ClinicalTrials.gg
RecruitingNCT07767175Updated Sep 4, 2026

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

A Phase 1 interventional study of NNC0721-8060 and Semaglutide in Overweight and Obesity, sponsored by Novo Nordisk A/S. Recruiting at 2 sites in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-04.

Primary conditionObesityRegistry: OverweightReclassifiedWhy we changed it
Registry
Overweight — the first condition term the registry derived for this study.
ClinicalTrials.gg
Obesity
Why
  1. The study's listed conditions name Obesity, a narrower term within Overweight.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2026; still recruiting 3 months later.

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Phase 1
Study type
Interventional
Enrollment
142
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 207 studies in Obesity by Novo Nordisk A/S — 48 open to participants now, 66 under way, 26 of them phase 3. Obesity · Novo Nordisk A/S.

Planned enrollment
83rd of 166
142 · median 138
Started
2026
with 46 others
Phase 1
85 of 207
22 open now
Primary completion
2027-09
later than 25 of 65 live
Registered
196th of 207
by date

Among the 207 studies in Obesity by Novo Nordisk A/S, this one is the 83rd largest by planned enrollment of the 166 interventional ones that give a count, is one of 47 that started in 2026, is one of 85 in phase 1, reaches primary completion later than 25 of the 65 other live ones, and was the 196th registered.

Obesity

11,536 studies on the registry are indexed under Obesity; 2,042 are open to participants now.

Browse Obesity studies →

Open to participants now

48 of the 207 studies in Obesity by Novo Nordisk A/S are open now, in 12 countries. Recruiting first, the newest first:

42 more — sign in →

By country, each count listing its studies:

All 48 open studies →

Who these studies take

Of the 1,339 Obesity studies recruiting now, 377 (28%) set no upper age limit and 859 (64%) stop at 75 or younger; 167 take children under 18; 490 take healthy volunteers.

This study: 18 Years to 55 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 207 studies in Obesity by Novo Nordisk A/S, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Overweight
  • Obesity

Browse trials for

04

In context

Obesity Reclassified

11,536 studies on the registry are indexed under Obesity; 2,042 are open to participants now.

This study's planned enrollment of 142 is above the median of 67 across 9,016 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,408 studies on the registry; 105 are open to participants now.

Of its 205 completed or terminated interventional studies of FDA-regulated products, 100 (49%) have results posted.

Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male or female (sex at birth).
  • Age 18-55 years (both inclusive) at the time of signing .
  • (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, and clinical laboratory tests at screening, as judged by the investigator.

Exclusion criteria

Exclusion Criteria:

  • Known or suspected 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 and not using adequate .
  • Current participation (signed ) in any other interventional clinical study.
  • Exposure to an 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.
  • (HbA1c) greater than or equal to (≥) 6.5 percentage (%) (48 millimoles per mole [mmol/mol]) at screening.
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

06

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
142 participants (estimated)

Study arms

  • Experimental
    NNC0721-8060

    Participants will receive subcutaneous injection of NNC0721-8060.

    Drug: NNC0721-8060

  • Active comparator
    Semaglutide

    Participants will receive subcutaneous injection of semaglutide.

    Drug: Semaglutide

  • Placebo comparator
    Placebo

    Participants will receive subcutaneous injection of placebo.

    Drug: Placebo

Interventions

  • DrugNNC0721-8060

    NNC0721-8060 will be administered subcutaneously.

  • Semaglutide will be administered subcutaneously.

  • DrugPlacebo

    Placebo will be administered subcutaneously.

07

What researchers measure

Primary outcomes

  1. Part A: Number of treatment emergent adverse events (TEAE)

    Measured as number of events.

    Time frame: From Day 1 to Day 36

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

    Measured as number of events.

    Time frame: From Day 1 to Day 57

  3. Part C: Change from baseline in body weight

    Measured as percentage change in body weight.

    Time frame: From Day 1 to Day 85

Secondary outcomes

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

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

    Time frame: From Day 1 to Day 36

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

    Measured as nanomoles per litre (nmol/L).

    Time frame: From Day 1 to Day 36

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

    Measured as h\*nmol/L.

    Time frame: From Day 1 to Day 57

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

    Measured as nmol/L.

    Time frame: From Day 1 to Day 57

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

    Measured as h\*nmol/L.

    Time frame: From Day 1 to Day 113

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

    Measured as nmol/L.

    Time frame: From Day 1 to Day 113

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

    Measured as number of events.

    Time frame: From Day 1 to Day 113

08

Study locations

1 of 2 sites recruiting
  • ICON Early Phase Services, LLC
    Lenexa, Kansas 66219, United States
    Recruiting
  • ICON
    San Antonio, Texas 78209, United States
    Not yet recruiting
09

References and documents

Individual participant data

Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Data sharing details ↗ · novonordisk-trials.com

No publications or documents are linked to this record.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2026 (actual). Primary completion is estimated for Sep 2027, 13 months after the start.

Of 334 industry-sponsored phase 1 interventional studies under Obesity, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 15. This study's planned 13 months is above that.

Counting every sponsor, half of 439 studies reached it within 11 months; a quarter within 6 and three quarters within 24.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 11, 2026
First posted
Aug 17, 2026
StartActual
Aug 12, 2026
Primary completionEst.
Sep 23, 2027
CompletionEst.
Sep 23, 2027
Last update
Sep 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT07767175
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Aug 17, 2026
Start date
Aug 12, 2026
Primary completion
Sep 23, 2027 (estimated)
Completion
Sep 23, 2027 (estimated)
Last update
Sep 4, 2026

Study contacts

Novo Nordisk
Contact
clinicaltrials@novonordisk.com
(+1) 866-867-7178
Clinical Transparency (dept. 2834)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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