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Recruiting

NCT Number: NCT07767175

A First-in-human Research Study on How NNC0721-8060 Works in People 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.

Recruiting

Interested in participating?

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON Early Phase Services, LLC, Lenexa, Kansas, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

NNC0721-8060

Drug

NNC0721-8060 will be administered subcutaneously.

semaglutide

Drug

Semaglutide will be administered subcutaneously.

Placebo

Drug

Placebo will be administered subcutaneously.

Primary outcomes

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

    Time frame: From Day 1 to Day 36

    Measured as number of events.

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

    Time frame: From Day 1 to Day 57

    Measured as number of events.

  3. Part C: Change from baseline in body weight

    Time frame: From Day 1 to Day 85

    Measured as percentage change in body weight.

Secondary outcomes

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

    Time frame: From Day 1 to Day 36

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

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

    Time frame: From Day 1 to Day 36

    Measured as nanomoles per litre (nmol/L).

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

    Time frame: From Day 1 to Day 57

    Measured as h*nmol/L.

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

    Time frame: From Day 1 to Day 57

    Measured as nmol/L.

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

    Time frame: From Day 1 to Day 113

    Measured as h*nmol/L.

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

    Time frame: From Day 1 to Day 113

    Measured as nmol/L.

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

    Time frame: From Day 1 to Day 113

    Measured as number of events.

Study contacts

Contact information is provided by the study sponsor or research team.

Novo Nordisk

CONTACT

[email protected]

(+1) 866-867-7178

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 17, 2026
Registry last updated
Sep 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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