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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Overweight
• Intervention / Treatment: Drug: NNC6989-0001; Drug: Placebo (NNC6989-0001)

• Study Type: Interventional
• Enrollment (Estimated): 132
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Novo Nordisk; Phone Number: (+1) 866-867-7178; Email: clinicaltrials@novonordisk.com

Study Locations

• United States
  • Kansas
    • Lenexa, Kansas, United States, 66219
      • Recruiting
      • ICON Early Phase Services, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NNC6989-0001; Participants receive the investigational drug NNC6989-0001	Drug: NNC6989-0001; Participants assigned to the active intervention receive NNC6989-0001
Placebo Comparator: Placebo; Participants receive placebo matched in appearance to the active drug.	Drug: Placebo (NNC6989-0001); Participants assigned to the placebo, receive placebo matched in appearance to the active drug.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of treatment emergent adverse events (TEAE) - Part A	Measure in number of events.	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	Measured in number of events	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	Measured in ratio	Following meal test at Day -1, Day 1, Day 7 and Day 13

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC; the area under the NNC6989-0001 plasma concentration-time curve - Part A	Measured in hours times nanograms per millilitre(h*ng/ml).	From pre-dose on Day 1 until completion of the end of study visit (Day 7)
Cmax; the maximum plasma concentration of NNC6989-0001 - Part A	Measured in nanograms per millilitre(ng/ml).	From pre-dose on Day 1 until completion of the end of study visit (Day 7)
AUC; the area under the NNC6989-0001 plasma concentration-time curve - Part B	Measured in h*ng/ml.	From pre-dose on Day 1 until completion of the end of study visit (Day 14)
Cmax; the maximum plasma concentration of NNC6989-0001 - Part B	Measured in ng/ml.	From pre-dose on Day 1 until completion of the end of study visit (Day 14)
AUC; the area under the NNC6989-0001 plasma concentration-time curve - Part C	Measured in h*ng/ml.	From pre-dose on Day 1 until completion of the end of study visit (Day 20)
Cmax; the maximum plasma concentration of NNC6989-0001 - Part C	Measured in ng/ml.	From pre-dose on Day 1 until completion of the end of study visit (Day 20)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2026
• Primary Completion (Estimated): January 21, 2027
• Study Completion (Estimated): January 21, 2027

Study Registration Dates

• First Submitted: February 20, 2026
• First Submitted That Met QC Criteria: February 20, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): July 29, 2026
• Last Update Submitted That Met QC Criteria: July 28, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: NN6989-8611; U1111-1326-7700 (Other Identifier: World Health Organisation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No