0662-0419 in Participants With Obesity
A Phase 2 study testing NNC0662-0419 and Semaglutide in people with Obesity, run by Novo Nordisk A/S at 25 sites in 2 countries.
Trial summary
The purpose of the study is to find out if NNC0662-0419 is safe and effective for treating participants living with obesity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- NNC0662-0419 and Semaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 233 participants
- Where
- 25 sitesin 2 countries
- Study dates
- 9 Jun 2026to 14 Jun 2027
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female (sex assigned at birth, inclusive of all gender identities).
- Age 18 years or above at the time of signing the informed consent.
- Body mass index (BMI) greater than or equal to (≥) 30.0 kilogram per square meter (kg/m^2) at screening.
- Participant must have a desire and be committed to lose at least 25 percentage (%) of their body weight from randomisation.
Who cannot join
- Known or suspected hypersensitivity to study intervention(s) or related products.
- Treatment with any medication prescribed for the indication of obesity or weight management (e.g. glucagon-like-peptide-1 (GLP-1) receptor agonists (RA), dual GLP-1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment) or amylin analogues)) within 90 days before screening.
- Glycated haemoglobin (HbA1c) ≥ 6.5% (48 Millimoles per mole [mmol/mol]) as measured by the central laboratory at screening.
- History of type 1 or type 2 diabetes mellitus.
Trial locations and contacts
25 sites in 2 countries.
25 sites in 2 countries
United States24 sites
Holston Medical Group_Bristol
Bristol, Tennessee, 37620
Cedar-Crosse Research Center
Chicago, Illinois, 60607
Great Lakes Clinical Trials
Chicago, Illinois, 60640
StudyMetrix Research LLC
City of Saint Peters, Missouri, 63303
FDRC
Costa Mesa, California, 92627
Clinical Res Collaborative
Cumberland, Rhode Island, 02864
Encore Medical Research LLC
Hollywood, Florida, 33024
PlanIt Research, PLLC
Houston, Texas, 77079
Midwest Inst For Clin Res
Indianapolis, Indiana, 46260
Holston Medical Group
Kingsport, Tennessee, 37660
Los Angeles Institute for Metabolic Research
Los Angeles, California, 90015
L-MARC Research Center
Louisville, Kentucky, 40213
South Broward Research LLC
Miramar, Florida, 33027
Chambliss Clinical Trials, LLC
Montgomery, Alabama, 36106
Clinical Research Associates
Nashville, Tennessee, 37203
West Orange Endocrinology
Ocoee, Florida, 34761
UPA Ctr Weight and Eating Dis
Philadelphia, Pennsylvania, 19104
Rainier Clin Res Ctr Inc
Renton, Washington, 98057
National Clin Res Inc.
Richmond, Virginia, 23294
Endo And Metab Cons
Rockville, Maryland, 20852
Pinnacle Clinical Research
San Antonio, Texas, 78222
Family Practice Center of Wadsworth Inc.
Wadsworth, Ohio, 44281-9236
Great Lakes Medical Research
Westfield, New York, 14787
KDCILM, LLC & Accellacare US, Inc.
Wilmington, North Carolina, 28401
About this study
Official title: Evaluation of Different Dose Escalation Regimens for NNC0662-0419 in Participants With Obesity
The purpose of the study is to find out if NNC0662-0419 is safe and effective for treating participants living with obesity.
- Conditions
- Obesity
- Being tested
- NNC0662-0419, Semaglutide, NNC0662-0419 Placebo, Semaglutide placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC0662-0419Drug
NNC0662-0419 will be administered subcutaneously.
SemaglutideDrug
Semaglutide will be administered subcutaneously.
NNC0662-0419 PlaceboDrug
Placebo matched to NNC0662-0419 will be administered subcutaneously.
Semaglutide placeboDrug
Placebo matched to semaglutide will be administered subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| NNC0662-0419 | Experimental | Participants will receive NNC0662-0419 administered subcutaneously in a dose-escalation manner. Receives: Drug: NNC0662-0419 |
| NNC0662-0419 placebo | Placebo comparator | Participants will receive NNC0662-0419 placebo administered subcutaneously in a dose-escalation manner. Receives: Drug: NNC0662-0419 Placebo |
| Semaglutide | Experimental | Participants will receive semaglutide administered subcutaneously in a dose-escalation manner. Receives: Drug: Semaglutide |
| Semaglutide placebo | Placebo comparator | Participants will receive semaglutide placebo administered subcutaneously in a dose-escalation manner. Receives: Drug: Semaglutide placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of gastrointestinal adverse events
Measured as number of events.
