Recruiting
Phase 1

NNC6989-0001

Sponsor:

Novo Nordisk A/S

Code:

NCT07437079

Conditions

Overweight

Obesity

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

NNC6989-0001

Placebo (NNC6989-0001)

Study Details

Brief summary:

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.

Conditions

Overweight

Obesity

Study ID

NCT07437079

Start date

Feb 24, 2026

Status verified date

Jul, 2026

Completion date

Jan 21, 2027

Anticipated

Primary completion date

Jan 21, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

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) and Part C (meal timing and potentially meal composition).
  • 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.

Study Design

Enrollment

132 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NNC6989-0001

Participants receive the investigational drug NNC6989-0001

placebo comparator: Placebo

Participants receive placebo matched in appearance to the active drug.

Interventions

NNC6989-0001

Participants assigned to the active intervention receive NNC6989-0001

Placebo (NNC6989-0001)

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

Primary outcome measure

  • 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) ]
  • 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) ]
  • iAUCTG; The incremental area under the blood triglycerides concentration-time curve following meal test - Part C [ Time Frame: Following meal test at Day -1, Day 1, Day 7 and Day 13 ]

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

Jul 29, 2026

Last verified

Jul, 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 2026-07-29.