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OverweightPhase 2NCT07184632

A Research Study on How Well Different Doses of the Medicine NNC0662-0419 Help People Living With Overweight or Obesity

A Phase 2 study testing NNC0662-0419 in people with Overweight and Obesity, run by Novo Nordisk A/S at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study tests how well different doses of the medicine NNC0662-0419 help people living with overweight or obesity. The purpose of the study is to find out if NNC0662-0419 is safe and effective for treating people living with overweight or obesity. Read more about this study

Who is it for?
Ages 18 to 65 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
224 participants
Where
2 sitesUnited States
Study dates
1 Oct 2025to 14 Dec 2026
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female (sex at birth).
  • Age at the time of signing the informed consent:
  • For Part A:18-55 years (both inclusive)
  • For Part B and Part C: 18-65 years (both inclusive)
  • Body Mass Index (BMI) at screening (overweight should be due to excess adipose tissue, as judged by the investigator):
  • For Part A: 27.0-39.9 kilogram per square meter(kg/m^2) (both inclusive)
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  • For Part B and Part C:
  • Greater than or equal to (≥) 27.0 kg/m^2 with the presence of at least one weight-related comorbidity (e.g. hypertension, dyslipidaemia, obstructive sleep apnoea or CV disease), or
  • Greater than or equal to (≥) 30.0 kg/m^2
  • 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.
  • Willingness to obtain a high weight loss (greater than [>] 25 percent [%]).

Who cannot join

  • Known or suspected hypersensitivity to study intervention(s) or related products.
  • Treatment with any compound containing Glucagon-Like Peptide 1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP) or amylin receptor agonism within 90 days before screening.
  • Any condition, 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 (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.
  • Glycosylated haemoglobin (HbA1c) greater than or equal to (≥) 6.5% (48 millimoles per mole [mmol/mol]) at screening.
  • History of type 1 or type 2 diabetes mellitus.
  • Calcitonin greater than or equal to (≥) 50 nanogram per litre (ng/L) at screening.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Celerion, Lincoln

    Lincoln, Nebraska, 68502

  • Celerion, Phoenix

    Tempe, Arizona, 85283

Other trials in United States

About this study

Official title: A Study Investigating Safety, Tolerability and Efficacy of Once-weekly NNC0662-0419 in Participants Living With Overweight or Obesity

This study tests how well different doses of the medicine NNC0662-0419 help people living with overweight or obesity. The purpose of the study is to find out if NNC0662-0419 is safe and effective for treating people living with overweight or obesity. There are 2 study treatments in this study, participants will get either NNC0662-0419, the treatment being tested or placebo, a treatment that has no active medicine in it. NNC0662-0419 is a new medicine which cannot be pre-scribed by doctors but has previously been tested in humans.

Conditions
Overweight, Obesity
Being tested
NNC0662-0419, Placebo
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

    NNC0662-0419 will be administered subcutaneously.

  • PlaceboDrug

    Placebo matched to NNC0662-0419 will be administered subcutaneously.

Study groups in NCT07184632
Study groupRoleWhat they receive
NNC0662-0419ExperimentalParticipants will be randomized to receive NNC0662-0419 subcutaneously (s.c.). The study will be conducted in 3 parts. Part A: Multiple ascending dose (MAD), Part B: Dose range finding (DFR) and Part C (2-week escalation).
Receives: Drug: NNC0662-0419
PlaceboPlacebo comparatorParticipant will be randomized to receive placebo in: The study will be conducted in 3 parts. Part A: Multiple ascending dose (MAD), Part B: Dose range finding (DFR) and Part C (2-week escalation).
Receives: Drug: Placebo

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)

    Measured as number of events.

    Measured: From baseline (week 0) to end of study (up to week 44)

  2. Part B: Relative change in body weight

    Measured as percentage (%).

    Measured: From baseline (week 0) to end of treatment (week 36)

  3. Part C: Occurrence of premature treatment discontinuation (Yes/No)

    Measured as count of participants.

    Measured: At end of treatment (week 24)

Secondary outcomes (12)

  1. Part A: Relative change in body weight

    Measured as percentage (%).

    Measured: From baseline (week 0) to end of treatment (up to week 40)

  2. Part A: Change in body weight

    Measured in kilograms (kg).

    Measured: From baseline (week 0) to end of treatment (up to week 40)

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

    Measured in hours*nanomole per litre (h*nmol/L).

    Measured: From pre-dose on day 1 to completion of the end of study visit (up to week 44)

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

    Measured in nanomole per litre (nmol/L).

    Measured: From pre-dose on day 1 to completion of the end of study visit (up to week 44)

  5. Part B: Change in body weight

    Measured in kg.

    Measured: From baseline (week 0) to end of treatment (week 36)

  6. Part B: Body weight reduction greater than or equal to (≥) 5% (Yes/No)

    Measured as count of participants.

    Measured: From baseline (week 0) to end of treatment (week 36)

  7. Part B: Body weight reduction ≥ 10% (Yes/No)

    Measured as count of participants.

    Measured: From baseline (week 0) to end of treatment (week 36)

  8. Part B: Body weight reduction ≥ 15% (Yes/No)

    Measured as count of participants.

    Measured: From baseline (week 0) to end of treatment (week 36)

  9. Part B: Body weight reduction ≥ 20% (Yes/No)

    Measured as count of participants.

    Measured: From baseline (week 0) to end of treatment (week 36)

  10. Part B: Body weight reduction ≥ 25% (Yes/No)

    Measured as count of participants.

    Measured: From baseline (week 0) to end of treatment (week 36)

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

    Measured as number of events.

    Measured: From baseline (week 0) to end of study (week 39)

  12. Part C: Number of treatment emergent adverse events (TEAE)

    Measured as number of events.

    Measured: From baseline (week 0) to end of study (week 27)

Timeline

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

  1. First posted22 Sep 2025
  2. Study start1 Oct 2025
  3. Primary completion14 Dec 2026 (estimated)
  4. Study completion14 Dec 2026 (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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
224 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07184632
Sponsor's protocol ID
NN9662-8110
Other IDs
U1111-1317-2736
Status last verified
May 2026
First submitted
18 Sep 2025
Last updated
7 May 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NNC0662-0419 in people with Overweight and Obesity, run by Novo Nordisk A/S at 2 sites 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 11 inclusion and 7 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 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 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?

Part A: Number of treatment-emergent adverse events (TEAE) (time frame: From baseline (week 0) to end of study (up to week 44)). 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?

On the ClinicalTrials.gov record for NCT07184632.

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 7 May 2026.

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