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NCT Number: NCT07437079

A Study to See How Safe a New Medicine (NNC6989-0001) is in Healthy People Living With Overweight or Obesity

This study is testing a new medicine, NNC6989-0001, to test it is safe and tolerable for healthy people living with overweight or obesity. NNC6989-0001 is still being tested in studies and is not yet available for prescription by doctors. In this study, participants will receive either NNC6989-0001 or a placebo; which treatment each participant receives will be decided by chance.

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, 66219, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male or female of non-childbearing potential.
  • Age 18-55 years (both inclusive) at the time of signing the informed consent.
  • Body mass index (BMI) (at screening) ≥ 25.0 and ≤ 34.9 kg/m^2 for Part A (SAD part) and BMI (at screening) ≥ 25.0 and ≤ 39.9 kg/m^2 for Part B (MAD part).
  • 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.

Exclusion criteria

  • Any condition, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
  • Any clinically significant body weight change (≥5 % self-reported change) or dieting attempts (e.g., participation in a weight reduction program) within 90 days before screening.
  • Treatment with any GLP-1 RA or a medication with GLP-1 activity within 90 days before screening
  • Use of prescription or non-prescription medicinal products within 14 days before screening. This includes over the counter medicines such as laxatives, mineral oil, and fat-blocking supplements. Routine multivitamin/mineral supplements at labelled daily doses are permitted; other non-prescription supplements (e.g., high-dose vitamins, weight-loss supplements) are not permitted. Occasional use of over-the-counter acetaminophen or NSAIDs at their labelled doses for mild pain is permitted.

Treatment and study plan

NNC6989-0001 A

Drug

Participants assigned to the active intervention receive NNC6989-0001 A

Placebo (NNC6989-0001 A)

Drug

Participants assigned to the placebo, receive placebo matched in appearance to the active drug.

Primary outcomes

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

    Time frame: From time of dosing on Day1 until completion of the end of study visit (Day 7)

    Measure in number of events.

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

    Time frame: From time of dosing on Day 1 until completion of the end of study visit (Day 14)

    Measured in number of events

Secondary outcomes

  1. AUC; the area under the NNC6989-0001 plasma concentration-time curve - Part A

    Time frame: From pre-dose on Day 1 until completion of the end of study visit (Day 7)

    Measured in hours times nanograms per millilitre(h*ng/ml).

  2. Cmax; the maximum plasma concentration of NNC6989-0001 - Part A

    Time frame: From pre-dose on Day 1 until completion of the end of study visit (Day 7)

    Measured in nanograms per millilitre(ng/ml).

  3. AUC; the area under the NNC6989-0001 plasma concentration-time curve - Part B

    Time frame: From pre-dose on Day 1 until completion of the end of study visit (Day 14)

    Measured in h*ng/ml.

  4. Cmax; the maximum plasma concentration of NNC6989-0001 - Part B

    Time frame: From pre-dose on Day 1 until completion of the end of study visit (Day 14)

    Measured in ng/ml.

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 First Human Dose Study Investigating Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of Single and Multiple Ascending Doses of NNC6989-0001 in Healthy Participants With Overweight or Obesity

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 27, 2026
Registry last updated
Feb 27, 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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