Recruiting
Phase 1

NNC0721-8060

Sponsor:

Novo Nordisk A/S

Code:

NCT07767175

Conditions

Overweight

Obesity

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

NNC0721-8060

Semaglutide

Placebo

Study Details

Brief 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.

Conditions

Overweight

Obesity

Study ID

NCT07767175

Start date

Aug 12, 2026

Status verified date

Aug, 2026

Completion date

Sep 23, 2027

Anticipated

Primary completion date

Sep 23, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

142 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NNC0721-8060

Participants will receive subcutaneous injection of NNC0721-8060.

active comparator: Semaglutide

Participants will receive subcutaneous injection of semaglutide.

placebo comparator: Placebo

Participants will receive subcutaneous injection of placebo.

Interventions

NNC0721-8060

NNC0721-8060 will be administered subcutaneously.

Semaglutide

Semaglutide will be administered subcutaneously.

Placebo

Placebo will be administered subcutaneously.

Primary outcome measure

  • Part A: Number of treatment emergent adverse events (TEAE) [ Time Frame: From Day 1 to Day 36 ]
  • Part B: Number of treatment emergent adverse events (TEAE) [ Time Frame: From Day 1 to Day 57 ]
  • Part C: Change from baseline in body weight [ Time Frame: From Day 1 to Day 85 ]

Central Contacts and Locations

Central contacts

Novo Nordisk

(+1) 866-867-7178clinicaltrials@novonordisk.com

Locations

ICON Early Phase Services, LLC

Recruiting

Lenexa, Kansas, United States, 66219

More Information

Sponsor

Novo Nordisk A/S

Last update posted

Sep 4, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Novo Nordisk A/S on 2026-09-04.