Measured: From week 0 to week 39
Secondary outcomes (2)
Relative change in body weight
Measured as percentage (%) change.
Measured: From week 0 to week 32
Change in body mass index (BMI)
Measured as kilogram per square meter (kg/m^2).
Measured: From week 0 to week 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start9 Jun 2026
- Primary completion14 Jun 2027 (estimated)
- Study completion14 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 233 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
- NCT07639021
- Sponsor's protocol ID
- NN9662-8649
- Other IDs
- U1111-1333-3475
- Status last verified
- Sep 2026
- First submitted
- 5 Jun 2026
- Last updated
- 16 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 novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Different Dose Escalation Regimens for NNC0662-0419 in Participants With Obesity
- ClinicalTrials.gov ID
- NCT07639021
- Acronym / sponsor ID
- NN9662-8649
- Conditions
- Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 233 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 9 Jun 2026 (actual)
- Primary completion
- 14 Jun 2027 (estimated)
- Study completion
- 14 Jun 2027 (estimated)
- First posted
- 10 Jun 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.
The purpose of the study is to find out if NNC0662-0419 is safe and effective for treating participants living with obesity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NNC0662-0419 | Experimental | Drug: NNC0662-0419Participants will receive NNC0662-0419 administered subcutaneously in a dose-escalation manner. |
| NNC0662-0419 placebo | Placebo comparator | Drug: NNC0662-0419 PlaceboParticipants will receive NNC0662-0419 placebo administered subcutaneously in a dose-escalation manner. |
| Semaglutide | Experimental | Drug: SemaglutideParticipants will receive semaglutide administered subcutaneously in a dose-escalation manner. |
| Semaglutide placebo | Placebo comparator | Drug: Semaglutide placeboParticipants will receive semaglutide placebo administered subcutaneously in a dose-escalation manner. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female (sex assigned at birth, inclusive of all gender identities).
- Age 18 years or above at the time of signing the informed consent.
- Body mass index (BMI) greater than or equal to (≥) 30.0 kilogram per square meter (kg/m^2) at screening.
- Participant must have a desire and be committed to lose at least 25 percentage (%) of their body weight from randomisation.
Key exclusion criteria (4 listed)
- Known or suspected hypersensitivity to study intervention(s) or related products.
- Treatment with any medication prescribed for the indication of obesity or weight management (e.g. glucagon-like-peptide-1 (GLP-1) receptor agonists (RA), dual GLP-1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment) or amylin analogues)) within 90 days before screening.
- Glycated haemoglobin (HbA1c) ≥ 6.5% (48 Millimoles per mole [mmol/mol]) as measured by the central laboratory at screening.
- History of type 1 or type 2 diabetes mellitus.
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 |
|---|---|---|
| NNC0662-0419NNC0662-0419 will be administered subcutaneously. | Drug | NNC0662-0419 |
| SemaglutideSemaglutide will be administered subcutaneously. | Drug | Semaglutide |
| NNC0662-0419 PlaceboPlacebo matched to NNC0662-0419 will be administered subcutaneously. | Drug | NNC0662-0419 placebo |
| Semaglutide placeboPlacebo matched to semaglutide will be administered subcutaneously. | Drug | Semaglutide placebo |
Primary outcome
Number of gastrointestinal adverse events
Time frame: From week 0 to week 39
Measured as number of events.
2 secondary outcomes
Relative change in body weight
Time frame: From week 0 to week 32
Change in body mass index (BMI)
Time frame: From week 0 to week 32
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 16 Sep 2026.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Obesity
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
25 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NNC0662-0419 and Semaglutide in people with Obesity, run by Novo Nordisk A/S at 25 sites in 2 countries.
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: under way, not looking for participants, as of the sponsor's last update on 16 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 25 sites in United States, Puerto Rico. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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?
Number of gastrointestinal adverse events (time frame: From week 0 to week 39). 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 16 Sep 2026.