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OverweightPhase 1NCT07767175

A First-in-human Research Study on How NNC0721-8060 Works in People Living With Overweight or Obesity

A Phase 1 study testing NNC0721-8060 and Semaglutide in people with Overweight and Obesity, run by Novo Nordisk A/S at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of the study is to find out if NNC0721-8060 is safe and how it works in people living with overweight or obesity. 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?
NNC0721-8060 and Semaglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
142 participants
Where
2 sitesUnited States
Study dates
12 Aug 2026to 23 Sep 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 (sex at birth).
  • Age 18-55 years (both inclusive) at the time of signing informed consent.
  • Body Mass Index (BMI) 27.0-34.9 kilograms per square metre (kg/m^2) (both inclusive) at screening, with overweight due to excess adipose tissue as judged by the investigator.
  • Considered eligible based on medical history, physical examination, vital signs, electrocardiogram and clinical laboratory tests at screening, as judged by the investigator.

Who cannot join

  • Known or suspected hypersensitivity to study intervention(s) or related products.
  • Previous randomisation in this study.
  • History of allergies (with the exception of seasonal allergies) or history of anaphylactic reactions.
  • Female who is pregnant, breastfeeding, intends to become pregnant, or is of childbearing potential and not using adequate contraception.
  • Current participation (signed informed consent) in any other interventional clinical study.
  • Exposure to an investigational medicinal product within 30 days or five half-lives of that product (whichever is longer) before screening.
  • Any disorder, unwillingness or inability which, in the investigator's opinion, might jeopardise participant safety or compliance with the protocol.
  • Glycated haemoglobin (HbA1c) greater than or equal to (≥) 6.5 percentage (%) (48 millimoles per mole [mmol/mol]) at screening.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Novo Nordisk contact

(+1) 866-867-7178

clinicaltrials@novonordisk.com

United States2 sites, 2 recruiting

  • ICON Early Phase Services, LLC

    Lenexa, Kansas, 66219

    Recruiting

  • ICON

    San Antonio, Texas, 78209

    Not yet recruiting

Other trials in United States

About this study

Official title: A Study Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0721-8060 in Healthy Adult Participants Living With Overweight or Obesity

The purpose of the study is to find out if NNC0721-8060 is safe and how it works in people living with overweight or obesity.

Conditions
Overweight, Obesity
Being tested
NNC0721-8060, Semaglutide, 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.

  • NNC0721-8060Drug

    NNC0721-8060 will be administered subcutaneously.

  • SemaglutideDrug

    Semaglutide will be administered subcutaneously.

  • PlaceboDrug

    Placebo will be administered subcutaneously.

Study groups in NCT07767175
Study groupRoleWhat they receive
NNC0721-8060ExperimentalParticipants will receive subcutaneous injection of NNC0721-8060.
Receives: Drug: NNC0721-8060
SemaglutideActive comparatorParticipants will receive subcutaneous injection of semaglutide.
Receives: Drug: Semaglutide
PlaceboPlacebo comparatorParticipants will receive subcutaneous injection of placebo.
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 Day 1 to Day 36

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

    Measured as number of events.

    Measured: From Day 1 to Day 57

  3. Part C: Change from baseline in body weight

    Measured as percentage change in body weight.

    Measured: From Day 1 to Day 85

Secondary outcomes (7)

  1. Part A: AUC- Area under the NNC0721-8060 plasma concentration time-curve

    Measured as hour nanomoles per litre (h*nmol/L).

    Measured: From Day 1 to Day 36

  2. Part A: Cmax- Maximum observed plasma concentration of NNC0721-8060

    Measured as nanomoles per litre (nmol/L).

    Measured: From Day 1 to Day 36

  3. Part B: AUC- Area under the NNC0721-8060 plasma concentration time-curve

    Measured as h*nmol/L.

    Measured: From Day 1 to Day 57

  4. Part B: Cmax- Maximum observed plasma concentration of NNC0721-8060

    Measured as nmol/L.

    Measured: From Day 1 to Day 57

  5. Part C: AUC- Area under the NNC0721-8060 plasma concentration time-curve

    Measured as h*nmol/L.

    Measured: From Day 1 to Day 113

  6. Part C: Cmax- Maximum observed plasma concentration of NNC0721-8060

    Measured as nmol/L.

    Measured: From Day 1 to Day 113

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

    Measured as number of events.

    Measured: From Day 1 to Day 113

Timeline

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

  1. First posted17 Aug 2026
  2. Study start12 Aug 2026
  3. Primary completion23 Sep 2027 (estimated)
  4. Study completion23 Sep 2027 (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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
142 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07767175
Sponsor's protocol ID
NN9060-8607
Other IDs
U1111-1334-3077
Status last verified
Aug 2026
First submitted
11 Aug 2026
Last updated
4 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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NNC0721-8060 and Semaglutide 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 4 inclusion and 8 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 4 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 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 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?

Part A: Number of treatment emergent adverse events (TEAE) (time frame: From Day 1 to Day 36). 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 NCT07767175.

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 4 Sep 2026.

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